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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824860
• Other study ID #: 18-578
• Status: Completed
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: February 18, 2021

Study information

• Verified date: March 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 18, 2021
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Chronic Pain
• Neuralgia
• Neuropathic Pain
• Peripheral Nervous System Diseases
• Yoga

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Oncology Nursing Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Frequency of yoga practice by participants	Feasibility of participant adherence to the yoga intervention	From enrollment to end of treatment at 8 weeks.
Primary	Frequency of outcome assessments completed by participants.	Feasibility of participant adherence to outcome assessments	From enrollment to end of treatment at 8 weeks.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.