RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-01-20
Study Completion:2026-07-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05722288

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female patients aged 18 or older
  2. * 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
  3. * Locally advanced cervical cancer receiving whole pelvic/paraaortic radiation therapy + concurrent cisplatin-based chemotherapy or
  4. * Locally advanced rectal cancer receiving whole pelvis radiation therapy + concurrent 5FU/capecitabine
  5. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  6. * Able to provide a written consent for study participation
  1. * PROSTATE CANCER: Prior radiation therapy to the prostate gland or pelvis
  2. * PROSTATE CANCER: Prior therapy with androgen deprivation therapy for longer than 6 months
  3. * PROSTATE CANCER: Prior chemotherapy
  4. * 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
  5. * PROSTATE CANCER: Must be eligible to receive neoadjuvant and concurrent androgen deprivation therapy, but androgen deprivation therapy is not required
  6. * PROSTATE CANCER: Men whose treatment plan includes up-front docetaxel will be excluded due potential confounding
  7. * PROSTATE CANCER: Patients whose body mass index (BMI) is less than 21 at time of screening
  8. * 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
  9. * GYNECOLOGIC CANCER: Prior radiation therapy to the cervix, uterus or pelvis
  10. * GYNECOLOGIC CANCER: Prior chemotherapy
  11. * 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
  12. * 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
  13. * GYNECOLOGIC CANCER: Must be eligible to receive chemotherapy that is cisplatin based
  14. * GYNECOLOGIC CANCER: Patients whose BMI is less than 21 at time of screening
  15. * GYNECOLOGIC CANCER: Women who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carb, paleo, or warrior diet are excluded
  16. * RECTAL CANCER: Prior pelvic radiation therapy
  17. * RECTAL CANCER: Prior chemotherapy
  18. * 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
  19. * RECTAL CANCER: Patients whose BMI is less than 21at time of screening
  20. * 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
  21. * RECTAL CANCER: Patients who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carb, paleo, or warrior diet are excluded

Contacts and Locations

Principal Investigator

Yun R Li
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Yun R Li, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-20
Study Completion Date2026-07-20

Study Record Updates

Study Start Date2023-01-20
Study Completion Date2026-07-20

Terms related to this study

Additional Relevant MeSH Terms

  • 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