NCT05359848 A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy
| NCT ID | NCT05359848 |
| Status | Recruiting |
| Phase | — |
| Sponsor | State University of New York at Buffalo |
| Condition | Medical Oncology |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-04-15 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-04-15 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 objectives
Frequently Asked Questions
Who can join the NCT05359848 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Medical Oncology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05359848 currently recruiting?
Yes, NCT05359848 is actively recruiting participants. Visit ClinicalTrials.gov or contact State University of New York at Buffalo to inquire about joining.
Where is the NCT05359848 trial being conducted?
This trial is being conducted at Buffalo, United States, Buffalo, United States.
Who is sponsoring the NCT05359848 clinical trial?
NCT05359848 is sponsored by State University of New York at Buffalo. The trial plans to enroll 30 participants.