Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain
Conditions
Brief summary
This study evaluates the acute effect of aerobic exercise and yoga on pain, plasma levels of endocannabinoids, and mood (i.e., mood disturbance and anxiety). Participants will complete three separate sessions on different days. The first session is a familiarization session in which participants complete questionnaires and are familiarized with the experimental protocols. During the second and third sessions, outcomes are measured before and after the participants complete either 44 minutes of moderate aerobic exercise (i.e., walking on a treadmill) or 44 minutes of yoga.
Interventions
BEHAVIORALAerobic exercise
1 session
BEHAVIORALIyengar yoga
1 session
Sponsors
American College of Sports Medicine
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
The proposed study is an acute, single group, crossover pilot study where participants will complete two different experimental conditions: aerobic exercise and yoga.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of breast cancer (stage 0-III), * no evidence of active disease (i.e., recurrence, bone metastases, etc), * presence of painful polyneuropathy, with onset coinciding or developing after receiving chemotherapy agents that in the opinion of the research team is likely to have caused such symptoms, * at least six months since last active cancer treatment, with no further planned treatment (Note. active treatment is defined as surgery, chemotherapy, or radiation), * the participant agrees to use the safety stop feature on the treadmill if needed, * at least 18 years of age, * and their physicians has provided consent for them to participate in yoga and aerobic exercise sessions.
Exclusion criteria
* Undergoing current chemotherapy or radiation treatment for cancer, * taking anticoagulant therapy, * uncontrolled medical conditions (i.e., uncontrolled hypertension, heart disease, stage 4 liver disease, end-stage renal disease, end-stage pulmonary disease, etc), * stroke or myocardial infarction in the past 6 months, * being pregnant or planning to become pregnant, * severe mobility constraints (e.g., confined to a wheelchair), * having a history of light headedness or fainting during blood draws or physical activity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuropathic Pain Sensations as determined by VAS | This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study. | Visual analog scales (VAS) will be used to assess the intensity of the following sensations specific to neuropathic pain: pins and needles, tingles, stinging, and electrical pain sensations. The VAS is measured on a 100mm scale ranging from No Pain to Worst Imaginable Pain. |
| Change in cold pain threshold | This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study. | The minimum cold temperature needed to elicit a pain response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total mood disturbance (Profile of Mood States) | This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study. | 65-item self-reported mood questionnaire that measures mood right now. Scores range from 0-200 with higher scores indicating higher mood disturbance. |
| Change in plasma concentration of 2-Arachidonoylglycerol (2-AG) | This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study. | Plasma concentration of 2-AG, one effector of the endocannabinoid system |
Countries
United States
Outcome results
None listed