Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JT 8646 | Other Identifier | JeffTrial Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary counseling, caloric restriction diet | Experimental | Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Dietary Supplement | Undergo caloric restriction diet |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicole Simone, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
Not provided
| Label | URL |
|---|---|
| Thomas Jefferson University Hospital | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Counseling | Other | Undergo counselor-led dietary counseling |
|
|
| Therapeutic | Procedure | Undergo standard of care surgery |
|
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D003376 | Counseling |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided