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

NCT ID: NCT04075097

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2020-02-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Aerobic exercise

44 minutes of moderate intensity walking on a treadmill.

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: BEHAVIORAL

1 session

Yoga

44 minutes of Iyengar yoga.

Group Type: EXPERIMENTAL

Iyengar yoga

Intervention Type: BEHAVIORAL

1 session

Interventions

Aerobic exercise

1 session

Intervention Type: BEHAVIORAL

Iyengar yoga

1 session

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American College of Sports Medicine

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelli Koltyn, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University of Wisconsin-Madison Natatorium

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A176000

Identifier Type: OTHER

Identifier Source: secondary_id

EDUC/KINESIOLOGY/KINESIOLOG

Identifier Type: OTHER

Identifier Source: secondary_id

UW18057

Identifier Type: OTHER

Identifier Source: secondary_id

2018-1518

Identifier Type: -

Identifier Source: org_study_id