Status:
COMPLETED
Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01175837
Start Date
August 13 2010
End Date
December 10 2018
Last Update
December 12 2018
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905