← Back to Search

Time-Restricted Eating for Cancer Side Effect Reduction

Phase 2

Recruiting

Led By Yun R Li

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year after completion of rt/chemort

Awards & highlights

Study Summary

This trial compares the effectiveness of time-restricted eating and nutritional counseling in reducing side effects of radiation/chemoradiation for prostate, cervical and rectal cancers.

Who is the study for?

This trial is for adults with high-risk prostate, advanced rectal, or cervical cancer who are about to receive radiation or chemoradiation. They must be in good enough health to participate (ECOG 0-2) and not have had certain prior treatments like long-term hormone therapy for prostate cancer or any chemotherapy. Pregnant women, those planning pregnancy, lactating women, individuals on strict diets such as keto or paleo, and those with a BMI under 21 are excluded.Check my eligibility

What is being tested?

The study compares the effects of time-restricted eating (intermittent fasting) versus nutritional counseling on reducing side effects from radiation or chemoradiation treatment in patients with specific cancers. Researchers want to see if these dietary approaches can enhance the effectiveness of cancer treatments and lessen their adverse effects.See study design

What are the potential side effects?

While this trial focuses on diet's impact rather than drugs', potential side effects may include hunger during fasting periods, possible changes in blood sugar levels which could affect diabetics' medication needs, and general discomfort associated with altering one's eating patterns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after radiation therapy/chemotherapy and radiation therapy (chemort)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year after radiation therapy/chemotherapy and radiation therapy (chemort)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after radiation therapy/chemotherapy and radiation therapy (chemort) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Accumulated gH2ax foci

Oxidative DNA damage

Quality of life (QoL) indices - CR29

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (time-restricted eating)Experimental Treatment4 Interventions

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.

Group II: Arm II (nutritional counseling)Active Control4 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Short-Term Fasting

2021

N/A

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,400 Total Patients Enrolled

14 Trials studying Prostate Cancer

5,613 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,461 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

Yun R LiPrincipal InvestigatorCity of Hope Medical Center

Media Library

Nutritional Counseling Clinical Trial Eligibility Overview. Trial Name: NCT05722288 — Phase 2

Prostate Cancer Research Study Groups: Arm I (time-restricted eating), Arm II (nutritional counseling)

Prostate Cancer Clinical Trial 2023: Nutritional Counseling Highlights & Side Effects. Trial Name: NCT05722288 — Phase 2

Nutritional Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT05722288 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is time-restricted eating a viable option for sustained health outcomes?

"Our team has assigned the safety of Arm I (time-restricted eating) a rating of 2, as this is just a Phase 2 trial. There are some data points indicating its safety but none supporting its effectiveness."

Answered by AI

How many participants are currently partaking in this medical research?

"Affirmative. The information available on clinicaltrials.gov declares that this medical study, which was initial posted on January 20th of 2021, is actively recruiting. Approximately 60 patients need to be sourced from 1 site."

Answered by AI

Is this experiment recruiting participants at the moment?

"Affirmative, according to the information on clinicaltrials.gov this medical experiment is still looking for participants. This trial was posted at the start of January 2023 and most recently updated in early February 2021; it aims to enrol 60 patients from one location."

Answered by AI

What aims is this trial endeavoring to accomplish?

"The primary source of data for this clinical trial will be obtained over a period of one year after radiation and chemotherapy are administered. Outcome measurements include the percentage of participants completing four weeks of time-restricted eating, European Organization for the Research and Treatment of Cancer Quality Of Life Questionnaire Prostate (EORTC-QLQ PR25) results, European Organisation For The Research And Treatment Of Cancer Quality Of Life Questionnaire Colorectal (CR29) scores, along with accumulated gH2ax foci observed in patient's shed epithelial cells from their urinary tract and peripheral blood mononuclear cells. Adverse events will be"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05722288.

All > Recurrent Prostate Cancer