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Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01175837
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE July 14, 2010
First Posted Date  ICMJE August 5, 2010
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE August 13, 2010
Actual Primary Completion Date May 2, 2013   (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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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  ICMJE 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 Completed
Estimated Enrollment  ICMJE
 (submitted: August 3, 2010)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 10, 2018
Actual Primary Completion Date May 2, 2013   (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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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 December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP