Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Lymphoma
Both
Lymphoma
Trial Information
Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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)
Outcome Time Frame:
At 24, 36, and 48 hours
Safety Issue:
Yes
Principal Investigator
Roxana S Dronca, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Institutional Review Board
Study ID:
MC09C3
NCT ID:
NCT01175837
Start Date:
August 2010
Completion Date:
Related Keywords:
- Lymphoma
- 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
- contiguous stage II mantle cell lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- cutaneous B-cell non-Hodgkin lymphoma
- de novo myelodysplastic syndromes
- essential thrombocythemia
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- intraocular lymphoma
- isolated plasmacytoma of bone
- mast cell leukemia
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- nodal marginal zone B-cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- polycythemia vera
- post-transplant lymphoproliferative disorder
- previously treated myelodysplastic syndromes
- primary myelofibrosis
- primary systemic amyloidosis
- progressive hairy cell leukemia, initial treatment
- prolymphocytic leukemia
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- recurrent adult Hodgkin lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult T-cell leukemia/lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- recurrent small lymphocytic lymphoma
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- secondary myelodysplastic syndromes
- splenic marginal zone lymphoma
- stage 0 chronic lymphocytic leukemia
- stage I adult Burkitt lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult Hodgkin lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I adult T-cell leukemia/lymphoma
- stage I chronic lymphocytic leukemia
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I mantle cell lymphoma
- stage I marginal zone lymphoma
- stage I multiple myeloma
- stage I mycosis fungoides/Sezary syndrome
- stage I small lymphocytic lymphoma
- stage II adult Hodgkin lymphoma
- stage II adult T-cell leukemia/lymphoma
- stage II chronic lymphocytic leukemia
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage II multiple myeloma
- stage II mycosis fungoides/Sezary syndrome
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage III chronic lymphocytic leukemia
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III multiple myeloma
- stage III mycosis fungoides/Sezary syndrome
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult T-cell leukemia/lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV mycosis fungoides/Sezary syndrome
- stage IV small lymphocytic lymphoma
- T-cell large granular lymphocyte leukemia
- untreated adult acute lymphoblastic leukemia
- untreated adult acute myeloid leukemia
- untreated hairy cell leukemia
- Waldenstrom macroglobulinemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
