Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

• ClinicalTrials.gov Identifier: NCT01175837
• Recruitment Status: Completed
• First Posted: August 5, 2010
• Last Update Posted: December 12, 2018
• Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Mayo Clinic

Tracking Information

• First Submitted Date: July 14, 2010
• First Posted Date: August 5, 2010
• Last Update Posted Date: December 12, 2018
• Actual Study Start Date: August 13, 2010
• Actual Primary Completion Date: May 2, 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Malignant Neoplasm

Intervention

• 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

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: August 3, 2010): 12
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 10, 2018
• Actual Primary Completion Date: May 2, 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01175837
• Other Study ID Numbers: 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
• Current Responsible Party: Mayo Clinic
• Original Responsible Party: Loprinzi, Charles, Mayo Clinic Rochester
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Charles Loprinzi; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: December 2018