Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

Not Applicable

Completed

• Conditions: Malignant Neoplasm
• Interventions: Other: questionnaire administration; Other: preventative dietary intervention; Other: laboratory biomarker analysis

• Registration Number: NCT01175837
• Lead Sponsor: Mayo Clinic

Brief 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.

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.

Study Timeline

• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-05
• Study Start: 2010-08-13
• Primary Completion: 2013-05-02
• Status Verified: 2018-12
• Study Completion: 2018-12-10
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Short-term fasting prior to systemic chemotherapy	laboratory biomarker analysis	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.
Short-term fasting prior to systemic chemotherapy	questionnaire administration	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.
Short-term fasting prior to systemic chemotherapy	preventative dietary intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period	Up to 48 hours
Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications)	Up to 48 hours
Percentage of patients able to achieve designated fasting regimen (i.e., greater than or equal to 50%)	Up to 48 hours

Secondary Outcome Measures

Name	Time	Method
Overall toxicity incidence and profiles by fasting time and patient as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0	4 months	Analyzed by frequency distributions, graphical techniques, and other descriptive measures.
Changes in levels of plasma glucose, insulin, IGF-1 and IGF-1BP in subjects who undertake short-term fasting by descriptive statistics	Baseline and 4 months
Weight changes in patients who are exposed to short-term fasting prior to chemotherapy	Baseline and 4 months	Descriptive statistics will be applied to summarize weight changes from baseline for each subsequent course.
Change in toxicity as assessed by Side Effect Questionnaire and descriptive statistics	Baseline and 4 months	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).
Frequency and percentage of the longest feasible fasting period prior to chemotherapy	4 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States