Physical Activity or Usual Care in Preventing Weight Gain in Women With Stage I or Stage II Breast Cancer Undergoing Chemotherapy
This study has been completed.
Sponsor:
Fox Chase Cancer Center
Collaborator:
Information provided by:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00509626
First received: July 30, 2007
Last updated: February 11, 2010
Last verified: February 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Physical activity may prevent or reduce weight gain in women receiving chemotherapy for early stage breast cancer.
PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it works compared with usual care to prevent or reduce weight gain in women with stage I or stage II breast cancer undergoing chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Depression Fatigue Psychosocial Effects of Cancer and Its Treatment Weight Changes |
Behavioral: exercise intervention Other: questionnaire administration Procedure: CAM exercise therapy Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | A Physical Activity Intervention to Prevent Weight Gain in Breast Cancer Patients |
Resource links provided by NLM:
Further study details as provided by Fox Chase Cancer Center:
Primary Outcome Measures:
- Accrual (phase I) [ Designated as safety issue: No ]
- Retention (phase I) [ Designated as safety issue: No ]
- Weight change after 6 months (phase II) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adiposity as measured by waist circumference at 3 and 6 months [ Designated as safety issue: No ]
- Health-related quality of life as measured by the Short-Form Health Survey-12 Physical and Mental Component Summary scales [ Designated as safety issue: No ]
- Depressive symptomology as measured by the Center for Epidemiologic Studies Depression Scale [ Designated as safety issue: No ]
| Estimated Enrollment: | 380 |
| Study Start Date: | June 2007 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria:
Diagnosis of primary breast cancer
- Newly diagnosed stage I or II disease
Receiving care at a participating Fox Chase Cancer Center CCOP Research Base (FCRB) member site
- Geisinger Clinic and Medical Center (phase I)
- Main Line Health (phase I)
- Any of the other participating FCRB member sites (phase II)
- Study intervention is scheduled to begin anytime after surgery up to 3 months after completion of adjuvant chemotherapy
- Treatment plan includes adjuvant chemotherapy
- Hormone receptor status not specified
Exclusion criteria:
- Treatment plan includes trastuzumab (Herceptin®) or bevacizumab
- Recurrent breast cancer
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Female
- Premenopausal or postmenopausal
- Has obtained medical clearance by oncologist and breast surgeon to participate in this study
- Body mass index ≥ 20 kg/m^2 and < 39 kg/m^2
Exclusion criteria:
- Hemoglobin < 12 g/dL
- ANC < 1,500/mm^3
- Any medical condition that restricts participation in a physical activity program (e.g., exercise-induced angina, uncontrolled hypertension, dementia, or a major psychological problem)
- Answers "yes" to any questions on the Physical Activity Readiness Questionnaire (PAR-Q) and PAR-Q not reviewed by a physician who subsequently approves participation in the physical activity intervention
- Known to be pregnant or breastfeeding
- Unwilling to commit or unable to participate in a 6-month physical activity intervention (unable to exercise, usually travels away from home overnight more than once per week, and/or has plans to be away from home for more than two weeks in the next 6 months)
- Previously diagnosed with another primary cancer other than basal cell or squamous cell carcinoma of the skin
- Exercising regularly prior to intervention (i.e., reports current participation in vigorous or moderate activity at least 3 days per week for at least 30 minutes each day on the International Physical Activity Questionnaire)
- Unable to speak and read English
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No neoadjuvant chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509626
Locations
| United States, Pennsylvania | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
| Study Chair: | Penny Anderson, MD | Fox Chase Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00509626 History of Changes |
| Other Study ID Numbers: | CDR0000555830, P30CA006927, FCCC-FCRB-05-009 |
| Study First Received: | July 30, 2007 |
| Last Updated: | February 11, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fox Chase Cancer Center:
|
fatigue psychosocial effects of cancer and its treatment weight changes |
depression stage I breast cancer stage II breast cancer |
Additional relevant MeSH terms:
|
Body Weight Changes Breast Neoplasms Depression Depressive Disorder Fatigue Weight Gain Body Weight Signs and Symptoms |
Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013