An interventional study of questionnaire administration and preventative dietary intervention in Malignant Neoplasm, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 12 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion Criteria:
Any of the following:
Any of the following (prior to registration):
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
Ancillary studies: Pre- and post-fasting side effect questionnaires
24, 36, or 48 hour fast prior to chemotherapy
Also known as: preventative intervention, dietary
Correlative studies
Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications)
Time frame: Up to 48 hours
Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period
Time frame: Up to 48 hours
Percentage of patients able to achieve designated fasting regimen (i.e., greater than or equal to 50%)
Time frame: Up to 48 hours
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.
Time frame: Baseline and 4 months
Frequency and percentage of the longest feasible fasting period prior to chemotherapy
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: Baseline and 4 months
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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