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

Official record

Identifier

NCT05722288

Recruiting locations

country

United States

Interventions studied

Biospecimen CollectionInformational InterventionQuality-of-Life AssessmentQuestionnaire AdministrationShort-Term Fasting

Lead sponsor

City of Hope Medical Center

Target enrolment

49 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Active, not recruiting

First posted

Feb 10, 2023

Last updated on the registry

Aug 13, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion 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

Exclusion Criteria:

* 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

Indexed under

Colorectal Cancer