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CompletedNCT02781792Updated Jun 27, 2025Results posted

Temozolomide Chronotherapy for High Grade Glioma

A Phase 2 interventional study of Temozolomide and Functional Assessment of Cancer Therapy - Brain in Glioma and Glioblastoma Multiforme, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life of this drug and known oscillations in DNA damage repair make it an ideal candidate for chronotherapy.

Chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and maximizing efficacy through delivery of a medication according to the timing of biological rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side effects and increase in anti-tumor activity for a variety of cancers, but has never been applied to the treatment of gliomas.

Based on the preliminary preclinical data for chronotherapeutic TMZ treatment of intracranial glioma xenografts and the success of chronotherapy in the treatment of other cancers, the investigators hypothesize that the timing of TMZ treatment will alter its efficacy and toxicity.

02

Conditions studied

  • Glioma
  • Glioblastoma Multiforme
03

In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's enrollment of 42 is above the median of 32 across 1,065 interventional studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Newly diagnosed and recurrent high grade gliomas (WHO grades III \& IV) and high risk WHO grade II gliomas who are to begin treatment with monthly high dose temozolomide therapy.
  • Scheduled to receive adjuvant temozolomide therapy after having completed concurrent temozolomide and radiation therapy.
  • At least 18 years of age.
  • Karnofsky performance status ≥ 60%
  • Ability to understand and willingness to sign an IRB approved written informed consent document

Exclusion Criteria:.

-Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Arm 1: Temozolomide morning

    * Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00). * FACT-Br quality of life at baseline, at the beginning of each cycle of chemotherapy, and 1 month after the final chemotherapy treatment

    Drug: Temozolomide · Other: Functional Assessment of Cancer Therapy - Brain · Other: ActTrust Condor Instrument Watch

  • Experimental
    Arm 2: Temozolomide evening

    * Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00). * FACT-Br quality of life at baseline, at the beginning of each cycle of chemotherapy, and 1 month after the final chemotherapy treatment

    Drug: Temozolomide · Other: Functional Assessment of Cancer Therapy - Brain · Other: ActTrust Condor Instrument Watch

Interventions

  • DrugTemozolomide

    -Given standard of care

    Also known as: Temodar

  • OtherFunctional Assessment of Cancer Therapy - Brain

    * 23-item questionnaire that can be completed in 5 to 10 minutes with little or no assistance in patients who are not neurologically incapacitated. This brain subscale is usually used along with the core (general) questionnaire \[2\] that includes 27 items. * Patients rate all 5 items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher QOL. Items are totaled to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items) * The sleep portion of this questionnaire consists of 17 questions about sleeping patterns and the ability to rate severity of insomnia.

    Also known as: FACT-Br

  • OtherActTrust Condor Instrument Watch

    -Will be required to wear 24 hours per day and will only be removed at specified data collection time points

06

What researchers measure

Primary outcomes

  1. Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time

    Compliance is defined as no more than one of five doses of temozolomide per cycle taken outside of the assigned administration time.

    Time frame: Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)

  2. Duration of Response

    * Response and progression will be evaluated in this study using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline \[JCO 28(11): 1963-1972, 2010\]. * The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

    Time frame: Through completion of follow-up (estimated to be 30 months)

Secondary outcomes

  1. Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws

    * Lymphopenia grade 3 is \<500-200/mm\^3 and grade 4 is \<200/mm\^3 * Leukopenia grade 3 is \<2000-1000/mm\^3 and grade 4 is \<1000/mm\^3 * Neutropenia grade 3 is \<1000-500/mm\^3 and grade 4 is \<500/mm\^3 * Thrombocytopenia grade 3 is \<50,000-25,000/mm\^3 and grade 4 is \<25,000/mm\^3 * Anemia grade 3 is \<8.0-6.5 g/dL and grade 4 is \<6.5 g/dL

    Time frame: Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)

  2. Change in Quality of Life as Measured by FACT-Br Score - Physical Well-being Score

    7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range is 0-28. A higher score indicates a lower physical well-being quality of life.

    Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))

  3. Change in Quality of Life as Measured by FACT-Br Score - Social/Family Well-being Score

    7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher social/family well-being quality of life.

    Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))

  4. Change in Quality of Life as Measured by FACT-Br Score - Emotional Well-being Score

    6-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-24. A higher score indicates a lower emotional well-being quality of life.

    Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))

  5. Change in Quality of Life as Measured by FACT-Br Score - Functional Well-being Score

    7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher emotional well-being quality of life.

    Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))

  6. Median Progression-free Survival (PFS)

    PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

    Time frame: Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)

  7. Median Overall Survival

    Time frame: Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)

  8. Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening

    Sleep Questionnaire - 1 yes/no question of "do you have problems getting to sleep or staying asleep?"

    Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))

  9. Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening

    \- Sleep Questionnaire: * Difficulty falling asleep/difficulty staying asleep/problem waking up too early: Answers range from 0=none, mild=1, moderate=2, severe=3, very=4. * How satisfied or dissatisfied are you with your current sleeping pattern question: Answers range from 0=very satisfied to 4=very dissatisfied. * To what extent do you consider your sleep problem to interfere with your daily functioning question: Answers range from 0=not at all interfering, 1=a little, 2=somewhat, 3=much, 4=very much interfering. * How noticeable to others do you think your sleep problem is in terms of impairing the quality of your life question: Answers range from 0=not at all noticeable, 1=barely, 2 = somewhat, 3 =much, 4=very noticeable. * How worried or distressed are you about your current sleep problem question: Answers range from 0=not at all=0, 1=a little, 2=somewhat, 3=much, 4=very much.

    Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))

  10. Mean Circadian Amplitude

    * The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment. * Circadian amplitude, refers to the difference between the highest and lowest points of a circadian rhythm over a 24-hour cycle, is typically measured in the units of the rhythm being quantified. * The circadian mean amplitude was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.

    Time frame: From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)

  11. Mean Sleep Regularity Index (SRI)

    * The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment. * Sleep regularity index (SRI) is the probability of being at rest, calculated per day for each patient. An SRI closer to 0 indicates irregular sleep patterns (i.e., more variable day to day), while values closer to 1 indicate regular sleep patterns. The SRI index scale is 0\~1. * The SRI was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.

    Time frame: From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)

07

Results

Posted Jun 27, 2025

Participant flow

Participant flow — Overall Study
MilestoneArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Started2220
Completed1715
Not completed55
Withdrew: Adverse event12
Withdrew: Withdrawal by subject31
Withdrew: Lack of efficacy11
Withdrew: Hospice01

Outcome measures

PrimaryFeasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time

Compliance is defined as no more than one of five doses of temozolomide per cycle taken outside of the assigned administration time.

Time frame:
Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)
Reported as:
Count of participants · Participants
Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time
ParticipantsArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time1715
PrimaryDuration of Response

* Response and progression will be evaluated in this study using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline \[JCO 28(11): 1963-1972, 2010\]. * The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

Time frame:
Through completion of follow-up (estimated to be 30 months)

No measurements were reported for this outcome.

SecondaryNumber of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws

* Lymphopenia grade 3 is \<500-200/mm\^3 and grade 4 is \<200/mm\^3 * Leukopenia grade 3 is \<2000-1000/mm\^3 and grade 4 is \<1000/mm\^3 * Neutropenia grade 3 is \<1000-500/mm\^3 and grade 4 is \<500/mm\^3 * Thrombocytopenia grade 3 is \<50,000-25,000/mm\^3 and grade 4 is \<25,000/mm\^3 * Anemia grade 3 is \<8.0-6.5 g/dL and grade 4 is \<6.5 g/dL

Time frame:
Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)
Reported as:
Count of participants · Participants
Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws
ParticipantsArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Lymphopenia20
Thrombocytopenia10
Neutropenia01
Anemia10
Leukopenia10
SecondaryChange in Quality of Life as Measured by FACT-Br Score - Physical Well-being Score

7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range is 0-28. A higher score indicates a lower physical well-being quality of life.

