Actively Recruiting
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
Led by City of Hope Medical Center · Updated on 2025-08-29
60
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 or older
- Histologically confirmed localized high risk or node positive prostate cancer or recurrence after surgery planning whole pelvis radiation therapy with or without androgen deprivation therapy
- Locally advanced cervical cancer receiving whole pelvic/paraaortic radiation therapy with concurrent cisplatin-based chemotherapy
- Locally advanced rectal cancer receiving whole pelvis radiation therapy with concurrent 5FU or capecitabine
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Able to provide written consent for study participation
You will not qualify if you...
- Prior radiation therapy to the prostate gland, pelvis, cervix, uterus, or pelvis depending on cancer type
- Prior chemotherapy for prostate, gynecologic, or rectal cancer
- Prior androgen deprivation therapy longer than 6 months for prostate cancer
- Men with diabetes must be on stable antihyperglycemic medication for at least 6 months and able to safely hold medication during time-restricted eating
- Must be eligible to receive neoadjuvant and concurrent androgen deprivation therapy for prostate cancer (not required to receive it)
- Men planned for up-front docetaxel treatment are excluded
- Body mass index (BMI) less than 21 at screening
- Current strict macronutrient or time-limited diet including ketogenic, low-carbohydrate, paleolithic, or warrior diet
- Women must not be pregnant, planning pregnancy, or lactating during enrollment or study
- Women with gynecologic cancer must be eligible for cisplatin-based chemotherapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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