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

Launched by CITY OF HOPE MEDICAL CENTER · Feb 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different approaches to help reduce the side effects that patients with prostate, cervical, or rectal cancers might experience during their radiation or chemoradiation treatments. One approach is called time-restricted eating, which involves eating only during certain hours of the day and fasting during the rest. The other approach is nutritional counseling, where patients receive guidance on maintaining a healthy diet that can help them tolerate their treatment better. By comparing these two methods, researchers hope to find out if specific eating patterns can enhance the effectiveness of cancer treatments and lessen side effects.

To participate in this trial, individuals must be 18 years or older and diagnosed with certain stages of prostate, cervical, or rectal cancer, specifically those who are about to start radiation therapy. Participants can expect to receive either dietary guidance on time-restricted eating or nutritional counseling throughout their treatment. It’s important to note that individuals with certain health conditions or those who have undergone specific previous treatments may not be eligible. This trial is currently recruiting participants, and if successful, it could lead to new dietary strategies integrated into cancer treatment plans in the future.

Gender

ALL

Eligibility criteria

• 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 than 21 at time of screening
• • 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
• • GYNECOLOGIC CANCER: Prior radiation therapy to the cervix, uterus or pelvis
• • GYNECOLOGIC CANCER: Prior chemotherapy
• • 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
• • 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
• • GYNECOLOGIC CANCER: Must be eligible to receive chemotherapy that is cisplatin based
• • GYNECOLOGIC CANCER: Patients whose BMI is less than 21 at time of screening
• • GYNECOLOGIC CANCER: Women who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carb, paleo, or warrior diet are excluded
• • RECTAL CANCER: Prior pelvic radiation therapy
• • RECTAL CANCER: Prior chemotherapy
• • 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
• • RECTAL CANCER: Patients whose BMI is less than 21at time of screening
• • 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
• • RECTAL CANCER: Patients who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carb, paleo, or warrior diet are excluded