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OpenTrials
Completed

NCT Number: NCT02983279

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

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Prostate Carcinosarcoma Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

PRIMARY OBJECTIVES:

  • 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:

  • Investigate measurable changes induced by caloric restriction on both patient (host) and tumor characteristics from caloric restriction.
  • Investigate the adherence of the patient to the diet.
  • Weight, height, and body composition will be assessed via BodyMetrix. BodyMetrix uses ultrasound technology to measure subcutaneous fat.
  • 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.
  • Patient's nutritional status (Mini Nutritional Assessment [MNA] form) will be assessed, and their caloric needs will be calculated.
  • Local recurrence, progression free survival, distant metastases and overall survival will be assessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

dietary intervention

Dietary Supplement

Undergo caloric restriction diet

Other names: Dietary Modification, Nutrition Intervention

Counseling

Other

Undergo counselor-led dietary counseling

Other names: Counseling Intervention

Therapeutic

Procedure

Undergo standard of care surgery

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Up to 12 weeks

  2. Change in body composition, assessed via BodyMetrix

    Time frame: Baseline up to 12 weeks

    Will be analyzed via a paired t-test.

  3. Change in prostate tumor gene expression

    Time frame: Baseline up to 12 weeks

  4. 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.

  5. Change in temperature

    Time frame: Baseline up to 12 weeks

    Will be assessed as a function of time via mixed-effects regression.

  6. 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.

  7. Change in insulin

    Time frame: Baseline up to 12 weeks

    Will be assessed as a function of time via mixed-effects regression.

  8. Change in biome analysis assessed by rectal swab

    Time frame: Baseline to 12 weeks

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Change in blood pressure

    Time frame: Baseline up to 12 weeks

    Will be assessed as a function of time via mixed-effects regression.

  17. Change in heart rate

    Time frame: Baseline up to 12 weeks

    Will be assessed as a function of time via mixed-effects regression.

  18. Change in respiratory rate

    Time frame: Baseline up to 12 weeks

    Will be assessed as a function of time via mixed-effects regression.

  19. 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.

  20. 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.

  21. 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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Dec 6, 2016
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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