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CompletedNCT01175837Updated Dec 12, 2018

Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

An interventional study of questionnaire administration and preventative dietary intervention in Malignant Neoplasm, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-12.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This clinical trial studies short-term fasting before chemotherapy in treating patients with cancer. Fasting before chemotherapy may protect normal cells from the side effects of chemotherapy.

Read the detailed description

PRIMARY OBJECTIVES:

I. Assess the safety and feasibility of short-term fasting prior to administration of chemotherapy.

SECONDARY OBJECTIVES:

I. Evaluate weight changes in patients who are exposed to short-term fasting prior to chemotherapy.

II. Get a preliminary estimate of the longest feasible fasting period prior to chemotherapy.

III. Evaluate the toxicity profile of systemic chemotherapy treatment in patients who undergo short-term fasting prior to treatment.

IV. Investigate changes in plasma glucose, insulin, Insulin-like growth factor 1 (IGF-1) and IGF-1binding proteins (BP) in patients who undertake short-term fasting.

OUTLINE:

COHORT I: Patients fast 24 hours before day 1 of course 2 of chemotherapy. If fast is well tolerated, patients may escalate fasting by 12 hours for each subsequent course of chemotherapy for up to 3 courses in the absence of unacceptable toxicity.

COHORT II: Patients fast at the longest fasting regimen found to be safe and tolerable in cohort I before day 1 of each course of course of chemotherapy for up to 4 courses in the absence of unacceptable toxicity.

02

Conditions studied

  • Malignant Neoplasm

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 12 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) 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

Inclusion criteria

  • Histologically confirmed malignancy
  • Scheduled to undergo 4 or more cycles of chemotherapy (with or without past chemotherapy treatment); NOTE: Acceptable chemotherapy regimens are those that have all drugs infused on the first day of the chemotherapy cycle over a period =\< 8 hours; EXCEPTION: Continuous 5-FU-containing regimens (such as FOLFOX6 and FOLFIRI) are allowed as both the 5-FU bolus as well as the oxaliplatin and irinotecan administration is completed on day 1 of chemotherapy
  • Life expectancy of >= 168 days (6 months)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Body mass index (BMI) > 21 kg/m\^2
  • Weight loss \< 5% of body weight in the last 168 days (6 months)
  • Adequate renal function (serum creatinine \< 1.5 X UNL [upper normal limit] or creatinine clearance > 50 ml/min)
  • Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
  • Provide informed consent
  • Ability to complete patient booklet by themselves or with assistance
  • Ability and willingness to undergo >= 24-hour fast prior to chemotherapy
  • Willingness to be treated at Mayo Clinic Rochester and be available for follow-up
  • Patient willing to provide blood samples for correlative research purposes

Exclusion criteria

Exclusion Criteria:

  • Any of the following:

    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study period
  • Diabetes mellitus undergoing therapy with insulin or oral agents
  • History of low serum glucose (hypoglycemia) or insulinoma
  • History of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous
  • On daily medication that may not be safely taken without food; NOTE: Any non-essential medications and herbal/vitamin supplements should be held to minimize stomach upset during fasting; vitamin C use is discouraged
  • Active gastric or duodenal peptic ulcer disease
  • History of significant cardiac disease, particularly uncompensated congestive heart failure New York Heart Association (NYHA) grade 2 or more or left ventricular ejection fraction (LVEF) \< 40% on any prior assessment; NOTE: Assessment of LVEF prior to therapy is not required in the absence of other clinical indicators of heart disease
  • Recent history (\< 6 months) of cerebrovascular accident or transient ischemic attacks
  • History of gout or elevated uric acid level
  • Psychiatric conditions that preclude adherence to study protocol
  • Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled or whose control may potentially be jeopardized by the complications of fasting
  • Patients receiving parenteral nutrition
  • Receiving steroids (except dexamethasone given for nausea prevention before chemotherapy)
  • Patients receiving taxotere-containing chemotherapy regimens requiring pre-treatment steroid administration
  • Receiving concomitant treatment with insulin-like growth factor (IGF)-receptor blockers or monoclonal antibodies targeting the IGF ligands
  • Any of the following (prior to registration):

    • =\< 7 days from the time of a minor surgery;
    • =\< 21 days from the time of major surgery;
    • =\< 21 days from the time of radiation therapy
  • Currently enrolled in a concomitant clinical trial
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Short-term fasting prior to systemic chemotherapy

    COHORT I: Patients fast 24 hours before day 1 of course 2 of chemotherapy. If fast is well tolerated, patients may escalate fasting by 12 hours for each subsequent course of chemotherapy for up to 3 courses in the absence of unacceptable toxicity. COHORT II: Patients fast at the longest fasting regimen found to be safe and tolerable in cohort I before day 1 of each course of course of chemotherapy for up to 4 courses in the absence of unacceptable toxicity.

    Other: questionnaire administration · Other: preventative dietary intervention · Other: laboratory biomarker analysis

Interventions

  • Otherquestionnaire administration

    Ancillary studies: Pre- and post-fasting side effect questionnaires

  • Otherpreventative dietary intervention

    24, 36, or 48 hour fast prior to chemotherapy

    Also known as: preventative intervention, dietary

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications)

    Time frame: Up to 48 hours

  2. Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period

    Time frame: Up to 48 hours

  3. Percentage of patients able to achieve designated fasting regimen (i.e., greater than or equal to 50%)

    Time frame: Up to 48 hours

Secondary outcomes

  1. Weight changes in patients who are exposed to short-term fasting prior to chemotherapy

    Descriptive statistics will be applied to summarize weight changes from baseline for each subsequent course.

    Time frame: Baseline and 4 months

  2. Frequency and percentage of the longest feasible fasting period prior to chemotherapy

    Time frame: 4 months

  3. Overall toxicity incidence and profiles by fasting time and patient as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0

    Analyzed by frequency distributions, graphical techniques, and other descriptive measures.

    Time frame: 4 months

  4. Change in toxicity as assessed by Side Effect Questionnaire and descriptive statistics

    Assessing symptoms (with 0 being not at all and 10 being as bad as it can be), fasting difficulty (with 0 being very easy and 10 being extremely difficult), and willingness (with 0 being very willing and 10 being not willing at all).

    Time frame: Baseline and 4 months

  5. Changes in levels of plasma glucose, insulin, IGF-1 and IGF-1BP in subjects who undertake short-term fasting by descriptive statistics

    Time frame: Baseline and 4 months

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01175837
Lead sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 5, 2010
Start date
Aug 13, 2010
Primary completion
May 2, 2013
Completion
Dec 10, 2018
Last update
Dec 12, 2018

Study contacts

Charles Loprinzi
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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