NCT05722288

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

Recruiting now Phase 2 Last updated 29 August 2025

What this trial tests

Phase 2 trial testing Biospecimen Collection in Localized Prostate Carcinoma in 60 participants. Currently enrolling.

Timeline

20 January 2023

Primary endpoint
20 July 2026

20 July 2026

Quick facts

Lead sponsor	City of Hope Medical Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	20 January 2023
Primary completion	20 July 2026
Estimated completion	20 July 2026
Sites	1 location across United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Informational Intervention
• Quality-of-Life Assessment
• Questionnaire Administration
• Short-Term Fasting

Conditions studied

• Localized Prostate Carcinoma — all drugs for Localized Prostate Carcinoma →
• Locally Advanced Cervical Carcinoma — all drugs for Locally Advanced Cervical Carcinoma →
• Locally Advanced Rectal Carcinoma — all drugs for Locally Advanced Rectal Carcinoma →
• Malignant Solid Neoplasm — all drugs for Malignant Solid Neoplasm →

Sponsor

City of Hope Medical Center

Who can join

18 and older, any sex, with Localized Prostate Carcinoma or Locally Advanced Cervical Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of dietary intervention on human diseases: molecular mechanisms and therapeutic potential.
   Xiao YL, Gong Y, Qi YJ, Shao ZM, et al · · 2024 · cited 120× · PMID 38462638 · DOI 10.1038/s41392-024-01771-x
2. Dietary fat and lipid metabolism in the tumor microenvironment.
   Goswami S, Zhang Q, Celik CE, Reich EM, et al · · 2023 · cited 21× · PMID 37722512 · DOI 10.1016/j.bbcan.2023.188984
3. The Clinical Impact of Time-restricted Eating on Cancer: A Systematic Review.
   Stringer EJ, Cloke RWG, Van der Meer L, Murphy RA, et al · · 2025 · cited 5× · PMID 39212676 · DOI 10.1093/nutrit/nuae105
4. Intermittent fasting and its impact on toxicities, symptoms and quality of life in patients on active cancer treatment.
   Li Sucholeiki R, Propst CL, Hong DS, George GC. · · 2024 · cited 4× · PMID 38574507 · DOI 10.1016/j.ctrv.2024.102725
5. The advent of precision nutrigeroscience in cancer: from clinic towards molecular biology.
   Gao Z, Liu Y, Cui Y, Han Y, et al · · 2026 · cited 2× · PMID 40850675 · DOI 10.1016/j.jare.2025.08.034
6. Exploring prehabilitation interventions for patients with gynaecological cancer undergoing radiotherapy: A scoping review.
   McGladrigan E, Wrench E, Dean E, O'Neil A, et al · · 2025 · cited 2× · PMID 40080513 · DOI 10.1371/journal.pone.0319518