Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01572 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC09C3 | Other Identifier | Mayo Clinic | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | Ancillary studies: Pre- and post-fasting side effect questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight changes in patients who are exposed to short-term fasting prior to chemotherapy | Descriptive statistics will be applied to summarize weight changes from baseline for each subsequent course. | Baseline and 4 months |
| Frequency and percentage of the longest feasible fasting period prior to chemotherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any of the following:
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):
Currently enrolled in a concomitant clinical trial
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles Loprinzi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| preventative dietary intervention | Other | 24, 36, or 48 hour fast prior to chemotherapy |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| 4 months |
| Overall toxicity incidence and profiles by fasting time and patient as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Analyzed by frequency distributions, graphical techniques, and other descriptive measures. | 4 months |
| Change in toxicity as assessed by Side Effect Questionnaire and descriptive statistics | 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). | 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 |