A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy

Medical Oncology Clinical Trial

Official title:

A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359848
• Other study ID #: STUDY00005648
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This pilot trial will provide preliminary evidence that 1) intermittent caloric restriction and a plant-based diet is feasible in cancer patients; 2) intermittent caloric restriction and a plant-based diet can be safely combined with standard chemotherapy; and 3) intermittent caloric restriction and a plant-based diet may reduce the side effects but increase the antitumor effects of standard chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2025
• Est. primary completion date: December 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medical Nutrition Therapy
• Medical Oncology
• Neoplasms

Intervention

Other:
• Diet
Using dietary interventions as an adjuvant tool may represent an effective step toward advancing the treatment options of cancer. Dietary modifications can impact the growth and proliferation of tumors via multiple mechanisms

Locations

Country	Name	City	State
United States	University at Buffalo / Great Lakes Cancer Care	Buffalo	New York
United States	University at Buffalo / Great Lakes Cancer Care	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The safety and tolerability of the combination of chemotherapy and caloric restriction	assessed using NCI CTCAE	12 Months
Primary	The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy	enrollment rate	12 Months
Primary	The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy	drop-out rate	12 Months
Primary	The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy	compliance with diet measured by self-reports	12 Months
Secondary	To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction	objective response rate (partial + complete response)	12 Months
Secondary	To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction	progression-free survival (PFS)	12 Months
Secondary	To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction	overall survival (OS)	12 Months