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Obesity-related Mechanisms and Mortality in Breast Cancer Survivors


N/A
N/A
N/A
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information

Obesity-related Mechanisms and Mortality in Breast Cancer Survivors


Inclusion Criteria:



- BMI at least 25.0 kg/m2

- Diagnosed with Stage I, II, or III breast cancer within past 5 years

- Treatment with total mastectomy or breast-sparing surgical removal of cancer with
clear macroscopic margins, and axillary dissection, followed by adjuvant breast
radiation

- Not scheduled for or currently undergoing chemotherapy

- Accessible geographically and by telephone

- Able to communicate dietary and physical activity data via telephone

- If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on
treatment for 6-month study period

- Post-menopausal at diagnosis

Exclusion Criteria:

- Preliminary bloodwork outside of specified ranges

- Evidence of renal insufficiency, liver disease, or congestive heart failure

- Currently taking corticosteroid pills or steroid hormone therapy (including vaginal
estrogen creams)

- Recent initiation (< 3 months ago) of thiazides or β-blockers

- Taking insulin or other antidiabetic drug

- Other primary or recurrent invasive cancer in past 10 years

- Unable to commit to study requirements

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Biological markers associated with breast cancer survival

Outcome Time Frame:

Baseline, 6 months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

U54 CA155435-01 Project 3

NCT ID:

NCT01302379

Start Date:

August 2011

Completion Date:

July 2016

Related Keywords:

  • Breast Neoplasms
  • Obesity
  • Survival
  • Weight loss
  • Metformin
  • Biological markers
  • Breast Neoplasms
  • Neoplasms
  • Obesity

Name

Location

Moores UCSD Cancer Center La Jolla, California  92093-0658