Clinical trial · Interventional
Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study
NCT01175837CI-TRIAL-00036103completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| preventative dietary intervention | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Short-term fasting prior to systemic chemotherapy
- description
- 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.
- interventionNames
- Other: questionnaire administration
- Other: preventative dietary intervention
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications)
- timeFrame
- Up to 48 hours
- measure
- Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Body mass index (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 Criteria: * 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 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): * =\< 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
References
Publications (0)
Data not yet available
No reference posted for this study.