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Recruiting NCT05722288

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

Conditions: 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

Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 60
Sponsor: City of Hope Medical Center

Location: United States

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 Criteria

Inclusion Criteria:Male and female patients aged 18 or olderLocalized 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 orLocally advanced cervical cancer receiving whole pelvic/paraaortic radiation therapy + concurrent cisplatin-based chemotherapy orLocally advanced rectal cancer receiving whole pelvis radiation therapy + concurrent 5FU/capecitabineEastern Cooperative Oncology Group (ECOG) Performance Status 0-2Able to provide a written consent for study participationExclusion Criteria:PROSTATE CANCER: Prior radiation therapy to the prostate gland or pelvisPROSTATE CANCER: Prior therapy with androgen deprivation therapy for longer than 6 monthsPROSTATE CANCER: Prior chemotherapyPROSTATE 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 eatingPROSTATE CANCER: Must be eligible to receive neoadjuvant and concurrent androgen deprivation therapy, but androgen deprivation therapy is not requiredPROSTATE CANCER: Men whose treatment plan includes up-front docetaxel will be excluded due potential confoundingPROSTATE CANCER: Patients whose body mass index (BMI) is less than 21 at time of screeningPROSTATE CANCER: Men who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carbohydrate (carb), paleolithic (paleo), or warrior diet are excludedGYNECOLOGIC CANCER: Prior radiation therapy to the cervix, uterus or pelvisGYNECOLOGIC CANCER: Prior chemotherapyGYNECOLOGIC CANCER: Women must not be pregnant, planning to become pregnant or lactating at the time of enrollment or during the course of the studyGYNECOLOGIC 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 eatingGYNECOLOGIC CANCER: Must be eligible to receive chemotherapy that is cisplatin basedGYNECOLOGIC CANCER: Patients whose BMI is less than 21 at time of screeningGYNECOLOGIC CANCER: Women who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carb, paleo, or warrior diet are excludedRECTAL CANCER: Prior pelvic radiation therapyRECTAL CANCER: Prior chemotherapyRECTAL 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 eatingRECTAL CANCER: Patients whose BMI is less than 21at time of screeningRECTAL CANCER: Women must not be pregnant, planning to become pregnant or lactating at the time of enrollment or during the course of the studyRECTAL CANCER: Patients who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carb, paleo, or warrior diet are excluded

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05722288). StuddyBuddy aggregates publicly available trial information.