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
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.
• 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