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

Study Overview
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Brief Summary
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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
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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: 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. 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.

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

Conditions
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Breast Carcinoma, Endometrial Carcinoma, Prostate Carcinosarcoma

Intervention / Treatment
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* Dietary Supplement: Dietary Intervention
* Other: Counseling
* Procedure: Therapeutic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary counseling, caloric restriction diet<br>Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery. | Dietary Supplement: Dietary Intervention<br>* Undergo caloric restriction diet<br>* Other names: Nutrition Intervention;Other: Counseling<br>* Undergo counselor-led dietary counseling<br>* Other names: Counseling Intervention;Procedure: Therapeutic<br>* Undergo standard of care surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 |  | Up to 12 weeks | 
| Change in body composition, assessed via BodyMetrix | Will be analyzed via a paired t-test. | Baseline up to 12 weeks | 
| Change in prostate tumor gene expression |  | Baseline up to 12 weeks | 
| Change in weight, defined as a percent change | Will be assessed by modeling BMI as a function of time via mixed-effects regression. | Baseline up to 12 weeks | 
| Change in temperature | 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) | Initial cancer biopsy specimen for genomic analysis will be comped to definitive surgical specimens. | Baseline to after definitive surgery | 
| Change in insulin | 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 |  | Baseline to 12 weeks | 
| Change in psycho-social outcomes, assessed by the FACT-B | 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) | Will be assessed as a function of time via mixed-effects regression. | Baseline up to 12 weeks | 
| Local recurrence, assessed through patient records | 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 | 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 | 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 | 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 | Will be assessed by modeling BMI as a function of time via mixed-effects regression. | Baseline up to 12 weeks | 
| Change in blood pressure | Will be assessed as a function of time via mixed-effects regression. | Baseline up to 12 weeks | 
| Change in heart rate | Will be assessed as a function of time via mixed-effects regression. | Baseline up to 12 weeks | 
| Change in respiratory rate | 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 | 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 | 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 | Will be assessed as a function of time via mixed-effects regression. | Baseline up to 12 weeks |