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Time-Restricted Eating vs. Nutritional Counseling for Cancer Treatment Side Effects

This study is looking at how time-restricted eating (also called short-term fasting) compares to nutritional counseling in reducing side effects from radiation or chemoradiation therapy. It's for patients with prostate, cervical, or rectal cancers. Time-restricted eating involves alternating between periods of not eating and eating, while nutritional counseling provides guidance on healthy eating during treatment. Researchers want to see if either approach can lessen treatment side effects and potentially improve the anti-cancer effects of radiation therapy. The study will measure changes in DNA damage in normal tissues and how many patients can stick to the time-restricted eating plan for four weeks. This trial is currently recruiting about 49 participants.

Study design
This is an interventional study with an unclear status, planning to enroll 49 participants. It compares two different approaches: time-restricted eating and nutritional counseling.
What's involved
Participants will undergo blood collection, receive either nutritional counseling or participate in short-term fasting, and complete quality-of-life and other questionnaires. The study will measure outcomes for up to 1 year after radiation therapy/chemotherapy and radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 1 year after their radiation therapy or chemoradiation therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalSupportive care
City of Hope Medical Center
~49 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Biospecimen CollectionInformational InterventionQuality-of-Life AssessmentQuestionnaire AdministrationShort-Term Fasting

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cumulative double strand deoxyribonucleic acid (dsDNA) damage of normal tissue
Measured over Up to 1 year after radiation therapy/chemotherapy and radiation therapy (chemoRT)
+1 more outcome measured

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

Explore related trials

Cervical CarcinomaProstate CarcinomaRectal Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Yun R Li · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Cumulative double strand deoxyribonucleic acid (dsDNA) damage of normal tissueUp to 1 year after radiation therapy/chemotherapy and radiation therapy (chemoRT)

    Will be measured by the gH2ax assay. The study population will be described by, and randomized groups compared with respect to baseline characteristics including demographics (age, race/ethnicity, education, gender for rectal cancer), clinical characteristics (prostate: pre-treatment prostate-specific antigen \[PSA\], National Comprehensive Cancer Network \[NCCN\] staging and rectal: American Joint Committee on Cancer version 8 \[AJCC8\] staging), and metabolic features (diabetes, HbA1c, waist circumference, fat mass, lipids). Given the potential for differential outcomes among diabetics, the analysis of trial outcomes will also include diabetes as a covariate.

  • Percentage of patients completing 4 weeks of time-restricted eating during RTUp to 4 weeks

    Feasibility and tolerability is pre-determined to be met if least 70% of patients randomized to time-restricted eating can complete at 4 weeks of time-restricted eating during their radiation course. Will be assessed through quarterly assessments of missing data points. The study dietician will track and report on compliance in the intervention (time-restricted eating) arm, and research coordinator will track and report accrual, screen failures, self-reporting survey completions and data entry metrics. Trouble areas will be discussed, and protocol amendments developed accordingly. The co-principal investigators (PIs) will review and determine whether feasibility of analysis is impacted and whether corrective measures can be implemented to improve data completeness.