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

NCT04075097 | Completed

• 4 other identifiers: 2018-1518A176000EDUC/KINESIOLOGY/KINESIOLOGUW18057
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Chemotherapy-induced Peripheral Neuropathy; Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

44 minutes of moderate intensity walking on a treadmill.

Behavioral: Aerobic exercise

Yoga

EXPERIMENTAL

44 minutes of Iyengar yoga.

Behavioral: Iyengar yoga

Interventions

Aerobic exercise BEHAVIORAL

1 session

Aerobic exercise

Iyengar yoga BEHAVIORAL

1 session

Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• American College of Sports Medicine: collaborator

Study Sites (1)

University of Wisconsin-Madison Natatorium

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neuralgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kelli Koltyn, PhD

  Professor of Kinesiology- Exercise Psychology, University of Wisconsin-Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study is an acute, single group, crossover pilot study where participants will complete two different experimental conditions: aerobic exercise and yoga.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: July 31, 2019
• Primary Completion: February 3, 2020
• Study Completion: February 3, 2020
• Last Updated: March 20, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)