Time frame:
Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Reported as:
Mean · score on a scale
Change in Quality of Life as Measured by FACT-Br Score - Physical Well-being Score
score on a scaleArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Baseline6.23 ± 4.174.80 ± 4.27
Cycle 15.78 ± 4.964.00 ± 2.83
Cycle 27.66 ± 6.928.32 ± 5.65
Cycle 37.33 ± 5.677.69 ± 5.31
Cycle 46.18 ± 4.095.53 ± 4.74
Cycle 55.27 ± 4.547.03 ± 5.80
Cycle 64.64 ± 3.445.71 ± 5.59
Cycle 74.71 ± 4.193.00 ± 2.71
Cycle 83.83 ± 4.363.50 ± 4.14
Cycle 96.83 ± 4.624.00 ± 4.64
Cycle 105.35 ± 4.652.00 ± 1.63
Cycle 115.60 ± 5.592.00 ± 1.41
Cycle 124.50 ± 5.922.00 ± 1.00
End of treatment5.19 ± 4.585.46 ± 3.82
SecondaryChange in Quality of Life as Measured by FACT-Br Score - Social/Family Well-being Score

7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher social/family well-being quality of life.

Time frame:
Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Reported as:
Mean · score on a scale
Change in Quality of Life as Measured by FACT-Br Score - Social/Family Well-being Score
score on a scaleArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Baseline24.10 ± 4.0922.94 ± 3.98
Cycle 124.29 ± 4.1322.59 ± 4.52
Cycle 222.45 ± 7.3223.12 ± 4.18
Cycle 323.14 ± 5.9322.26 ± 5.67
Cycle 423.21 ± 3.7123.06 ± 4.78
Cycle 522.91 ± 4.7222.30 ± 5.59
Cycle 622.44 ± 5.4123.05 ± 5.13
Cycle 720.95 ± 6.3124.86 ± 2.86
Cycle 822.78 ± 3.1522.47 ± 4.26
Cycle 922.25 ± 4.4022.52 ± 4.92
Cycle 1022.94 ± 5.5623.25 ± 2.63
Cycle 1123.77 ± 3.0926.08 ± 2.01
Cycle 1224.00 ± 2.9424.39 ± 1.99
End of treatment21.95 ± 4.2122.73 ± 4.38
SecondaryChange in Quality of Life as Measured by FACT-Br Score - Emotional Well-being Score

6-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-24. A higher score indicates a lower emotional well-being quality of life.

Time frame:
Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Reported as:
Mean · score on a scale
Change in Quality of Life as Measured by FACT-Br Score - Emotional Well-being Score
score on a scaleArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Baseline6.72 ± 3.727.60 ± 3.19
Cycle 16.69 ± 4.698.11 ± 2.85
Cycle 26.06 ± 4.826.77 ± 2.10
Cycle 36.63 ± 3.486.92 ± 2.14
Cycle 47.04 ± 3.255.47 ± 2.70
Cycle 56.68 ± 1.825.36 ± 2.01
Cycle 66.23 ± 3.455.57 ± 1.51
Cycle 77.29 ± 2.565.14 ± 2.73
Cycle 85.50 ± 3.155.67 ± 1.51
Cycle 97.33 ± 2.734.70 ± 1.99
Cycle 106.08 ± 3.585.25 ± 1.71
Cycle 118.60 ± 3.215.50 ± 1.91
Cycle 126.25 ± 2.228.33 ± 1.53
End of treatment5.44 ± 3.225.62 ± 2.40
SecondaryChange in Quality of Life as Measured by FACT-Br Score - Functional Well-being Score

7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher emotional well-being quality of life.

