Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

Completed · Not applicable

Conditions studied: Malignant Neoplasm

In brief

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.

Key facts

Study ID

NCT01175837

Run by

Mayo Clinic

People needed

12

Starts

2010-08-13

Expected to finish

2018-12-10

Last updated by the study team

2018-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.