A Phase 3 interventional study of Melatonin and Placebo in Breast Cancer - Female, sponsored by Virginia Commonwealth University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Virginia Commonwealth University · Phase 3, Interventional, and Supportive care
This is a double-blind, placebo-controlled trial wherein subjects with breast cancer will be randomized to receive either 20 mg oral melatonin or placebo the night before their first radiotherapy (RT), nightly throughout their RT, and for an additional 2 weeks following the completion of their RT. After informed consent is obtained from eligible subjects, they will then be electronically randomized on a 1:1 ratio to melatonin treatment or placebo. The subjects will be stratified according to treatment duration (less than 3 weeks; equal to or greater than 3 weeks) and prior chemotherapy.
Subjects will be randomized to receive either melatonin or placebo. Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT. Patients with localized breast cancer will receive standard-of-care RT as determined by the treating physician. The RT regimens include: (1) 1 week of accelerated (APBI); (2) 3-4 weeks of an accelerated hypofractionation RT schedule; and (3) 6-8 weeks of a standard RT schedule. No additional concomitant medication or supportive care guidelines are required for this study. Subjects will receive daily melatonin or placebo beginning the night before their course of RT and for an additional 2-week period that extends beyond the conclusion of their RT. Subjects will be given a Study Diary to record their use of study medication. Patients will be followed for 60 days after removal from the study treatment or until death, whichever occurs first. Patients removed from the study treatment for unacceptable adverse events (AEs) will be followed until resolution or stabilization of the adverse event.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 80 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
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Exclusion Criteria
Fatigue brought on by conditions other than cancer such as (the indicated tests are required only if that mechanism of fatigue is suspected):
RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Drug: Melatonin
RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Drug: Placebo
Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
Comparison of FACIT-Fatigue Subscale
Determine if the average increase in fatigue (as measured by the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue subscale) from baseline to completion of RT is different in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue.
Time frame: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
Comparison of Functional Assessment of Chronic Illness Therapy (FACIT-F) Scores in Fatigue From Baseline Until 2 Weeks After Completion of RT in Those Patients Who Received Melatonin Compared to Those Who Received Placebo.
Determine whether the average increase in fatigue from baseline until 2 weeks after completion of RT is less in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue.
Time frame: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
Comparison in Functional Assessment of Chronic Illness Therapy (FACIT) in Fatigue From Baseline Until 8 Weeks After Completion of RT in Those Patients Who Received Melatonin Compared to Those Who Received Placebo.
Determine whether the average increase in fatigue from baseline until 8 weeks after completion of RT is less in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue.
Time frame: Baseline (Day 1) and 8 weeks post RT (variable, approximately 64 weeks)
Comparison of Edmonton Symptom Assessment System (ESAS) Scores Obtained at Baseline Until Completion of RT.
Average increase in symptoms from baseline until completion of RT for those patients who received melatonin compared to those who received placebo. The ESAS assesses 10 symptoms experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and feelings of well-being. The severity of each symptom is rated on a numerical scale of 0-10 (0 = no symptom, 10 = worst possible severity).
Time frame: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
Comparison of the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short Form 8a Scores Obtained at Baseline and at the Completion of RT.
Determine whether the average increase in fatigue (as measured by the PROMIS Fatigue-Short Form 8a) from baseline to completion of RT is less in those patients who received melatonin compared to those who received placebo. The higher score, the worse fatigue. The PROMIS Fatigue-Short Form 8a scale consists of 8 general questions regarding fatigue. The patient rates the intensity of fatigue and related symptoms on a scale of 1-5. The total score can range between 8 and 40, with higher scores denoting more fatigue.
Time frame: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
Determine the Level of Agreement in Reported Fatigue Scores When 2 Different Survey Instruments Are Used to Measure Fatigue.
Compare the scores obtained with the FACIT-Fatigue subscale and the PROMIS Fatigue-Short Form at completion of RT. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue. The PROMIS Fatigue-Short Form 8a scale. It consists of 8 general questions regarding fatigue. The patient rates the intensity of fatigue and related symptoms on a scale of 1-5. The total score can range between 8 and 40, with higher scores denoting more fatigue.
Time frame: Baseline,( Day 1), 2 weeks post radiation therapy completion (variable, approximately 58 weeks)
Compare the Number of Hospital Admissions, Emergency Center Visits, and Medical Days Off Work Between Patients Receiving Melatonin Compared to Placebo.
Determine whether patients receiving melatonin have fewer hospital admissions, emergency center visits, and medical days off work than patients receiving placebo
Time frame: Baseline (day 1) to 8 weeks post RT (variable, approximately 64 weeks)
| Milestone | 20 mg Melatonin | Placebo |
|---|---|---|
| Started | 40 | 40 |
| Completed | 39 | 38 |
| Not completed | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Cronavirus disease (covid-19) precautions | 1 | 0 |
Determine if the average increase in fatigue (as measured by the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue subscale) from baseline to completion of RT is different in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue.
| score on a scale | 20 mg Melatonin | Placebo |
|---|---|---|
| Comparison of FACIT-Fatigue Subscale | -4.39 ± 1.24 | 0.74 ± 1.69 |
Determine whether the average increase in fatigue from baseline until 2 weeks after completion of RT is less in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue.
| score on a scale | 20 mg Melatonin | Placebo |
|---|---|---|
| Comparison of Functional Assessment of Chronic Illness Therapy (FACIT-F) Scores in Fatigue From Baseline Until 2 Weeks After Completion of RT in Those Patients Who Received Melatonin Compared to Those Who Received Placebo. | -2.78 ± 1.5 | 1.3 ± 1.97 |
Determine whether the average increase in fatigue from baseline until 8 weeks after completion of RT is less in those patients who received melatonin than in those who received placebo. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue.
