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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983279
• Other study ID #: 16D.501
• Status: Completed
• Phase: N/A
• Start date: September 20, 2016
• Est. completion date: December 29, 2022

Study information

• Verified date: January 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 29, 2022
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinosarcoma
• Endometrial Carcinoma
• Endometrial Neoplasms
• Mixed Tumor, Mullerian
• Prostate Carcinosarcoma

Intervention

Dietary Supplement:
• Dietary Intervention
Undergo caloric restriction diet

Other:
• Counseling
Undergo counselor-led dietary counseling

Procedure:
• Therapeutic
Undergo standard of care surgery

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target		Up to 12 weeks
Secondary	Change in body composition, assessed via BodyMetrix	Will be analyzed via a paired t-test.	Baseline up to 12 weeks
Secondary	Change in prostate tumor gene expression		Baseline up to 12 weeks
Secondary	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
Secondary	Change in temperature	Will be assessed as a function of time via mixed-effects regression.	Baseline up to 12 weeks
Secondary	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
Secondary	Change in insulin	Will be assessed as a function of time via mixed-effects regression.	Baseline up to 12 weeks
Secondary	Change in biome analysis assessed by rectal swab		Baseline to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in blood pressure	Will be assessed as a function of time via mixed-effects regression.	Baseline up to 12 weeks
Secondary	Change in heart rate	Will be assessed as a function of time via mixed-effects regression.	Baseline up to 12 weeks
Secondary	Change in respiratory rate	Will be assessed as a function of time via mixed-effects regression.	Baseline up to 12 weeks
Secondary	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
Secondary	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
Secondary	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

External Links

•   Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
•   Thomas Jefferson University Hospital