Breast Neoplasms
Conditions
Keywords
exercise training, breast cancer, taxane chemotherapy, peripheral neuropathy, fatigue, autonomic function
Brief summary
This study is a randomized control cross over trial of exercise training during or after taxane-containing chemotherapy treatment for breast cancer. Forty-three women with stage I-III breast cancer will be randomized to immediate or delayed thrice weekly exercise training for 8-12 weeks. The immediate exercise group will exercise during taxane chemotherapy and the delayed group will start exercise 2 weeks after completion of treatment. This design will allow for an assessment of the effects of exercise vs usual care during treatment, plus a comparison of the training response during vs. after chemotherapy.
Detailed description
Purpose The purpose of this study is to evaluate the effects of aerobic and resistance exercise training relative to usual care during taxane-containing chemotherapy treatment for breast cancer. Hypotheses Relative to usual care, aerobic and resistance exercise training during taxane-containing chemotherapy treatment for breast cancer will: 1. mitigate the experience of patient reported outcomes 2. reduce medical management of taxane side effects and adverse events 3. attenuate autonomic dysfunction and maintain resting cardiovascular function and cardiovascular response to exercise 4\) Objectives The primary aim of this study is to determine whether aerobic and resistance exercise training during taxane-containing chemotherapy treatment reduces patient-reported side effects, medical management and clinical adverse events reported relative to usual care. The secondary aim is to determine the whether aerobic and resistance exercise training during taxane-containing chemotherapy attenuates the occurrence of indices of autonomic dysfunction relative to usual care. 5\) Research methods This study is a randomized control trial with crossover. The intervention consists of aerobic, resistance and balance training three times a week. Forty-three women with a stage I-III breast cancer diagnosis who are scheduled to receive taxane-containing chemotherapy will be randomized to immediate or delayed exercise (stratified by treatment protocol). Potential participants will be referred by oncologist referral, or will be self-referred by recruitment posters, social media or word of mouth. 6\) Statistical analysis The primary outcome measure is the EORTC CIPN subscale of patient-reported symptoms related to neurotoxic chemotherapy. Secondary outcome measures include measures of autonomic dysfunction including heart rate and blood pressure variability, and medical management of taxane-related side effects, and clinical adverse events related to treatment. The chemotherapy-induced peripheral neuropathy (CIPN) sub-scale of the EORTC Quality of life Questionnaire is used as the primary outcome measure to determine sample size. G\*Power 3.0.10 was used to estimate sample size for independent t-tests between the two groups (at the 2-week post chemotherapy time point). At thirty-six participants, we will have 80% power to detect a medium (d=0.6) effect size in the EORTC CIPN-20 subscale at an alpha of 0.05 (one-tailed) . An additional 20% will be recruited to allow for dropout or non-adherence, making the final total sample size goal 43 participants. Baseline characteristics and outcome measures of the two groups will be compared with independent t-tests. To assess the effect of the exercise intervention during treatment, independent t-tests will be used to compare the outcome measures at two weeks post completion of taxane chemotherapy if no difference exists between groups baseline measures. For the exercise group, all outcome measures at time point 2 will be compared to time point 3 using paired t-tests to assess maintenance over time. Independent t-tests will first be used to determine whether significant differences exists between groups for the three exploratory measure time points. If no differences exist, all data will be combined, and analyzed with a repeated measures analysis of variance to determine whether differences exist.
Interventions
OTHERExercise
Moderate intensity aerobic and resistance training. Five minutes each of warm-up, cool-down, balance and flexibility will also be performed.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Born female * Age 19 or older * Histologically confirmed stage I-IIIA breast cancer diagnosis * Scheduled to receive neoadjuvant or adjuvant taxane-containing chemotherapy * Willing and able to attend baseline assessment prior to first taxane-containing treatment * Have reliable transportation to attend our exercise gym located near the Vancouver BCCA three times weekly for 8-13 weeks * Be able to read and communicate in English * Treating medical oncologist approval to participate
Exclusion criteria
* Receipt of further chemotherapy treatments after taxane-containing treatments * Stage IV cancer * Acute or uncontrolled health conditions including heart disease, respiratory disease (COPD or severe asthma) * Diagnosis of diabetes at any time * Personal history of neurological disorder * Mobility issues that require a mobility aid or that prevent exercise on a bike, treadmill, or elliptical (includes orthopedic injury or arthritis that result in inability to exercise) * Body mass index ≥40 kg/m2 * Previously received chemotherapy or thoracic radiation treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change with treatment and maintenance post treatment in patient-reported taxane-related symptoms via the EORTC CIPN subscale | 14-0 days pre taxane chemotherapy, 1-2 weeks after completion of half of planned taxane chemotherapy treatments, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion of taxane chemotherapy | European Organization for Research and Treatment of Cancer CIPN subscale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants requiring medical management of taxane side effects | Will be extracted from medical records 0-6 months after completion of chemotherapy | Prescription of medications, dose delays, dose reductions will be abstracted from cancer treatment records |
| Change with treatment and maintenance post treatment of heart rate variability | 14-0 days pre taxane chemotherapy, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion taxane chemotherapy | Electrocardiography will be used to assess heart rate variability during 10 minutes of supine rest |
| Change with treatment and maintenance post treatment of blood pressure variability | 14-0 days pre taxane chemotherapy, 1-2 weeks after completion of half of planned taxane chemotherapy treatments, 2 weeks post completion of taxane chemotherapy, 10-15 weeks post completion of taxane chemotherapy | A Finometer will be used to assess blood pressure variability from supine to standing posture |
| Number of participants with clinical reporting of adverse events during taxane-chemotherapy treatment | Will be extracted from medical records 0-6 months after completion of chemotherapy | Oncological treatment notes will be reviewed for clinical notation of adverese events during taxane treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change with treatment and maintenance post treatment of aerobic fitness via estimated peak oxygen consumption | 14-0 days pre taxane chemotherapy, 2 weeks post taxane chemotherapy, 10-15 weeks post taxane chemotherapy | Peak oxygen consumption be estimated from incremental cycle ergometer test |
| Change with treatment and maintenance post treatment of lower body muscular strength via estimated 1-repetition maximum leg press | 14-0 days pre taxane chemotherapy, 2 weeks post taxane chemotherapy, 10-15 weeks post taxane chemotherapy | Lower body strength be assessed by estimated 1 repetition maximum leg press |
| Change with treatment and maintenance post treatment of upper body muscular strength via handgrip strength | 14-0 days pre taxane chemotherapy, 2 weeks post taxane chemotherapy, 10-15 weeks post taxane chemotherapy | Handgrip strength will be assessed via handgrip dynamomemeter |
| Change during treatment and post treatment in cancer-related fatigue via revised Piper Fatigue Scale | 14-0 days pre taxane chemotherapy, 0-3 days pre chemo cycle 3, 3-5 days post chemo cycle 3, 0-3 days pre chemo cycle 4, 2 weeks post taxane chemotherapy, 10-15 weeks post taxane chemotherapy | Revised Piper Fatigue Scale will be administered electronically to assess change with the intervention but also across one cycle (third) of chemotherapy to investigate patterns in fatigue |
| Change in pain with treatment and improvement post treatment via Brief Pain Inventory | 14-0 days pre taxane chemotherapy, 2 weeks post taxane chemotherapy, 10-15 weeks post taxane chemotherapy | The Brief Pain Inventory will be administered electronically |
Countries
Canada
Outcome results
None listed