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Weight Gain Prevention for Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00533338
Recruitment Status : Active, not recruiting
First Posted : September 21, 2007
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The specific aims of this study are:

  1. To test the feasibility of a randomized controlled trial of a weight gain prevention program for breast cancer survivors that combines exercise and dietary changes during treatment. Feasibility will be evaluated by examining data on recruitment rate, attendance at intervention sessions, drop-out rates in both study conditions, assessment completion rates, and participant feedback.
  2. To test the effect of a weight gain prevention program, compared to usual care, on weight, body composition, and biomarkers related to breast cancer prognosis.
  3. To explore whether changes in physical activity, energy intake, and resting energy expenditure predict weight gain among breast cancer survivors.
  4. To test the effect of a weight gain prevention program on quality of life variables.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: Weight Gain Prevention Program Behavioral: Questionnaire

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Weight Gain Prevention for Breast Cancer Survivors
Actual Study Start Date : July 2007
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Weight Gain Prevention Program
Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling. Packet of questionnaires will be completed.
Behavioral: Weight Gain Prevention Program
Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling.
Behavioral: Questionnaire
Packet of questionnaires will be completed.
Other Name: Survey
Active Comparator: Standard Care Group
Packet of questionnaires will be completed.
Behavioral: Questionnaire
Packet of questionnaires will be completed.
Other Name: Survey


Outcome Measures

Primary Outcome Measures :
  1. Weight or Percentage (%) Body Fat [ Time Frame: Six assessments: baseline, 3 months after starting chemotherapy, at the end of chemotherapy, after recovery from surgery, at the end of the 9-week booster intervention, and 6 months after surgery. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Woman with newly diagnosed stage II or III breast cancer.
  2. Over 18 years of age.
  3. Beginning neo-adjuvant chemotherapy at M. D. Anderson (no more than 3 weeks from the administration of the first cycle).
  4. Speaks and reads English.
  5. Oriented to person, place, and time.
  6. Able to come to M. D. Anderson once a week for intervention.
  7. Has physician clearance to engage in moderate physical activity.
  8. Lives in Harris County, Texas or a county contiguous to Harris County, Texas.

Exclusion Criteria:

  1. Have any of the following conditions defined by the American College of Sports Medicine as absolute contraindications to exercise testing (a recent significant change in the resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 days) or acute cardiac event; unstable angina; uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise; severe symptomatic aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or pericarditis; suspected or known dissecting aneurysm; acute infection).
  2. Have any of the following conditions as defined by the American College of Sports Medicine as relative contraindications to exercise testing (left main coronary stenosis; moderate stenotic valvular heart disease; electrolyte abnormalities; severe arterial hypertension at rest; hypertrophic cardiomyopathy and other forms of outflow tract obstruction; neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise; high-degree atrioventricular block; ventricular aneurysm; uncontrolled metabolic disease; chronic infectious disease).
  3. Right or left bundle branch block.
  4. Baseline ST segment or T wave changes that would make monitoring of the ECG stress test indeterminate.
  5. Uncontrolled asthma.
  6. Have other medical contraindications as defined by the patient's physician.
  7. Have inflammatory breast cancer.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533338


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Lance Armstrong Foundation
Investigators
Principal Investigator: Karen Basen-Engquist, PhD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00533338     History of Changes
Other Study ID Numbers: 2005-0888
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Cancer Survivors
Weight Gain Prevention
Diet
Exercise
Questionnaire
Survey

Additional relevant MeSH terms:
Breast Neoplasms
Weight Gain
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms