Breast Cancer Clinical Trial
Official title:
Randomized Controlled Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors. The CARE Trial.
Verified date | June 2014 |
Source | AHS Cancer Control Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Endurance exercise such as walking has been shown to help breast cancer survivors maintain their energy and quality of life while they are receiving chemotherapy, but there have not been any studies on weight training. In this study, the researchers want to determine if a combined program of endurance and weight training exercises is better than a standard amount of endurance exercise or even a higher amount of endurance exercise in breast cancer survivors receiving chemotherapy. The study will be an experimental design in which the researchers have breast cancer survivors participate in one of the three different exercise programs. The researchers' main interest is in patient rated physical functioning and quality of life, which they will measure before and after the exercise programs by asking participants how they feel on various rating scales. The researchers will also measure their aerobic fitness on a treadmill and how strong they are by having them lift weights.
Status | Completed |
Enrollment | 301 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
- Are diagnosed with stage I-IIIA breast cancer, histologically confirmed - Are scheduled to receive adjuvant chemotherapy (receiving neoadjuvant chemotherapy for locally advanced cancer is an exclusion criteria) - Have not received previous chemotherapy (previous cancer is NOT an exclusion criteria) - Have not received transabdominal rectus abdominis muscle (TRAM) reconstructive surgery - Are 18 years or older - Received approval from their treating oncologist - No uncontrolled hypertension, cardiac illness or psychiatric condition or any other medical condition that would be a contraindication to exercise - Able to understand and provide written informed consent in English or French (Ottawa) - Complete maximal aerobic and strength tests. No contraindication to exercise as determined by fitness tests - Are not pregnant - Willing to accept randomization and complete their assigned exercise program - If participant is currently exercising (e.g., swimming at the Y 3 times per week) must be willing to give this up in place of their randomly assigned program - Willing to travel to fitness center 3 times/week to complete exercise program - Willing to complete all assessments (except blood) at all timepoints including 6, 12, and 24 month follow-ups - Must not have a planned/known absence of greater than 2 weeks during the intended intervention period and must be able/willing to perform exercise sessions on their own during any planned absences of less than 2 weeks |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
AHS Cancer Control Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient rated physical functioning | at 8 weeks and 24 weeks | Yes | |
Secondary | Physical fitness, body composition, treatment completion rates, exercise adherence rates, adverse events | at 8 weeks and 24 weeks | Yes |
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