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

Description

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

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Study Overview

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Study Details

Study overview

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.

A Randomized, Phase II Clinical Trial of Time-Restricted Eating Versus Nutritional Counseling in Cancer Patients Receiving Radiation or Chemoradiation to Evaluate Its Impact on Toxicity and Efficacy

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

Condition
Localized Prostate Carcinoma
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Medical Center, Duarte, California, United States, 91010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male and female patients aged 18 or older
  • * Localized high risk prostate cancer or node positive prostate cancer histologically confirmed by biopsy or recurrence after surgical resection planning to receive whole pelvis radiation therapy +/- androgen deprivation therapy or
  • * Locally advanced cervical cancer receiving whole pelvic/paraaortic radiation therapy + concurrent cisplatin-based chemotherapy or
  • * Locally advanced rectal cancer receiving whole pelvis radiation therapy + concurrent 5FU/capecitabine
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • * Able to provide a written consent for study participation
  • * PROSTATE CANCER: Prior radiation therapy to the prostate gland or pelvis
  • * PROSTATE CANCER: Prior therapy with androgen deprivation therapy for longer than 6 months
  • * PROSTATE CANCER: Prior chemotherapy
  • * PROSTATE CANCER: Men with diabetes may enroll, provided they are on stable doses of antihyperglycemic medication for at least 6 months and provided the physician managing their diabetes feels they can safely hold antihyperglycemic medication during daily time-restricted eating
  • * PROSTATE CANCER: Must be eligible to receive neoadjuvant and concurrent androgen deprivation therapy, but androgen deprivation therapy is not required
  • * PROSTATE CANCER: Men whose treatment plan includes up-front docetaxel will be excluded due potential confounding
  • * PROSTATE CANCER: Patients whose body mass index (BMI) is less than 21 at time of screening
  • * PROSTATE CANCER: Men who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carbohydrate (carb), paleolithic (paleo), or warrior diet are excluded
  • * GYNECOLOGIC CANCER: Prior radiation therapy to the cervix, uterus or pelvis
  • * GYNECOLOGIC CANCER: Prior chemotherapy
  • * GYNECOLOGIC CANCER: Women must not be pregnant, planning to become pregnant or lactating at the time of enrollment or during the course of the study
  • * GYNECOLOGIC CANCER: Women with diabetes may enroll, provided they are on stable doses of antihyperglycemic medication for at least 6 months and provided the physician managing their diabetes feels they can safely hold antihyperglycemic medication during daily time-restricted eating
  • * GYNECOLOGIC CANCER: Must be eligible to receive chemotherapy that is cisplatin based
  • * GYNECOLOGIC CANCER: Patients whose BMI is less than 21 at time of screening
  • * GYNECOLOGIC CANCER: Women who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carb, paleo, or warrior diet are excluded
  • * RECTAL CANCER: Prior pelvic radiation therapy
  • * RECTAL CANCER: Prior chemotherapy
  • * RECTAL CANCER: Patients with diabetes may enroll, provided they are on stable doses of antihyperglycemic medication for at least 6 months and provided the physician managing their diabetes feels they can safely hold antihyperglycemic medication during daily time-restricted eating
  • * RECTAL CANCER: Patients whose BMI is less than 21at time of screening
  • * RECTAL CANCER: Women must not be pregnant, planning to become pregnant or lactating at the time of enrollment or during the course of the study
  • * RECTAL CANCER: Patients who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carb, paleo, or warrior diet are excluded

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

City of Hope Medical Center,

Yun R Li, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

2026-07-20