Weight Gain Prevention for Breast Cancer Survivors
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Jul 2007
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2007
CompletedFirst Submitted
Initial submission to the registry
September 19, 2007
CompletedFirst Posted
Study publicly available on registry
September 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedJanuary 13, 2020
January 1, 2020
13 years
September 19, 2007
January 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight or Percentage (%) Body Fat
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.
Study Arms (2)
Weight Gain Prevention Program
EXPERIMENTALIntervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling. Packet of questionnaires will be completed.
Standard Care Group
ACTIVE COMPARATORPacket of questionnaires will be completed.
Interventions
Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling.
Packet of questionnaires will be completed.
Eligibility Criteria
You may qualify if:
- Woman with newly diagnosed stage II or III breast cancer.
- Over 18 years of age.
- Beginning neo-adjuvant chemotherapy at M. D. Anderson (no more than 3 weeks from the administration of the first cycle).
- Speaks and reads English.
- Oriented to person, place, and time.
- Able to come to M. D. Anderson once a week for intervention.
- Has physician clearance to engage in moderate physical activity.
- Lives in Harris County, Texas or a county contiguous to Harris County, Texas.
You may not qualify if:
- 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).
- 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).
- Right or left bundle branch block.
- Baseline ST segment or T wave changes that would make monitoring of the ECG stress test indeterminate.
- Uncontrolled asthma.
- Have other medical contraindications as defined by the patient's physician.
- Have inflammatory breast cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Lance Armstrong Foundationcollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Basen-Engquist KM, Raber M, Carmack CL, Arun B, Brewster AM, Fingeret M, Schembre SM, Harrison C, Perkins HY, Li Y, Song J, Chen M, Murray JL. Feasibility and efficacy of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy: a randomized controlled pilot study. Support Care Cancer. 2020 Dec;28(12):5821-5832. doi: 10.1007/s00520-020-05411-2. Epub 2020 Apr 5.
PMID: 32249355DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Basen-Engquist, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2007
First Posted
September 21, 2007
Study Start
July 20, 2007
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
January 13, 2020
Record last verified: 2020-01