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

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Neuropathic Pain; Yoga; Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Behavioral: Yoga

Detailed Description

This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy. The investigators will also explore participants' perceptions of acceptability and satisfaction with the yoga intervention. Lastly, the investigators will examine changes in chemotherapy-induced peripheral neuropathy severity, physical function, sleep-related impairment, fatigue, anxiety, depression, and pain following the eight-week yoga intervention.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-≥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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga Program; Eight-weeks, therapist and self-guided yoga	Behavioral: Yoga; 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
No Intervention: Treatment as usual; Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability and Satisfaction with Participation in Yoga Intervention	We will use semi-structured interviews to gain information about participants' experience with the yoga program	At the end of treatment, 8 weeks after enrollment
Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity	Change in 0 - 10 numerical rating scale of worst chemotherapy-induced peripheral neuropathy pain (via 7-day pain diary) from enrollment to end of treatment at 8 weeks. Total scores range from 0 - 10, with higher scores representing worse pain.	At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Chemotherapy-Induced Peripheral Neuropathy Severity	Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale-20 score from enrollment to end of treatment at 8 weeks. Total scores range from 0 - 100, with higher scores representing worse 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	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 41.6 - 75.6, with higher scores representing worse pain interference.	At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Sleep-Related Impairment	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment 8a score from enrollment to the end of treatment at 8 weeks. Total scores range from 30.0 - 80.1 with higher scores representing worse sleep-related impairment.	At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Anxiety assessed by the "Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety"	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 40.3 - 81.6, with higher scores representing worse anxiety.	At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Depression assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 41.0 - 79.4, with higher scores representing worse depression.	At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 33.7 - 75.8, with higher scores representing worse fatigue.	At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Physical Function	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 22.5 - 57.0, with higher scores representing better physical function.	At the time of enrollment and at the end of treatment, at 8 weeks.

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Oncology Nursing Society
• Investigators: Principal Investigator: Robert Knoerl, PhD, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Actual): February 8, 2021
• Study Completion (Actual): February 18, 2021

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Yoga; Chronic Pain; Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Chronic Pain; Neuralgia; Peripheral Nervous System Diseases
• Other Study ID Numbers: 18-578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Robert Knoerl, PhD; Study PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Brigham and Women's Hospital - Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No