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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
No Placebo-Only Group
Summary
This trial studies if time-restricted eating can reduce side effects of radiation or chemoradiation in patients with prostate, cervical, and rectal cancers. It compares fasting periods to nutritional counseling to see which helps more with treatment side effects and overall health.
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.
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.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative double strand deoxyribonucleic acid (dsDNA) damage of normal tissue
Percentage of patients completing 4 weeks of time-restricted eating during RT
Secondary study objectives
Accumulated gH2ax foci
Oxidative DNA damage
Quality of life (QoL) indices - CR29
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~2020
Short-Term Fasting
2021
N/A
~50
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include androgen deprivation therapy (ADT) and radiation therapy. ADT lowers testosterone levels, which prostate cancer cells rely on for growth, thereby slowing disease progression.
Radiation therapy destroys cancer cells by damaging their DNA. Emerging strategies like time-restricted eating, which alternates between fasting and non-fasting periods, may enhance the efficacy of radiation therapy and reduce its side effects by improving metabolic health and reducing inflammation.
These mechanisms are important as they can potentially improve treatment outcomes and quality of life for prostate cancer patients.
Nutrition therapy with high intensity interval training to improve prostate cancer-related fatigue in men on androgen deprivation therapy: a study protocol.
Nutrition therapy with high intensity interval training to improve prostate cancer-related fatigue in men on androgen deprivation therapy: a study protocol.
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
598 Previous Clinical Trials
1,923,316 Total Patients Enrolled
15 Trials studying Prostate Cancer
5,633 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,879 Previous Clinical Trials
41,013,186 Total Patients Enrolled
569 Trials studying Prostate Cancer
529,860 Patients Enrolled for Prostate Cancer
Yun R LiPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is under 21 and I have gynecologic cancer.I am a man with prostate cancer not planning to start with docetaxel treatment.I have had radiation therapy in the pelvic area before.I have prostate cancer and stable diabetes, managed with medication for 6+ months.I am not on a strict diet like keto, low-carb, paleo, or warrior.I have had radiation therapy to my cervix, uterus, or pelvis.I have had chemotherapy for gynecologic cancer.I am eligible for chemotherapy that includes cisplatin for my gynecologic cancer.I have had chemotherapy for prostate cancer.I am not pregnant, planning to become pregnant, or breastfeeding.My BMI is under 21 and I have rectal cancer.My BMI is below 21 and I have prostate cancer.I can have hormone therapy for my prostate cancer, but it's not mandatory.I have been on hormone therapy for my prostate cancer for over 6 months.I am 18 or older with advanced rectal cancer getting radiation and chemotherapy.I have had chemotherapy for rectal cancer before.I have had radiation therapy to my prostate or pelvic area.I am 18 or older with high-risk or node-positive prostate cancer, confirmed by biopsy, planning to receive radiation therapy.I am able to care for myself and perform daily activities.I have rectal cancer and stable diabetes, with my doctor's approval to adjust my diabetes medication.I am 18 or older with advanced cervical cancer getting radiation and cisplatin chemotherapy.I am not pregnant, planning to become pregnant, or breastfeeding.I have gynecologic cancer and stable diabetes managed with medication for 6+ months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (time-restricted eating)
- Group 2: Arm II (nutritional counseling)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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