Time frame:
Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Reported as:
Mean · score on a scale
Change in Quality of Life as Measured by FACT-Br Score - Functional Well-being Score
score on a scaleArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Baseline18.19 ± 6.3916.35 ± 7.06
Cycle 118.71 ± 7.0915.89 ± 7.59
Cycle 215.94 ± 8.6816.11 ± 7.17
Cycle 316.37 ± 5.5917.69 ± 5.86
Cycle 417.75 ± 6.8218.78 ± 6.93
Cycle 517.32 ± 7.2319.27 ± 7.86
Cycle 618.64 ± 7.6620.00 ± 7.28
Cycle 718.71 ± 6.3423.57 ± 5.77
Cycle 818.50 ± 7.1821.00 ± 5.59
Cycle 917.00 ± 5.6620.00 ± 6.89
Cycle 1014.58 ± 8.4825.00 ± 3.16
Cycle 1118.80 ± 4.6023.50 ± 4.12
Cycle 1217.50 ± 6.2423.33 ± 6.43
End of treatment17.13 ± 8.2418.54 ± 6.73
SecondaryMedian Progression-free Survival (PFS)

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Time frame:
Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)
Reported as:
Median · months
Median Progression-free Survival (PFS)
monthsArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Median Progression-free Survival (PFS)11.5978 (7.1952 to 29.6680)8.1809 (3.1869 to NA)
SecondaryMedian Overall Survival
Time frame:
Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)
Reported as:
Median · months
Median Overall Survival
monthsArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Median Overall Survival26.9739 (10.6121 to 44.3869)17.1831 (8.3451 to NA)
SecondaryComparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening

Sleep Questionnaire - 1 yes/no question of "do you have problems getting to sleep or staying asleep?"

Time frame:
Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Reported as:
Count of participants · Participants
Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening
ParticipantsArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Baseline — Yes24
Baseline — No42
Cycle 1 — Yes23
Cycle 1 — No22
Cycle 2 — Yes12
Cycle 2 — No33
Cycle 3 — Yes22
Cycle 3 — No23
Cycle 4 — Yes10
Cycle 4 — No35
Cycle 5 — Yes11
Cycle 5 — No14
Cycle 6 — Yes10
Cycle 6 — No23
Cycle 7 — Yes10
Cycle 7 — No21
Cycle 8 — Yes00
Cycle 8 — No21
Cycle 9 — Yes20
Cycle 9 — No01
Cycle 10 — Yes20
Cycle 10 — No01
Cycle 11 — Yes10
Cycle 11 — No11
Cycle 12 — Yes10
Cycle 12 — No11
End of Treatment — Yes10
End of Treatment — No26
SecondaryComparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening

\- Sleep Questionnaire: * Difficulty falling asleep/difficulty staying asleep/problem waking up too early: Answers range from 0=none, mild=1, moderate=2, severe=3, very=4. * How satisfied or dissatisfied are you with your current sleeping pattern question: Answers range from 0=very satisfied to 4=very dissatisfied. * To what extent do you consider your sleep problem to interfere with your daily functioning question: Answers range from 0=not at all interfering, 1=a little, 2=somewhat, 3=much, 4=very much interfering. * How noticeable to others do you think your sleep problem is in terms of impairing the quality of your life question: Answers range from 0=not at all noticeable, 1=barely, 2 = somewhat, 3 =much, 4=very noticeable. * How worried or distressed are you about your current sleep problem question: Answers range from 0=not at all=0, 1=a little, 2=somewhat, 3=much, 4=very much.

