- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02983279
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
Caloric Restriction for Oncology Research: Pre-operative Caloric Restriction Prior to Definitive Oncologic Surgery
Study Overview
Status
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:
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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.
|
Undergo caloric restriction diet
Other Names:
Undergo counselor-led dietary counseling
Other Names:
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
Investigators
- Principal Investigator: Nicole Simone, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Breast Diseases
- Neoplasms, Complex and Mixed
- Sarcoma
- Breast Neoplasms
- Carcinoma
- Endometrial Neoplasms
- Carcinosarcoma
- Mixed Tumor, Mullerian
Other Study ID Numbers
- 16D.501
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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