Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain

Study Overview
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Brief Summary
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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.

Official Title
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Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain

Conditions
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Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain

Intervention / Treatment
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* Behavioral: Aerobic exercise
* Behavioral: Iyengar yoga


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise<br>44 minutes of moderate intensity walking on a treadmill. | Behavioral: Aerobic exercise<br>* 1 session<br>|
| Experimental: Yoga<br>44 minutes of Iyengar yoga. | Behavioral: Iyengar yoga<br>* 1 session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neuropathic Pain Sensations as determined by VAS | 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. | 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. | 
| Change in cold pain threshold | The minimum cold temperature needed to elicit a pain response. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total mood disturbance (Profile of Mood States) | 65-item self-reported mood questionnaire that measures mood right now. Scores range from 0-200 with higher scores indicating higher mood disturbance. | 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. | 
| Change in plasma concentration of 2-Arachidonoylglycerol (2-AG) | Plasma concentration of 2-AG, one effector of the endocannabinoid system | 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. |