Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers

Summary

This phase II trial studies how well time-restricted eating works in reducing side effects of radiation or chemoradiation side effects when compared to nutritional counseling among patients with prostate, cervical, and rectal cancers. Time-restricted eating, also called short term fasting or intermittent fasting, is an eating plan that alternates between not eating food (fasting) and non-fasting periods. Nutritional counseling involves being asked to follow a healthy, balanced diet that includes instructions on what kinds of food are better tolerated during radiation and chemoradiation therapy. This trial may help researchers determine if certain diets may improve the anti-cancer effects of radiation therapy and reduce the side-effects of this treatment. If successful, these diets may be integrated into the future treatment of prostate, cervical, and rectal cancers.

Conditions

• Localized Prostate Carcinoma
• Locally Advanced Cervical Carcinoma
• Locally Advanced Rectal Carcinoma
• Malignant Solid Neoplasm
• Recurrent Prostate Carcinoma
• Stage I Prostate Cancer AJCC v8
• Stage IB Cervical Cancer FIGO 2018
• Stage IB2 Cervical Cancer FIGO 2018
• Stage II Prostate Cancer AJCC v8
• Stage II Rectal Cancer AJCC v8
• Stage IIA Cervical Cancer FIGO 2018
• Stage IIB Cervical Cancer FIGO 2018
• Stage III Prostate Cancer AJCC v8
• Stage III Rectal Cancer AJCC v8
• Stage IIIA Cervical Cancer FIGO 2018
• Stage IIIB Cervical Cancer FIGO 2018
• Stage IIIC Cervical Cancer FIGO 2018
• Stage IVA Prostate Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood

OTHER

Informational Intervention

Receive nutritional counseling

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

BEHAVIORAL

Short-Term Fasting

Undergo time-restricted eating

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Yun R Li · City of Hope Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-20

Primary Completion

2026-07-20

Completion

2026-07-20

Countries

• United States

Study Locations