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

NCT05722288 | Recruiting Phase 2 DMC

• 3 other identifiers: 21709NCI-2023-00238P30CA033572
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• Cumulative double strand deoxyribonucleic acid (dsDNA) damage of normal tissue

  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.

  Up to 1 year after radiation therapy/chemotherapy and radiation therapy (chemoRT)

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

  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.

  Up to 4 weeks

Secondary Outcomes (5)

• Rates of objective clinical adverse events (AEs)

  Up to 6 months

• Quality of life (QoL) indices - PR25

  Up to 1 year after completion of RT/chemoRT

• Quality of life (QoL) indices - CR29

  Up to 1 year after completion of RT/chemoRT

• Accumulated gH2ax foci

  Up to 1 year after completion of RT/chemoRT

• Oxidative DNA damage

  Up to 1 year after completion of RT/chemoRT

Study Arms (2)

Arm I (time-restricted eating)

EXPERIMENTAL

Patients undergo time-restricted eating Monday through Friday only of each week on study during standard RT or chemoRT. Patients also undergo collection of blood throughout the trial.

Procedure: Biospecimen Collection; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Short-Term Fasting

Arm II (nutritional counseling)

ACTIVE COMPARATOR

Patients receive nutritional counseling on study. Patients also undergo collection of blood throughout the trial.

Procedure: Biospecimen Collection; Other: Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Short-Term Fasting BEHAVIORAL

Undergo time-restricted eating

Also known as: Intermittent Fasting, Short-term Intermittent Fasting

Arm I (time-restricted eating)

Biospecimen Collection PROCEDURE

Undergo collection of blood

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (time-restricted eating); Arm II (nutritional counseling)

Informational Intervention OTHER

Receive nutritional counseling

Arm II (nutritional counseling)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (time-restricted eating); Arm II (nutritional counseling)

Questionnaire Administration OTHER

Ancillary studies

Arm I (time-restricted eating); Arm II (nutritional counseling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Rectal Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Yun R Li

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 10, 2023
• Study Start: January 20, 2023
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

US (1)