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

Not Applicable

Completed

• Conditions: Chronic Pain; Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy; Yoga
• Interventions: Behavioral: Yoga

• Registration Number: NCT03824860
• Lead Sponsor: Dana-Farber Cancer Institute

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.

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 Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Study Start: 2019-08-06
• Primary Completion: 2021-02-08
• Study Completion: 2021-02-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga Program	Yoga	Eight-weeks, therapist and self-guided yoga

Primary Outcome Measures

Name	Time	Method
Frequency of yoga practice by participants	From enrollment to end of treatment at 8 weeks.	Feasibility of participant adherence to the yoga intervention
Number of participants recruited to participate in the study	From enrollment to end of treatment at 8 weeks.	Feasibility of participant recruitment to the study
Frequency of outcome assessments completed by participants.	From enrollment to end of treatment at 8 weeks.	Feasibility of participant adherence to outcome assessments

Secondary Outcome Measures

Name	Time	Method
Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue	At the time of enrollment and at the end of treatment, 8 weeks after enrollment	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.
Physical Function	At the time of enrollment and at the end of treatment, at 8 weeks.	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.
Anxiety assessed by the "Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety"	At the time of enrollment and at the end of treatment, 8 weeks after enrollment	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.
Acceptability and Satisfaction with Participation in Yoga Intervention	At the end of treatment, 8 weeks after enrollment	We will use semi-structured interviews to gain information about participants' experience with the yoga program
Pain Interference	At the time of enrollment and at the end of treatment, 8 weeks after enrollment	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.
Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity	At the time of enrollment and at the end of treatment, 8 weeks after enrollment	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.
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	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.
Sleep-Related Impairment	At the time of enrollment and at the end of treatment, 8 weeks after enrollment	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.
Depression assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression	At the time of enrollment and at the end of treatment, 8 weeks after enrollment	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.

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States