Clinical trial NCT01175837: Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
Official title: Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications)
timeFrame: Up to 48 hours
measure: Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period
timeFrame: Up to 48 hours
measure: Percentage of patients able to achieve designated fasting regimen (i.e., greater than or equal to 50%)
timeFrame: Up to 48 hours
Secondary outcomes:
measure: Weight changes in patients who are exposed to short-term fasting prior to chemotherapy
timeFrame: Baseline and 4 months
measure: Frequency and percentage of the longest feasible fasting period prior to chemotherapy
timeFrame: 4 months
measure: Overall toxicity incidence and profiles by fasting time and patient as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
timeFrame: 4 months
measure: Change in toxicity as assessed by Side Effect Questionnaire and descriptive statistics
timeFrame: Baseline and 4 months
measure: Changes in levels of plasma glucose, insulin, IGF-1 and IGF-1BP in subjects who undertake short-term fasting by descriptive statistics
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Charles Loprinzi
role: PRINCIPAL_INVESTIGATOR
References: