NCT02983279

Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer

Caloric Restriction for Oncology Research: Pre-operative Caloric Restriction Prior to Definitive Oncologic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine that sort term calorie restriction will affect tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.

Detailed description

PRIMARY OBJECTIVES: 1\) Investigate if caloric restriction will change serum micro ribonucleic acid (RNA) 21 (miR-21) expression in patients with prostate, endometrial or breast cancer. SECONDARY OBJECTIVES: 1. Investigate measurable changes induced by caloric restriction on both patient (host) and tumor characteristics from caloric restriction. 2. Investigate the adherence of the patient to the diet. 4\) Weight, height, and body composition will be assessed via BodyMetrix. BodyMetrix uses ultrasound technology to measure subcutaneous fat. 5\) Patients will have psycho-social evaluation using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) test (prostate cancer), FACT-Breast (B) test (breast cancer), or the FACT-Endometrial Cancer (En) test (endometrial cancer) and the Patient Reported Outcomes Measurement Information System (PROMIS) cancer fatigue short form at baseline, midway through diet, and at the conclusion of the diet. 6\) Patient's nutritional status (Mini Nutritional Assessment \[MNA\] form) will be assessed, and their caloric needs will be calculated. 7\) Local recurrence, progression free survival, distant metastases and overall survival will be assessed.

Conditions

• Breast Carcinoma
• Endometrial Carcinoma
• Prostate Carcinosarcoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Intervention	Undergo caloric restriction diet
OTHER	Counseling	Undergo counselor-led dietary counseling
PROCEDURE	Therapeutic	Undergo standard of care surgery

Timeline

• Start date: 2016-09-20
• Primary completion: 2021-10-27
• Completion: 2022-12-29
• First posted: 2016-12-06
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States