Time frame:
Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Reported as:
Count of participants · Participants
Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening
ParticipantsArm 1: Temozolomide Morning BASELINEArm 2: Temozolomide Evening BASELINEArm 1: Temozolomide Morning CYCLE 1Arm 2: Temozolomide Evening CYCLE 1Arm 1: Temozolomide Morning CYCLE 2Arm 2: Temozolomide Evening CYCLE 2Arm 1: Temozolomide Morning CYCLE 3Arm 2: Temozolomide Evening CYCLE 3Arm 1: Temozolomide Morning CYCLE 4Arm 2: Temozolomide Evening CYCLE 4Arm 1: Temozolomide Morning CYCLE 5Arm 2: Temozolomide Evening CYCLE 5Arm 1: Temozolomide Morning CYCLE 6Arm 2: Temozolomide Evening CYCLE 6Arm 1: Temozolomide Morning CYCLE 7Arm 2: Temozolomide Evening CYCLE 7Arm 1: Temozolomide Morning CYCLE 8Arm 2: Temozolomide Evening CYCLE 8Arm 1: Temozolomide Morning CYCLE 9Arm 2: Temozolomide Evening CYCLE 9Arm 1: Temozolomide Morning CYCLE 10Arm 2: Temozolomide Evening CYCLE 10Arm 1: Temozolomide Morning CYCLE 11Arm 2: Temozolomide Evening CYCLE 11Arm 1: Temozolomide Morning CYCLE 12Arm 2: Temozolomide Evening CYCLE 12Arm 1: Temozolomide Morning END OF TREATMENTArm 2: Temozolomide Evening END OF TREATMENT
Difficulty falling asleep — 03121323024241311011010101022
Difficulty falling asleep — 11211210411112110100111110103
Difficulty falling asleep — 22112021110100010101010001011
Difficulty falling asleep — 30201001000000000001000000000
Difficulty falling asleep — 40000000000000000000000000000
Difficulty staying asleep — 04222303033111110001111111122
Difficulty staying asleep — 10101130401231301210010101013
Difficulty staying asleep — 22120111111111020001010000001
Difficulty staying asleep — 30202011000000000001000000000
Difficulty staying asleep — 40000000000000000000000000000
Problem waking up too early — 03131314121142321001121202123
Problem waking up too early — 11201230113311100211010010013
Problem waking up too early — 22313010211000010001000000000
Problem waking up too early — 30000001000000000000000000000
Problem waking up too early — 40000000100000000000000000000
How satisfied or dissatisfied are you with your current sleeping pattern? — 03020202011001010001010111022
How satisfied or dissatisfied are you with your current sleeping pattern? — 10000231122221211011011100110
How satisfied or dissatisfied are you with your current sleeping pattern? — 23323111201211110200010001002
How satisfied or dissatisfied are you with your current sleeping pattern? — 30201011210010100001100000002
How satisfied or dissatisfied are you with your current sleeping pattern? — 40101000001010000000000000000
To what extent do you consider your sleep problem to interfere with your daily functioning? — 03212302110211110002010101030
To what extent do you consider your sleep problem to interfere with your daily functioning? — 11202041213122221110121111104
To what extent do you consider your sleep problem to interfere with your daily functioning? — 22130200011110100101000000002
To what extent do you consider your sleep problem to interfere with your daily functioning? — 30000012200000000000000000000
To what extent do you consider your sleep problem to interfere with your daily functioning? — 40101000011010000000000000000
How noticeable to others is your sleep problem is in terms of impairing the quality of your life — 03010222022221220101010101032
How noticeable to others is your sleep problem is in terms of impairing the quality of your life — 11202021311111211011121111102
How noticeable to others is your sleep problem is in terms of impairing the quality of your life — 22231310102120000101000000002
How noticeable to others is your sleep problem is in terms of impairing the quality of your life — 30202001100001000000000000000
How noticeable to others is your sleep problem is in terms of impairing the quality of your life — 40000001010000000000000000000
How worried or distressed are you about your current sleep problem? — 03222222133231411011111111125
How worried or distressed are you about your current sleep problem? — 12212222201110020101020101011
How worried or distressed are you about your current sleep problem? — 21211110210102000100000000000
How worried or distressed are you about your current sleep problem? — 30000001000000000001000000000
How worried or distressed are you about your current sleep problem? — 40000000001010000000000000000
SecondaryMean Circadian Amplitude

* The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment. * Circadian amplitude, refers to the difference between the highest and lowest points of a circadian rhythm over a 24-hour cycle, is typically measured in the units of the rhythm being quantified. * The circadian mean amplitude was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.

