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NCT01819233 · ClinicalTrials.gov registry record · NA
Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy
A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT01819233: Completed NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT01819233 is a NA study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01819233, a NA study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving dietary intervention and radiation therapy together may kill more tumor cells.
Primary Outcome
Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.
Interventions
- RADIATION Radiation therapy
- PROCEDURE Quality-of-life assessment
- OTHER Counseling intervention
- BEHAVIORAL Behavioral dietary intervention
- PROCEDURE Therapeutic conventional surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-03-08 |
| Est. Completion | 2019-09 |
| Phase | NA |
What the finished NCT01819233 record still lists
NCT01819233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which Radiation therapy is the first listed.
NCT01819233 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01819233 about?
NCT01819233 is a clinical study titled "Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy". This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving dietary i...
What is the current status of trial NCT01819233?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2013-03-08. Estimated completion is 2019-09.
What interventions are being tested in trial NCT01819233?
The interventions under investigation include: Radiation therapy (RADIATION), Quality-of-life assessment (PROCEDURE), Counseling intervention (OTHER), Behavioral dietary intervention (BEHAVIORAL), Therapeutic conventional surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01819233?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01819233's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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