RecruitingPhase 2

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

United States60 participantsStarted 2023-01-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 t…

What they're measuring

Cumulative double strand deoxyribonucleic acid (dsDNA) damage of normal tissue

Timeframe: Up to 1 year after radiation therapy/chemotherapy and radiation therapy (chemoRT)

Percentage of patients completing 4 weeks of time-restricted eating during RT

Timeframe: Up to 4 weeks

Trial details

NCT IDNCT05722288

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-20