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Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study


N/A
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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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 ClinicRochester, Minnesota  55905