Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

Study Overview
=================
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.

Official Title
-----------------
Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study

Conditions
-----------------
Malignant Neoplasm

Intervention / Treatment
-----------------
* Other: questionnaire administration
* Other: preventative dietary intervention
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short-term fasting prior to systemic chemotherapy<br>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<br>* Ancillary studies: Pre- and post-fasting side effect questionnaires<br>Other: preventative dietary intervention<br>* 24, 36, or 48 hour fast prior to chemotherapy<br>* Other names: preventative intervention, dietary;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications) |  | Up to 48 hours | 
| Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 4 months | 
| Frequency and percentage of the longest feasible fasting period prior to chemotherapy |  | 4 months | 
| 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. | 4 months | 
| 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). | Baseline and 4 months | 
| 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 |