Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
NCT ID: NCT05722288
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2023-01-20
2026-07-20
Brief Summary
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Detailed Description
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I. To test the hypothesis that time-restricted eating during radiation therapy (RT) or chemotherapy and radiation therapy (chemoRT) could reduce the level of accumulated double stranded deoxyribonucleic acid (dsDNA) damage in peripheral blood mononuclear cells (PBMCs) over the course of RT as measured by the gH2ax assay.
II. To examine if time-restricted eating during RT is associated with reduced toxicity as measured by clinician reported adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, improved patient quality of life as measured by European Organization for the Research and Treatment of Cancer Quality of Life (EORTC-PR25) (prostate cancer) and EORTC-CR29 (rectal cancer), reduced dsDNA damage as measured by assay for 8-oxo-dG and persistent DNA damage in shed epithelial cells from the urinary tract, reduced oxidative DNA damage as measured by reduced cumulative 8-oxoguanine DNA adducts, impacts the diversity of microbiome in relation and development of radiation induced microbiota dysbiosis and metabolic impact using liquid chromatography mass spectrometry (LC/MS) metabolomic analysis and correlative serological markers including IGF-1.0).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: 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.
ARM II: Patients receive nutritional counseling on study. Patients also undergo collection of blood throughout the trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (time-restricted eating)
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.
Biospecimen Collection
Undergo collection of blood
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Short-Term Fasting
Undergo time-restricted eating
Arm II (nutritional counseling)
Patients receive nutritional counseling on study. Patients also undergo collection of blood throughout the trial.
Biospecimen Collection
Undergo collection of blood
Informational Intervention
Receive nutritional counseling
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of blood
Informational Intervention
Receive nutritional counseling
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Short-Term Fasting
Undergo time-restricted eating
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Yun R Li
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2023-00238
Identifier Type: REGISTRY
Identifier Source: secondary_id
21709
Identifier Type: OTHER
Identifier Source: secondary_id
21709
Identifier Type: -
Identifier Source: org_study_id
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