Clinical trial · Interventional
A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy
A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy
NCT05359848CI-TRIAL-00103748recruitingN/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)
Caloric restriction may alter the response to chemotherapy induced stress response and enhance its antitumor effect. This study intends to use an intermitted caloric restriction protocol with alternate days before the chemotherapy administration to enhance the cytotoxic effect generated by standard treatment of cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Integrative Oncology | — | UNRESOLVED | — |
| Medical Nutrition Therapy | — | UNRESOLVED | — |
| Medical Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
- timeFrame
- 12 Months
- description
- enrollment rate
- measure
- The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
- timeFrame
- 12 Months
- description
- drop-out rate
- measure
- The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy
- timeFrame
- 12 Months
- description
- compliance with diet measured by self-reports
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* • Histologically documented, cancer patients who are eligible to receive cytotoxic chemotherapy.
* Life expectancy of at least 6 months
* Adults ≥ 18 years of age
* Adequate hematologic, renal, and liver function as evidenced by the following:
* White blood cell (WBC) ≥ 2,500 cells/μL
* Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
* Platelet Count ≥ 100,000 cells/μL
* Hemoglobin (HgB) ≥ 9.0 g/dL
* Creatinine ≤ 2.0 mg/dL
* Total bilirubin ≤ 2 x upper limit of normal (ULN)
* Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
* Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN
Exclusion Criteria:
* • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
* Treatment with any of the following medications or interventions within 28 days of registration:
* Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
* High dose calcitriol \[1,25(OH)2VitD\] (i.e., \> 7.0 μg/week)
* Any infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5°F or 38.1°C) within 1 week prior to registration
* A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT/MRI imaging
* Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectivesReferences
Publications (0)
Data not yet available
No reference posted for this study.