Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

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) is a Phase 2 interventional studying Localized Prostate Carcinoma and Locally Advanced Cervical Carcinoma, sponsored by City of Hope Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Localized Prostate Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Localized Prostate Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Male and female patients aged 18 or older - Localized high risk prostate cancer or node positive prostate cancer diagnosed by tissue sample (biopsy-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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

Biospecimen Collection

Undergo collection of blood

OTHER

Informational Intervention

Receive nutritional counseling

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

BEHAVIORAL

Short-Term Fasting

Undergo time-restricted eating

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

City of Hope Medical Center

Duarte, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05722288), the sponsor (City of Hope Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05722288 clinical trial studying?

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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05722288?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05722288?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05722288. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05722288. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.