Clinical trial NCT04075097: Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain
Official title: Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Chemotherapy-induced Peripheral Neuropathy
Neuropathic Pain
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: American College of Sports Medicine
First posted: 2019-08-30
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Neuropathic Pain Sensations as determined by VAS
timeFrame: 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.
measure: Change in cold pain threshold
timeFrame: 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 outcomes:
measure: Change in total mood disturbance (Profile of Mood States)
timeFrame: 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.
measure: Change in plasma concentration of 2-Arachidonoylglycerol (2-AG)
timeFrame: 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.
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison Natatorium
state: Wisconsin
Study officials:
affiliation: Professor of Kinesiology- Exercise Psychology, University of Wisconsin-Madison
name: Kelli Koltyn, PhD
role: PRINCIPAL_INVESTIGATOR
References: