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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075097
• Other study ID #: 2018-1518
• Secondary ID: A176000EDUC/KINE
• Status: Completed
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: February 3, 2020

Study information

• Verified date: December 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 3, 2020
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy-induced Peripheral Neuropathy
• Neuralgia
• Neuropathic Pain
• Peripheral Nervous System Diseases

Intervention

Behavioral:
• Aerobic exercise
1 session
• Iyengar yoga
1 session

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison Natatorium	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	American College of Sports Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.