Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
Primary Purpose
Breast Carcinoma, Endometrial Carcinoma, Prostate Carcinosarcoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Counseling
Therapeutic
Sponsored by
About this trial
This is an interventional treatment trial for Breast Carcinoma
Eligibility Criteria
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
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dietary counseling, caloric restriction diet
Arm Description
Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.
Outcomes
Primary Outcome Measures
Change in miR-21 expression assessed in serum
Will be evaluated by a two-sided paired t-test at significance level 0.05.
Secondary Outcome Measures
Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target
Change in body composition, assessed via BodyMetrix
Will be analyzed via a paired t-test.
Change in prostate tumor gene expression
Change in weight, defined as a percent change
Will be assessed by modeling BMI as a function of time via mixed-effects regression.
Change in temperature
Will be assessed as a function of time via mixed-effects regression.
Change in genomic expression of microRNA 21 (miR-21)
Initial cancer biopsy specimen for genomic analysis will be comped to definitive surgical specimens.
Change in insulin
Will be assessed as a function of time via mixed-effects regression.
Change in biome analysis assessed by rectal swab
Change in psycho-social outcomes, assessed by the FACT-B
Will be assessed as a function of time via mixed-effects regression.
Changes in nutritional status assessed by a Mini Nutritional Assessment (MNA)
Will be assessed as a function of time via mixed-effects regression.
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.
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.
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.
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.
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.
Change in blood pressure
Will be assessed as a function of time via mixed-effects regression.
Change in heart rate
Will be assessed as a function of time via mixed-effects regression.
Change in respiratory rate
Will be assessed as a function of time via mixed-effects regression.
Change in psycho-social outcomes, assessed by the FACT-P
Will be assessed as a function of time via mixed-effects regression.
Change in psycho-social outcomes, assessed by the FACT-En
Will be assessed as a function of time via mixed-effects regression.
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.
Full Information
NCT ID
NCT02983279
First Posted
November 14, 2016
Last Updated
January 4, 2023
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT02983279
Brief Title
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
Official Title
Caloric Restriction for Oncology Research: Pre-operative Caloric Restriction Prior to Definitive Oncologic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
October 27, 2021 (Actual)
Study Completion Date
December 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Endometrial Carcinoma, Prostate Carcinosarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary counseling, caloric restriction diet
Arm Type
Experimental
Arm Description
Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, Nutrition Intervention
Intervention Description
Undergo caloric restriction diet
Intervention Type
Other
Intervention Name(s)
Counseling
Other Intervention Name(s)
Counseling Intervention
Intervention Description
Undergo counselor-led dietary counseling
Intervention Type
Procedure
Intervention Name(s)
Therapeutic
Intervention Description
Undergo standard of care surgery
Primary Outcome Measure Information:
Title
Change in miR-21 expression assessed in serum
Description
Will be evaluated by a two-sided paired t-test at significance level 0.05.
Time Frame
Baseline up to 12 weeks
Secondary Outcome Measure Information:
Title
Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target
Time Frame
Up to 12 weeks
Title
Change in body composition, assessed via BodyMetrix
Description
Will be analyzed via a paired t-test.
Time Frame
Baseline up to 12 weeks
Title
Change in prostate tumor gene expression
Time Frame
Baseline up to 12 weeks
Title
Change in weight, defined as a percent change
Description
Will be assessed by modeling BMI as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Change in temperature
Description
Will be assessed as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Change in genomic expression of microRNA 21 (miR-21)
Description
Initial cancer biopsy specimen for genomic analysis will be comped to definitive surgical specimens.
Time Frame
Baseline to after definitive surgery
Title
Change in insulin
Description
Will be assessed as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Change in biome analysis assessed by rectal swab
Time Frame
Baseline to 12 weeks
Title
Change in psycho-social outcomes, assessed by the FACT-B
Description
Will be assessed as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Changes in nutritional status assessed by a Mini Nutritional Assessment (MNA)
Description
Will be assessed as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Local recurrence, assessed through patient records
Description
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.
Time Frame
From the date of study enrollment to time of event, assessed up to 12 weeks
Title
Distant metastases, assessed through patient records
Description
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.
Time Frame
From the date of study enrollment to time of event, assessed up to 12 weeks
Title
Progression free survival, assessed through patient records
Description
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.
Time Frame
From the date of study enrollment to time of event, assessed up to 12 weeks
Title
Overall survival, assessed through patient records
Description
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.
Time Frame
From the date of study enrollment to time of event, assessed up to 12 weeks
Title
Change in weight, defined by body mass index as weight in kg divided by height in meters squared
Description
Will be assessed by modeling BMI as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Change in blood pressure
Description
Will be assessed as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Change in heart rate
Description
Will be assessed as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Change in respiratory rate
Description
Will be assessed as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Change in psycho-social outcomes, assessed by the FACT-P
Description
Will be assessed as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Change in psycho-social outcomes, assessed by the FACT-En
Description
Will be assessed as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
Title
Change in psycho-social outcomes, assessed by the POMIS cancer fatigue short form
Description
Will be assessed as a function of time via mixed-effects regression.
Time Frame
Baseline up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Simone, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
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