A Pilot, Feasibility Study of Intermittent Caloric Restri... | NCT05359848

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2022Actual

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Jun 1, 2027Estimated

First Submitted Date

Apr 25, 2022

First Submission Date that Met QC Criteria

Apr 28, 2022

First Posted Date

May 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2026

Last Update Posted Date

Feb 20, 2026Actual

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
Diet	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy	enrollment rate	12 Months
The feasibility of intermittent caloric restriction plus a plant-based diet in cancer patients receiving chemotherapy	drop-out rate	12 Months
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 Outcomes

Measure	Description	Time Frame
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction	objective response rate (partial + complete response)	12 Months
To obtain preliminary evidence of clinical efficacy of the combination of chemotherapy and intermittent caloric restriction

Other Outcomes

Measure	Description	Time Frame
The safety and tolerability of the combination of chemotherapy and caloric restriction	assessed using NCI CTCAE	12 Months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University at Buffalo / Great Lakes Cancer Care	Recruiting	Buffalo	New York	14203	United States

Intervention Model Description

Patients with cancer where SOC is represented by chemotherapy will be eligible for the study. After informed consent, eligible patients will be scheduled to the chemotherapy. Each cycle will be every 14, 21 or 28 days depending on the regimen. The diet intervention will commence 1 week prior to the first infusion (i.e. on Day -5 for regimens every 21-28 days, on Day-3 for regimens every 14 days) and will continue until the end of cycle 4 or 6 depending on the regimen in the neoadjuvant or adjuvant setting. For metastatic disease the dietary intervention will last until cycle 6 and not beyond

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena