Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01175837
First received: July 14, 2010
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Malignant Neoplasm
Other: questionnaire administration
Other: preventative dietary intervention
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period [ Time Frame: Up to 48 hours ] [ Designated as safety issue: Yes ]
  • Percentage of patients able to achieve designated fasting regimen (i.e., greater than or equal to 50%) [ Time Frame: Up to 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Weight changes in patients who are exposed to short-term fasting prior to chemotherapy [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2010
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175837

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Charles Loprinzi Mayo Clinic
  More Information

No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01175837     History of Changes
Other Study ID Numbers: MC09C3, NCI-2010-01572, MC09C3, P30CA015083
Study First Received: July 14, 2010
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014