Comparing time-restricted eating and nutritional counseling for reducing cancer treatment side effects
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
PHASE2 · City of Hope Medical Center · NCT05722288
This study is testing if time-restricted eating can help reduce side effects from cancer treatments in patients with prostate, cervical, and rectal cancers compared to those who receive nutritional counseling.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT05722288 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of time-restricted eating in reducing side effects associated with radiation or chemoradiation therapy in patients with prostate, cervical, and rectal cancers. Participants are randomized into two groups: one follows a time-restricted eating regimen while the other receives nutritional counseling. The study aims to measure various outcomes, including DNA damage, toxicity levels, and quality of life, using established clinical and laboratory assessments. The goal is to determine if dietary interventions can enhance the efficacy of cancer treatments and mitigate adverse effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with localized high-risk prostate cancer, locally advanced cervical cancer, or locally advanced rectal cancer who are scheduled for radiation therapy.
Not a fit: Patients who have previously undergone radiation therapy to the prostate or pelvis, or those with certain prior treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the side effects of cancer treatments, improving patient quality of life.
How similar studies have performed: While the concept of time-restricted eating is gaining attention, this specific application in the context of cancer treatment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (RECRUITING)
Study contacts
- Principal investigator: Yun R Li — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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