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
  Purpose

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.


Condition Intervention
Lymphoma
Other: enzyme-linked immunosorbent assay
Genetic: microarray analysis
Other: questionnaire administration
Other: preventative dietary intervention

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:

Genetic and Rare Diseases Information Center resources: Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Lymphoma, Small Cleaved-cell, Diffuse Multiple Myeloma Chronic Myeloproliferative Disorders Acute Lymphoblastic Leukemia Hodgkin Lymphoma Waldenstrom Macroglobulinemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic/myeloproliferative Disease Acute Myeloid Leukemia, Adult Follicular Lymphoma B-cell Lymphomas Myelofibrosis Burkitt Lymphoma Lymphoma, Large-cell Lymphomatoid Granulomatosis Lymphoma, Large-cell, Immunoblastic Lymphoblastic Lymphoma Anaplastic Large Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Hypereosinophilic Syndrome Mantle Cell Lymphoma Cutaneous T-cell Lymphoma AL Amyloidosis Leukemia, T-cell, Chronic Essential Thrombocythemia Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hairy Cell Leukemia Mycosis Fungoides Sezary Syndrome Large Granular Lymphocyte Leukemia Anaplastic Plasmacytoma Polycythemia Vera Systemic Mastocytosis
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: August 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Office    507-538-7623      
Principal Investigator: Roxana S Dronca, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Roxana S Dronca, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Roxana S. Dronca, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT01175837     History of Changes
Other Study ID Numbers: MC09C3, NCI-2010-01572, 10-002451, MC09C3
Study First Received: July 14, 2010
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
unspecified adult solid tumor, protocol specific
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
atypical chronic myeloid leukemia, BCR-ABL negative
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult lymphoblastic lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 14, 2014