Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

Mayo Clinic

Status: Completed

Conditions: Malignant Neoplasm

Treatments: Other: laboratory biomarker analysis; Other: preventative dietary intervention; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01175837

P30CA015083 (U.S. NIH Grant/Contract)

MC09C3 (Other Identifier)

NCI-2010-01572 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Short-term fasting prior to systemic chemotherapy

Experimental group

Description:

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.

Treatment:

Other: preventative dietary intervention

Other: questionnaire administration

Other: laboratory biomarker analysis