RecruitingPhase 2NCT05722288

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

Sponsor

City of Hope Medical Center

Enrollment

60 participants

Start Date

Jan 20, 2023

Study Type

INTERVENTIONAL

Conditions

Malignant Solid Neoplasm Locally Advanced Cervical Carcinoma Recurrent Prostate Carcinoma Stage III Prostate Cancer AJCC v8 Localized Prostate Carcinoma Locally Advanced Rectal 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 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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether time-restricted eating (fasting for 16+ hours per day, eating only within a set window) can reduce the bowel and digestive side effects of radiation or chemoradiation in patients with prostate, cervical, or rectal cancer who require pelvic radiation therapy. **You may be eligible if...** - You are 18 or older with localized high-risk or node-positive prostate cancer, locally advanced cervical cancer, or locally advanced rectal cancer - You are scheduled for pelvic radiation therapy (with or without concurrent chemotherapy) - Your general health status is good enough for radiation (ECOG 0-2) **You may NOT be eligible if...** - You have had prior pelvic radiation for the same cancer type - You are pregnant, planning to become pregnant, or breastfeeding - You have already been on a strict dietary regimen (ketogenic, paleo, warrior diet, etc.) - Your BMI is below 21 (for prostate cancer patients) - You have had chemotherapy previously (for prostate or cervical cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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