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

Not Applicable

Completed

• Conditions: Breast Cancer; Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy
• Interventions: Behavioral: Aerobic exercise; Behavioral: Iyengar yoga

• Registration Number: NCT04075097
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-31
• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-30
• Status Verified: 2019-12
• Primary Completion: 2020-02-03
• Study Completion: 2020-02-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aerobic exercise	Aerobic exercise	44 minutes of moderate intensity walking on a treadmill.
Yoga	Iyengar yoga	44 minutes of Iyengar yoga.

Primary Outcome Measures

Name	Time	Method
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.
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."

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Wisconsin-Madison Natatorium; 🇺🇸 Madison, Wisconsin, United States