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Therapeutic for Breast Cancer

N/A
Waitlist Available
Led By Nicole Simone, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
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 baseline up to 12 weeks
Awards & highlights

Study Summary

This trial is testing whether short-term calorie restriction will positively impact biomarkers in people with biopsy-proven breast, endometrial, or prostate cancer.

Eligible Conditions
  • Breast Cancer
  • Endometrial Cancer
  • Prostate Carcinosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in miR-21 expression assessed in serum
Secondary outcome measures
Activation Analysis
Change in blood pressure
Change in body composition, assessed via BodyMetrix
+18 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dietary counseling, caloric restriction dietExperimental Treatment3 Interventions
Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Intervention
2014
Completed Phase 2
~2550
Therapeutic
2016
N/A
~50

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,862 Total Patients Enrolled
6 Trials studying Breast Cancer
369 Patients Enrolled for Breast Cancer
Nicole Simone, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
4 Previous Clinical Trials
301 Total Patients Enrolled
1 Trials studying Breast Cancer
200 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
2016. "Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02983279.
~6 spots leftby Apr 2025
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