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NCT05722288 · ClinicalTrials.gov registry record · Phase 2
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
A Phase 2 study of Malignant Solid Neoplasm and Recurrent Prostate Carcinoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05722288: Recruiting Phase 2 study of Malignant Solid Neoplasm and Recurrent Prostate Carcinoma, sponsored by City of Hope Medical Center.
NCT05722288 is a Phase 2 study of Malignant Solid Neoplasm and Recurrent Prostate Carcinoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 60 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05722288, a Phase 2 study of Malignant Solid Neoplasm and Recurrent Prostate Carcinoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Will be measured by the gH2ax assay. The study population will be described by, and randomized groups compared with respect to baseline characteristics including demographics (age, race/ethnicity, education, gender for rectal cancer), clinical characteristics (prostate: pre-treatment prostate-specific antigen \[PSA\], National Comprehensive Cancer Network \[NCCN\] staging and rectal: American Joint Committee on Cancer version 8 \[AJCC8\] staging), and metabolic features (diabetes, HbA1c, waist c
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- OTHER Informational Intervention
- BEHAVIORAL Short-Term Fasting
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-01-20 |
| Est. Completion | 2026-07-20 |
| Phase | Phase 2 |
What NCT05722288 shows while recruiting
NCT05722288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (95% lower).
The record links to 10 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05722288 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05722288 about?
NCT05722288 is a clinical study titled "Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers". 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 intermi...
What is the current status of trial NCT05722288?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-01-20. Estimated completion is 2026-07-20.
What conditions does trial NCT05722288 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Recurrent Prostate Carcinoma, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Localized Prostate Carcinoma.
What interventions are being tested in trial NCT05722288?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Informational Intervention (OTHER), Short-Term Fasting (BEHAVIORAL).
Who is sponsoring clinical trial NCT05722288?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05722288 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05722288's enrollment target sits among peer trials
60 115th of 176 higher than 56 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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