| score on a scale | 20 mg Melatonin | Placebo |
|---|---|---|
| Comparison in Functional Assessment of Chronic Illness Therapy (FACIT) in Fatigue From Baseline Until 8 Weeks After Completion of RT in Those Patients Who Received Melatonin Compared to Those Who Received Placebo. | 0.65 ± 1.31 | 4.58 ± 1.26 |
Average increase in symptoms from baseline until completion of RT for those patients who received melatonin compared to those who received placebo. The ESAS assesses 10 symptoms experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and feelings of well-being. The severity of each symptom is rated on a numerical scale of 0-10 (0 = no symptom, 10 = worst possible severity).
| score on a scale | 20 mg Melatonin | Placebo |
|---|---|---|
| Change in Anxiety | -0.26 ± 0.48 | -0.69 ± 0.32 |
| Change in Best Well Being | 0.29 ± 0.3 | 0.41 ± 0.49 |
| Change in Depression | -2 ± 0.21 | -0.34 ± 0.31 |
| Change in Drowsiness | 1.39 ± 0.39 | 0.81 ± 0.48 |
| Change in Lack of Appetite | 0.35 ± 0.49 | 0.47 ± 0.29 |
| Change in Nausea | 0.19 ± 0.14 | 0.06 ± 0.15 |
| Change in Pain Score | 0.74 ± 0.45 | 1.48 ± 0.52 |
| Change in Shortness of Breath | -0.29 ± 0.26 | -0.44 ± 0.18 |
| Change in Sleep | 0.93 ± 0.38 | -0.07 ± 0.62 |
| Change in Tiredness | 1.81 ± 0.41 | 0.28 ± 0.51 |
Determine whether the average increase in fatigue (as measured by the PROMIS Fatigue-Short Form 8a) from baseline to completion of RT is less in those patients who received melatonin compared to those who received placebo. The higher score, the worse fatigue. The PROMIS Fatigue-Short Form 8a scale consists of 8 general questions regarding fatigue. The patient rates the intensity of fatigue and related symptoms on a scale of 1-5. The total score can range between 8 and 40, with higher scores denoting more fatigue.
| score on a scale | 20 mg Melatonin | Placebo |
|---|---|---|
| Comparison of the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short Form 8a Scores Obtained at Baseline and at the Completion of RT. | 3.51 ± 1.08 | -0.52 ± 1.2 |
Compare the scores obtained with the FACIT-Fatigue subscale and the PROMIS Fatigue-Short Form at completion of RT. The FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials. It consists of 27 general QOL questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue sub-score. The patient rates the intensity of fatigue and its related symptoms on a scale of 0-4. The total score ranges between 0 and 52, with higher scores denoting less fatigue. The PROMIS Fatigue-Short Form 8a scale. It consists of 8 general questions regarding fatigue. The patient rates the intensity of fatigue and related symptoms on a scale of 1-5. The total score can range between 8 and 40, with higher scores denoting more fatigue.
| score on a scale | 20 mg Melatonin | Placebo |
|---|---|---|
| FACIT | -4.39 ± 1.24 | 0.74 ± 1.69 |
| PROMIS | 3.51 ± 1.08 | -0.52 ± 1.2 |
Determine whether patients receiving melatonin have fewer hospital admissions, emergency center visits, and medical days off work than patients receiving placebo
| Participants | 20 mg Melatonin | Placebo |
|---|---|---|
| Emergency Department Visit | 6 | 3 |
| Hospital Admission | 7 | 5 |
| Medical Day Off From Work | 15 | 4 |
Collected over 30 days following completion of treatment, an average of 20 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 20 mg Melatonin | 0/39 (0%) | 0/39 (0%) | 37/39 (94.9%) |
| Placebo | 1/38 (2.6%) | 3/38 (7.9%) | 37/38 (97.4%) |
| Event | 20 mg Melatonin | Placebo |
|---|---|---|
| Creatinine IncreasedInvestigations | 0/39 | 1/38 |
| HyponatremiaMetabolism and nutrition disorders | 0/39 | 1/38 |
| DizzinessNervous system disorders | 0/39 | 1/38 |
| Nervous System Disorders-Other, specifyNervous system disorders | 0/39 | 1/38 |
| ConfusionPsychiatric disorders | 0/39 | 1/38 |
| DepressionPsychiatric disorders | 0/39 | 1/38 |
| Event | 20 mg Melatonin | Placebo |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 37/39 | 37/38 |
| FatigueGeneral disorders | 32/39 | 31/38 |
| Dermatitis RadiationInjury, poisoning and procedural complications | 25/39 | 27/38 |
| SomnolenceNervous system disorders | 27/39 | 21/38 |
| HeadacheNervous system disorders | 21/39 | 15/38 |
| DepressionPsychiatric disorders | 16/39 | 18/38 |
| AnxietyPsychiatric disorders | 18/39 | 15/38 |
| DizzinessNervous system disorders | 16/39 | 9/38 |
| NauseaGastrointestinal disorders | 10/39 | 12/38 |
| Abdominal PainGastrointestinal disorders | 12/39 | 8/38 |
| Age, Customized(years) | 20 mg Melatonin | Placebo | Total |
|---|---|---|---|
| Median | 54 (35 to 73) | 58 (38 to 78) | 56.5 (35 to 78) |
| Sex: Female, Male(Participants) | 20 mg Melatonin | Placebo | Total |
|---|---|---|---|
| Female | 39 | 38 | 77 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | 20 mg Melatonin | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 39 | 37 | 76 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 20 mg Melatonin | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 11 | 21 |
| White | 27 | 27 | 54 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | 20 mg Melatonin | Placebo | Total |
|---|---|---|---|
| United States | 39 | 38 | 77 |
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Virginia Commonwealth University