Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

This study is currently recruiting participants.
Verified March 2014 by Mayo Clinic
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01175837
First received: July 14, 2010
Last updated: March 6, 2014
Last verified: March 2014

July 14, 2010
March 6, 2014
August 2010
December 2014   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01175837 on ClinicalTrials.gov Archive Site
  • Weight changes in patients [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Longest feasible fasting period prior to chemotherapy as defined by safety and feasibility criteria [ Designated as safety issue: No ]
  • Toxicity profile of systemic chemotherapy treatment as defined by adverse events per CTCAE v4.0 and by patient side effect questionnaire [ Designated as safety issue: Yes ]
  • Changes in levels of plasma glucose, insulin, IGF-1 and IGF-1BP [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study

RATIONALE: Fasting before chemotherapy may protect normal cells from the side effects of chemotherapy.

PURPOSE: This clinical trial studies short-term fasting before chemotherapy in treating patients with cancer.

PRIMARY OBJECTIVES:

I. To assess the safety and feasibility of short-term fasting prior to administration of chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate weight changes in patients who are exposed to short-term fasting prior to chemotherapy.

II. To get a preliminary estimate of the longest feasible fasting period prior to chemotherapy.

III. To evaluate the toxicity profile of systemic chemotherapy treatment in patients who undergo short-term fasting prior to treatment.

IV. To investigate changes in plasma glucose, insulin, IGF-1 and IGF-1BP 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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Lymphoma
  • Other: enzyme-linked immunosorbent assay
    Correlative studies
    Other Name: ELISA
  • Genetic: microarray analysis
    Correlative studies
    Other Name: gene expression profiling
  • 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
Experimental: Arm I
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: enzyme-linked immunosorbent assay
  • Genetic: microarray analysis
  • Other: questionnaire administration
  • Other: preventative dietary intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion

  • 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)
  • ECOG performance status 0 or 1
  • 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

  • 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 NYHA grade 2 or more or 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 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
Both
18 Years and older
No
Not Provided
United States
 
NCT01175837
MC09C3, NCI-2010-01572, 10-002451, MC09C3
Yes
Roxana S. Dronca, M.D., Mayo Clinic Cancer Center
Mayo Clinic
Not Provided
Study Chair: Roxana S Dronca, M.D. Mayo Clinic
Mayo Clinic
March 2014

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