What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as radiation therapy and androgen deprivation therapy (ADT), have several known side effects. Radiation therapy can cause fatigue, skin irritation, urinary problems, and bowel issues. ADT, often used alongside radiation, can lead to hot flashes, reduced libido, erectile dysfunction, bone thinning, and metabolic changes. The Time-Restricted Eating trial is investigating whether alternating periods of fasting and non-fasting can reduce these side effects and enhance the efficacy of radiation therapy.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer include enzalutamide, an oral nonsteroidal second-generation androgen receptor antagonist, which has shown efficacy in increasing median survival in metastatic castration-resistant prostate cancer (CRPC). Additionally, lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, has been approved for PSMA-positive metastatic CRPC, demonstrating significant improvements in progression-free survival and overall survival. While these treatments do not directly align with the concept of time-restricted eating, they represent advanced therapeutic options aimed at improving patient outcomes in prostate cancer.

What other types of research exist?

Promising novel alternatives to Time-Restricted Eating for prostate cancer patients include: 1) Short-term androgen-targeted therapy (ATT), which has shown feasibility and patient tolerability in reducing tumor volume and delaying disease progression. 2) Intermittent androgen deprivation (IAD), which aims to minimize adverse effects of continuous ADT while maintaining efficacy. 3) Anamorelin, a ghrelin mimetic, which has shown potential in managing cancer-related cachexia and improving quality of life. These alternatives offer different mechanisms to potentially enhance treatment outcomes and reduce side effects.

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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)

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

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 more

Awards & 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

Do I qualify?Apply below to find out

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.