Clinical trial NCT02983279: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Endometrial Carcinoma
Prostate Carcinosarcoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in miR-21 expression assessed in serum
timeFrame: Baseline up to 12 weeks
Secondary outcomes:
measure: Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target
timeFrame: Up to 12 weeks
measure: Change in body composition, assessed via BodyMetrix
timeFrame: Baseline up to 12 weeks
measure: Change in prostate tumor gene expression
timeFrame: Baseline up to 12 weeks
measure: Change in weight, defined as a percent change
timeFrame: Baseline up to 12 weeks
measure: Change in temperature
timeFrame: Baseline up to 12 weeks
measure: Change in genomic expression of microRNA 21 (miR-21)
timeFrame: Baseline to after definitive surgery
measure: Change in insulin
timeFrame: Baseline up to 12 weeks
measure: Change in biome analysis assessed by rectal swab
timeFrame: Baseline to 12 weeks
measure: Change in psycho-social outcomes, assessed by the FACT-B
timeFrame: Baseline up to 12 weeks
measure: Changes in nutritional status assessed by a Mini Nutritional Assessment (MNA)
timeFrame: Baseline up to 12 weeks
measure: Local recurrence, assessed through patient records
timeFrame: From the date of study enrollment to time of event, assessed up to 12 weeks
measure: Distant metastases, assessed through patient records
timeFrame: From the date of study enrollment to time of event, assessed up to 12 weeks
measure: Progression free survival, assessed through patient records
timeFrame: From the date of study enrollment to time of event, assessed up to 12 weeks
measure: Overall survival, assessed through patient records
timeFrame: From the date of study enrollment to time of event, assessed up to 12 weeks
measure: Change in weight, defined by body mass index as weight in kg divided by height in meters squared
timeFrame: Baseline up to 12 weeks
measure: Change in blood pressure
timeFrame: Baseline up to 12 weeks
measure: Change in heart rate
timeFrame: Baseline up to 12 weeks
measure: Change in respiratory rate
timeFrame: Baseline up to 12 weeks
measure: Change in psycho-social outcomes, assessed by the FACT-P
timeFrame: Baseline up to 12 weeks
measure: Change in psycho-social outcomes, assessed by the FACT-En
timeFrame: Baseline up to 12 weeks
measure: Change in psycho-social outcomes, assessed by the POMIS cancer fatigue short form
timeFrame: Baseline up to 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Nicole Simone, MD
role: PRINCIPAL_INVESTIGATOR
References: