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

NCT02983279 | Completed DMC

• 2 other identifiers: 16D.501JT 8646
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Carcinoma; Endometrial Carcinoma; Prostate Carcinosarcoma

Outcome Measures

Primary Outcomes (1)

• Change in miR-21 expression assessed in serum

  Will be evaluated by a two-sided paired t-test at significance level 0.05.

  Baseline up to 12 weeks

Secondary Outcomes (21)

• Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target

  Up to 12 weeks

• Change in body composition, assessed via BodyMetrix

  Baseline up to 12 weeks

• Change in prostate tumor gene expression

  Baseline up to 12 weeks

• Change in weight, defined as a percent change

  Baseline up to 12 weeks

• Change in temperature

  Baseline up to 12 weeks

Study Arms (1)

Dietary counseling, caloric restriction diet

EXPERIMENTAL

Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.

Dietary Supplement: Dietary Intervention; Other: Counseling; Procedure: Therapeutic

Interventions

Dietary Intervention DIETARY_SUPPLEMENT

Undergo caloric restriction diet

Also known as: Dietary Modification, Nutrition Intervention

Dietary counseling, caloric restriction diet

Counseling OTHER

Undergo counselor-led dietary counseling

Also known as: Counseling Intervention

Dietary counseling, caloric restriction diet

Therapeutic PROCEDURE

Undergo standard of care surgery

Dietary counseling, caloric restriction diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological documentation of cancer of the endometrium, prostate or breast.
• Candidate for definitive cancer surgery as determined by treating physician
• The ability for the definitive cancer surgery to be scheduled within 4-12 weeks post initiation of dietary intervention as determined by the enrolling physician (not from diagnosis - but from start of diet).
• No other malignancy within the past 6 months unless it was a non-melanomatous skin lesion
• BMI ≥21
• ECOG Performance Status of 2 or less
• Patient must not be on anti-retrovirals since they may alter patient metabolism

You may not qualify if:

• Patient is not a candidate for definitive cancer surgery
• Definitive cancer surgery can not be performed within 4-12 weeks post study enrollment as determined by the enrolling physician.
• Body Mass Index \< 21
• Another malignancy within the past 6 months that was not a non-melanomatous skin lesion
• ECOG Performance Status \>2
• Patient on anti-retrovirals since they may alter patient metabolism

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Breast Neoplasms; Endometrial Neoplasms

Interventions

Diet Therapy; Counseling; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nicole Simone, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: December 6, 2016
• Study Start: September 20, 2016
• Primary Completion: October 27, 2021
• Study Completion: December 29, 2022
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)