Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
NCT ID: NCT01175837
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2010-08-13
2018-12-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Short-term fasting prior to systemic chemotherapy
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.
questionnaire administration
Ancillary studies: Pre- and post-fasting side effect questionnaires
preventative dietary intervention
24, 36, or 48 hour fast prior to chemotherapy
laboratory biomarker analysis
Correlative studies
Interventions
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questionnaire administration
Ancillary studies: Pre- and post-fasting side effect questionnaires
preventative dietary intervention
24, 36, or 48 hour fast prior to chemotherapy
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Charles Loprinzi
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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NCI-2010-01572
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC09C3
Identifier Type: OTHER
Identifier Source: secondary_id
MC09C3
Identifier Type: -
Identifier Source: org_study_id