Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

NCT01175837 | Completed

• 3 other identifiers: MC09C3NCI-2010-01572P30CA015083
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (3)

• Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications)

  Up to 48 hours

• Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period

  Up to 48 hours

• Percentage of patients able to achieve designated fasting regimen (i.e., greater than or equal to 50%)

  Up to 48 hours

Secondary Outcomes (5)

• Weight changes in patients who are exposed to short-term fasting prior to chemotherapy

  Baseline and 4 months

• Frequency and percentage of the longest feasible fasting period prior to chemotherapy

  4 months

• Overall toxicity incidence and profiles by fasting time and patient as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  4 months

• Change in toxicity as assessed by Side Effect Questionnaire and descriptive statistics

  Baseline and 4 months

• Changes in levels of plasma glucose, insulin, IGF-1 and IGF-1BP in subjects who undertake short-term fasting by descriptive statistics

  Baseline and 4 months

Study Arms (1)

Short-term fasting prior to systemic chemotherapy

EXPERIMENTAL

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; Other: preventative dietary intervention; Other: laboratory biomarker analysis

Interventions

questionnaire administration OTHER

Ancillary studies: Pre- and post-fasting side effect questionnaires

Short-term fasting prior to systemic chemotherapy

preventative dietary intervention OTHER

24, 36, or 48 hour fast prior to chemotherapy

Also known as: preventative intervention, dietary

Short-term fasting prior to systemic chemotherapy

laboratory biomarker analysis OTHER

Correlative studies

Short-term fasting prior to systemic chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Charles Loprinzi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: August 5, 2010
• Study Start: August 13, 2010
• Primary Completion: May 2, 2013
• Study Completion: December 10, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (1)