Time frame:
From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)
Reported as:
Mean · counts/minute
Mean Circadian Amplitude
counts/minuteArm 1: Temozolomide MorningArm 2: Temozolomide Evening
AM Patient #10.78 ± 0.02—
AM Patient #20.78 ± 0.01—
PM Patient #1—0.81 ± 0.01
PM Patient #2—0.78 ± 0.01
PM Patient #3—0.77 ± 0.02
PM Patient #4—0.81 ± 0.01
SecondaryMean Sleep Regularity Index (SRI)

* The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment. * Sleep regularity index (SRI) is the probability of being at rest, calculated per day for each patient. An SRI closer to 0 indicates irregular sleep patterns (i.e., more variable day to day), while values closer to 1 indicate regular sleep patterns. The SRI index scale is 0\~1. * The SRI was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.

Time frame:
From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)
Reported as:
Mean · units on a scale
Mean Sleep Regularity Index (SRI)
units on a scaleArm 1: Temozolomide MorningArm 2: Temozolomide Evening
AM Patient #10.70 ± 0.09—
AM Patient #20.79 ± 0.8—
PM Patient #1—0.82 ± 0.09
PM Patient #2—0.69 ± 0.10
PM Patient #3—0.68 ± 0.08
PM Patient #4—0.82 ± 0.11

Adverse events

Collected over All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days) Adverse events were collected from start of treatment through end of treatment visit (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1: Temozolomide Morning7/22 (31.8%)6/22 (27.3%)4/22 (18.2%)
Arm 2: Temozolomide Evening6/20 (30%)5/20 (25%)1/20 (5%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Death due to disease progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/220/20
SeizureNervous system disorders0/221/20
Lung infectionInfections and infestations0/221/20
HeadacheNervous system disorders0/221/20
SepsisInfections and infestations0/221/20
HydrocephalusNervous system disorders0/221/20
Aspartate aminotransferase increasedInvestigations1/220/20
Alanine aminotransferase increasedInvestigations1/220/20
FallInjury, poisoning and procedural complications1/220/20
Vascular access complicationInjury, poisoning and procedural complications1/220/20
Most frequent other events
Most frequent other events
EventArm 1: Temozolomide MorningArm 2: Temozolomide Evening
Lymphocyte count decreasedInvestigations2/220/20
Neutrophil count decreasedInvestigations0/221/20
AnemiaBlood and lymphatic system disorders1/220/20
Platelet count decreasedInvestigations1/220/20
White blood cell count decreasedInvestigations1/220/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm 1: Temozolomide MorningArm 2: Temozolomide EveningTotal
Mean58.59 ± 12.3553.05 ± 17.5255.95 ± 15.11
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1: Temozolomide MorningArm 2: Temozolomide EveningTotal
Female12618
Male101424
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm 1: Temozolomide MorningArm 2: Temozolomide EveningTotal
Hispanic or Latino112
Not Hispanic or Latino211839
Unknown or Not Reported011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm 1: Temozolomide MorningArm 2: Temozolomide EveningTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander011
Black or African American202
White191837
More than one race000
Unknown or Not Reported112
Region of Enrollment
Region of Enrollment(participants)Arm 1: Temozolomide MorningArm 2: Temozolomide EveningTotal
United States222042
08

Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
09

References and documents

Publications

  • Damato AR, Katumba RGN, Luo J, Atluri H, Talcott GR, Govindan A, Slat EA, Weilbaecher KN, Tao Y, Huang J, Butt OH, Ansstas G, Johanns TM, Chheda MG, Herzog ED, Rubin JB, Campian JL. A randomized feasibility study evaluating temozolomide circadian medicine in patients with glioma. Neurooncol Pract. 2022 Jan 31;9(3):193-200. doi: 10.1093/nop/npac003. eCollection 2022 May. PubMed 35601970 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 20, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02781792
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
May 24, 2016
Start date
Aug 11, 2016
Primary completion
Jul 18, 2024
Completion
Jul 18, 2024
Results posted
Jun 27, 2025
Last update
Jun 27, 2025

Study contacts

Milan Chheda, M.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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