Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study

NCT03824860 | Completed

• 1 other identifier: 18-578
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Yoga; Chronic Pain; Neuropathic Pain

Keywords

Chemotherapy-induced Peripheral Neuropathy; Yoga; Chronic Pain; Neuropathic Pain

Outcome Measures

Primary Outcomes (3)

• Number of participants recruited to participate in the study

  Feasibility of participant recruitment to the study

  From enrollment to end of treatment at 8 weeks.

• Frequency of yoga practice by participants

  Feasibility of participant adherence to the yoga intervention

  From enrollment to end of treatment at 8 weeks.

• Frequency of outcome assessments completed by participants.

  Feasibility of participant adherence to outcome assessments

  From enrollment to end of treatment at 8 weeks.

Secondary Outcomes (9)

• Acceptability and Satisfaction with Participation in Yoga Intervention

  At the end of treatment, 8 weeks after enrollment

• Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity

  At the time of enrollment and at the end of treatment, 8 weeks after enrollment

• Chemotherapy-Induced Peripheral Neuropathy Severity

  From enrollment to end of treatment at 8 weeks.At the time of enrollment and at the end of treatment, 8 weeks after enrollment

• Pain Interference

  At the time of enrollment and at the end of treatment, 8 weeks after enrollment

• Sleep-Related Impairment

  At the time of enrollment and at the end of treatment, 8 weeks after enrollment

Study Arms (2)

Yoga Program

EXPERIMENTAL

Eight-weeks, therapist and self-guided yoga

Behavioral: Yoga

Treatment as usual

NO INTERVENTION

Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study.

Interventions

Yoga BEHAVIORAL

Participants will attend at least one group class per week (in-person or Zoom) and practice one self-guided yoga video class at home on their own per week, over eight weeks Participants may choose to attend "Flow Yoga" and/or "Chair Flow Yoga" classes. These classes will be videotaped and made available to participants electronically. Classes consist of: * guided breathing exercises, * upper and lower extremity stretching * structured postures and movements to improve balance and strength

Yoga Program

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age,
• self-report ≥ 4/10 worst chemotherapy-induced peripheral neuropathy pain over the past week,
• at least three months post neurotoxic chemotherapy completion
• signed informed consent,
• willingness to participate in all study activities
• speak/read English

You may not qualify if:

• prognosis of less than three months,
• documented peripheral neuropathy due to other causes (e.g., diabetes),
• planned receipt of neurotoxic chemotherapy during the study period,
• practice yoga \>45 minutes per week over the past six months,
• diagnosis or documented recent history of significant psychiatric comorbidity (i.e., psychosis, suicidal ideation, or substance abuse)
• clinician deems that the patient is physically/functionally unable to participate in a yoga program

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Oncology Nursing Society: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Knoerl R, Giobbie-Hurder A, Berfield J, Berry D, Meyerhardt JA, Wright AA, Ligibel JA. Yoga for chronic chemotherapy-induced peripheral neuropathy pain: a pilot, randomized controlled trial. J Cancer Surviv. 2022 Aug;16(4):882-891. doi: 10.1007/s11764-021-01081-z. Epub 2021 Sep 15.

  PMID: 34524631 DERIVED

• Knoerl R, Phillips CS, Berfield J, Woods H, Acosta M, Tanasijevic A, Ligibel J. Lessons learned from the delivery of virtual integrative oncology interventions in clinical practice and research during the COVID-19 pandemic. Support Care Cancer. 2021 Aug;29(8):4191-4194. doi: 10.1007/s00520-021-06174-0. Epub 2021 Mar 26.

  PMID: 33772364 DERIVED

MeSH Terms

Conditions

Chronic Pain; Neuralgia

Interventions

Yoga

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Robert Knoerl, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: August 6, 2019
• Primary Completion: February 8, 2021
• Study Completion: February 18, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Brigham and Women's Hospital - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)