None listed
Conditions
Brief summary
The study will assess the feasibility of a specified exercise program in patients with advanced breast cancer and its impact on improving fatigue. Who is it for? You may be eligible to join this study if you are a female with metastatic breast cancer aged between 18-80 years, and are being managed at Breast Cancer Research Centre- WA. Eligible women will also have experienced subjective fatigue in the past several weeks as a persistent symptom. Study details This study will be conducted in two parts. In Part 1, eligible patients will be offered a 6 week exercise program, where the primary endpoint will be to assess feasibility and overall safety. If the program is deemed as being feasible and safe, Part 2 of the study will commence. In Part 2, participants will be randomly (by chance) allocated to one of two groups. Participants in one group will be offered the 6 week exercise program, whilst participants in the other group will not participate in the exercise program. On completion of the program, participants will be asked to complete some questionnaires to assess their levels of fatigue, depression and pain. They will also be asked to conduct a brief walking test to assess any changes in aerobic fitness.
Interventions
The intervention is a 6 Week Exercise Program which will be offered as 1 hour sessions twice a week for 6 weeks.
The Exercise sessions include:
1. 10 minutes of warm-up using the large muscle groups in arms & legs on a treadmill, bike or rowing machine (mild paced and customized to individual capability)
2. 30 minutes of resistance exercise against own body weight or the weight of an object using arms and legs (customized to individual capability)
3. The last 10 minutes is for stretching exercis
The intervention is a 6 Week Exercise Program which will be offered as 1 hour sessions twice a week for 6 weeks. The Exercise sessions include: 1. 10 minutes of warm-up using the large muscle groups in arms & legs on a treadmill, bike or rowing machine (mild paced and customized to individual capability) 2. 30 minutes of resistance exercise against own body weight or the weight of an object using arms and legs (customized to individual capability) 3. The last 10 minutes is for stretching exercises. The exercise sessions will be conducted at the Specialist Sports and Spinal Physiotherapy, Nedlands, WA 6009. It will conducted under supervision of an experienced physiotherapist and will be either individual sessions or a group session of not more than 4 participants. The study will be conducted in two parts. In Part 1, the exercise program will be offered to approx. 8 eligible patients over a 6-week duration, where the primary endpoint will be to assess feasibility and overall safety. If 80% of the exercise program is completed in greater than or equal to 75% of recruited patients (i.e. at least 6 of 8 patients) without occurrence of a serious adverse event occurring during the exercise program (as assessed by the study physiotherapist and treating clinician), the exercise program will be deemed as being feasible and safe to move into Part 2 of the study. In the event that a serious adverse event occurs during the exercise program, a modified exercise program will be evaluated in a further group of 8 patients. If 80% of the exercise program is completed in greater than or equal to 75% of recruited patients (i.e. at least 6 of 8 patients) without occurrence of a serious adverse event occurring during the modified exercise program (as assessed by the study physiotherapist and treating clinician), the exercise program will be deemed as being feasible. In Part 2, the 6 Week program will be offered to a larger group of patients to evaluate for an improvement in levels of fatigue experienced by patients with Metastatic Breast Cancer.
Sponsors
Breast Cancer Research Centre - WA
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Metastatic breast cancer patients >=18 years of age and managed at BCRC-WA, who have experienced subjective fatigue in the past several weeks as a persistent symptom 2. Assessed by the treating oncologist within the past 3 months as having stable metastatic disease on current systemic treatment. 3. Performance status (ECOG) of 0-2 4. Life expectancy of greater than 6-months 5. English speaking 6. Able to walk continuously (non-stop) at a comfortable pace for a minimum of 6 minutes or 120 meters. 7. Able to maintain compliance with study treatment and assessments 8. Signed informed consent
Exclusion criteria
1. Patients >80 years of age 2. Patient requiring domiciliary oxygen 3. Anticipated to require a change in systemic therapy within the next 60 days 4. Active cardiac disease, defined as one or more of the following: occurring <6 months from informed consent - - Uncontrolled or unstable angina - Uncontrolled arrhythmias, or arrhythmias deemed clinically significant by the investigator - Myocardial infarction or cardiac stenting less than 6 months earlier or angioplasty - Uncontrolled or symptomatic congestive heart failure 5. Significant peripheral arterial disease (Ankle brachial index < 0.50) 6. Chronic obstructive lung disease (Pulmonary Function Test within the past 6 months with FEV1 < 40%) 7. Severe musculoskeletal condition 8. Symptomatic psychological or psychiatric condition which would preclude adherence to study protocol 9. In patients with known bone metastases, patients with lytic metastatic lesions involving the long bones will be excluded 10. Patients who are already participating in an established routine of physical activity or structured exercise program of greater than or equal to 30 minutes, 2 to 3 times/week.
Outcome results
None listed