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Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial


N/A
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Overweight, Obesity

Thank you

Trial Information

Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial


Inclusion Criteria:



- Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding
distant metastasis) diagnosed between 6 months and 5 years earlier; after initial
therapies are completed, diagnosed between six months and five years earlier

- BMI between 25 to 45 kg/m2

- Able to comply with all required study procedures and schedule

Exclusion Criteria:

- Serious medical condition or psychiatric illness

- Inability to be moderately physically active

- Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS)

- Currently enrolled in a weight loss program

- Current use of weight loss medication or supplements

- Previous surgical procedures for weight reduction

- Planning weight loss surgery in the next 2 years.

- 6+ months use of meds likely to cause weight gain or prevent weight loss

- Planned surgical procedure that can impact the conduct of the study

- Currently pregnant/breastfeeding

- Planning to become pregnant within the next 2 years

- Have plans to relocate from area within 2 years

- Family relative or close friend is a trial staff member or a study participant

- Any condition which in the opinion of the investigator makes the subject unsuitable
for inclusion in this study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Weight loss

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Cheryl L. Rock, PhD, RD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego

Authority:

United States: Institutional Review Board

Study ID:

CA148791-01

NCT ID:

NCT01112839

Start Date:

May 2010

Completion Date:

April 2014

Related Keywords:

  • Breast Cancer
  • Overweight
  • Obesity
  • Overweight
  • Obese
  • Breast cancer survivors
  • Weight loss
  • Exercise
  • Physical activity
  • Breast Neoplasms
  • Obesity
  • Recurrence
  • Weight Loss
  • Overweight

Name

Location

Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of Colorado DenverDenver, Colorado  80262
Washington University in St. Louis:St. Louis, Missouri  63110