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

April 28, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histological documentation of cancer of the endometrium, prostate or breast.
  2. Candidate for definitive cancer surgery as determined by treating physician
  3. 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).
  4. No other malignancy within the past 6 months unless it was a non-melanomatous skin lesion
  5. BMI ≥21
  6. ECOG Performance Status of 2 or less
  7. Patient must not be on anti-retrovirals since they may alter patient metabolism

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary counseling, caloric restriction diet
Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.
Dietary supplement: Dietary Intervention
Undergo caloric restriction diet
Other Names:
  • Dietary Modification
  • Nutrition Intervention
Other: Counseling
Undergo counselor-led dietary counseling
Other Names:
  • Counseling Intervention
Procedure: Therapeutic
Undergo standard of care surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in miR-21 expression assessed in serum
Time Frame: Baseline up to 12 weeks
Will be evaluated by a two-sided paired t-test at significance level 0.05.
Baseline up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target
Time Frame: Up to 12 weeks
Up to 12 weeks
Change in body composition, assessed via BodyMetrix
Time Frame: Baseline up to 12 weeks
Will be analyzed via a paired t-test.
Baseline up to 12 weeks
Change in prostate tumor gene expression
Time Frame: Baseline up to 12 weeks
Baseline up to 12 weeks
Change in weight, defined as a percent change
Time Frame: Baseline up to 12 weeks
Will be assessed by modeling BMI as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Change in temperature
Time Frame: Baseline up to 12 weeks
Will be assessed as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Change in genomic expression of microRNA 21 (miR-21)
Time Frame: Baseline to after definitive surgery
Initial cancer biopsy specimen for genomic analysis will be comped to definitive surgical specimens.
Baseline to after definitive surgery
Change in insulin
Time Frame: Baseline up to 12 weeks
Will be assessed as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Change in biome analysis assessed by rectal swab
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks
Change in psycho-social outcomes, assessed by the FACT-B
Time Frame: Baseline up to 12 weeks
Will be assessed as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Changes in nutritional status assessed by a Mini Nutritional Assessment (MNA)
Time Frame: Baseline up to 12 weeks
Will be assessed as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Local recurrence, assessed through patient records
Time Frame: From the date of study enrollment to time of event, assessed up to 12 weeks
Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
From the date of study enrollment to time of event, assessed up to 12 weeks
Distant metastases, assessed through patient records
Time Frame: From the date of study enrollment to time of event, assessed up to 12 weeks
Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
From the date of study enrollment to time of event, assessed up to 12 weeks
Progression free survival, assessed through patient records
Time Frame: From the date of study enrollment to time of event, assessed up to 12 weeks
Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
From the date of study enrollment to time of event, assessed up to 12 weeks
Overall survival, assessed through patient records
Time Frame: From the date of study enrollment to time of event, assessed up to 12 weeks
Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
From the date of study enrollment to time of event, assessed up to 12 weeks
Change in weight, defined by body mass index as weight in kg divided by height in meters squared
Time Frame: Baseline up to 12 weeks
Will be assessed by modeling BMI as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Change in blood pressure
Time Frame: Baseline up to 12 weeks
Will be assessed as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Change in heart rate
Time Frame: Baseline up to 12 weeks
Will be assessed as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Change in respiratory rate
Time Frame: Baseline up to 12 weeks
Will be assessed as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Change in psycho-social outcomes, assessed by the FACT-P
Time Frame: Baseline up to 12 weeks
Will be assessed as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Change in psycho-social outcomes, assessed by the FACT-En
Time Frame: Baseline up to 12 weeks
Will be assessed as a function of time via mixed-effects regression.
Baseline up to 12 weeks
Change in psycho-social outcomes, assessed by the POMIS cancer fatigue short form
Time Frame: Baseline up to 12 weeks
Will be assessed as a function of time via mixed-effects regression.
Baseline up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Nicole Simone, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2016

Primary Completion (Actual)

October 27, 2021

Study Completion (Actual)

December 29, 2022

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimated)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16D.501
  • JT 8646 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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