Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

Tracking Information
First Submitted Date ICMJE	July 14, 2010
First Posted Date ICMJE	August 5, 2010
Last Update Posted Date	November 17, 2017
Actual Study Start Date ICMJE	August 2010
Estimated Primary Completion Date	August 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 5, 2014)	Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications) [ Time Frame: Up to 48 hours ]; Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period [ Time Frame: Up to 48 hours ]; Percentage of patients able to achieve designated fasting regimen (i.e., greater than or equal to 50%) [ Time Frame: Up to 48 hours ]
Original Primary Outcome Measures ICMJE; (submitted: August 3, 2010)	Safety and feasibility of short-term fasting prior to administration of chemotherapy as assessed by number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications) [ Time Frame: At 24, 36, and 48 hours ]; Safety and feasibility of short-term fasting prior to administration of chemotherapy as assessed by number of patients experiencing >= grade 3 adverse event related to the fasting period [ Time Frame: At 24, 36, and 48 hours ]; Safety and feasibility of short-term fasting prior to administration of chemotherapy as assessed by percentage of patients able to achieve designated fasting regimen (i.e., >= 50%) [ Time Frame: At 24, 36, and 48 hours ]
Change History	Complete list of historical versions of study NCT01175837 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 5, 2014)	Weight changes in patients who are exposed to short-term fasting prior to chemotherapy [ Time Frame: Baseline and 4 months ]Descriptive statistics will be applied to summarize weight changes from baseline for each subsequent course.; Frequency and percentage of the longest feasible fasting period prior to chemotherapy [ Time Frame: 4 months ]; Overall toxicity incidence and profiles by fasting time and patient as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: 4 months ]Analyzed by frequency distributions, graphical techniques, and other descriptive measures.; Change in toxicity as assessed by Side Effect Questionnaire and descriptive statistics [ Time Frame: Baseline and 4 months ]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).; Changes in levels of plasma glucose, insulin, IGF-1 and IGF-1BP in subjects who undertake short-term fasting by descriptive statistics [ Time Frame: Baseline and 4 months ]
Original Secondary Outcome Measures ICMJE; (submitted: August 3, 2010)	Weight changes in patients [ Time Frame: 4 months ]; Longest feasible fasting period prior to chemotherapy as defined by safety and feasibility criteria; Toxicity profile of systemic chemotherapy treatment as defined by adverse events per CTCAE v4.0 and by patient side effect questionnaire; Changes in levels of plasma glucose, insulin, IGF-1 and IGF-1BP [ Time Frame: 4 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
Official Title ICMJE	Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
Condition ICMJE	Malignant Neoplasm
Intervention ICMJE	Other: questionnaire administration Ancillary studies: Pre- and post-fasting side effect questionnaires; Other: preventative dietary intervention 24, 36, or 48 hour fast prior to chemotherapy Other Name: preventative intervention, dietary; Other: laboratory biomarker analysis Correlative studies
Study Arms	Experimental: 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.; Interventions: Other: questionnaire administration; Other: preventative dietary intervention; Other: laboratory biomarker analysis
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Estimated Enrollment ICMJE; (submitted: August 3, 2010)	12
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	August 2018
Estimated Primary Completion Date	August 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01175837
Other Study ID Numbers ICMJE	MC09C3; NCI-2010-01572 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); MC09C3 ( Other Identifier: Mayo Clinic ); P30CA015083 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Mayo Clinic
Study Sponsor ICMJE	Mayo Clinic
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: Charles Loprinzi Mayo Clinic
PRS Account	Mayo Clinic
Verification Date	November 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP