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

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy, Yoga, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring Chemotherapy-induced Peripheral Neuropathy, Yoga, Chronic Pain, Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga Program

Treatment as usual

Arm Description

Eight-weeks, therapist and self-guided yoga

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

Outcomes

Primary Outcome Measures

Number of participants recruited to participate in the study
Feasibility of participant recruitment to the study
Frequency of yoga practice by participants
Feasibility of participant adherence to the yoga intervention
Frequency of outcome assessments completed by participants.
Feasibility of participant adherence to outcome assessments

Secondary Outcome Measures

Acceptability and Satisfaction with Participation in Yoga Intervention
We will use semi-structured interviews to gain information about participants' experience with the yoga program
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 29, 2019
Last Updated
March 25, 2022
Sponsor
Dana-Farber Cancer Institute
Collaborators
Oncology Nursing Society
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1. Study Identification

Unique Protocol Identification Number
NCT03824860
Brief Title
Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study
Official Title
Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
February 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Oncology Nursing Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy, Yoga, Chronic Pain, Neuropathic Pain
Keywords
Chemotherapy-induced Peripheral Neuropathy, Yoga, Chronic Pain, Neuropathic Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Program
Arm Type
Experimental
Arm Description
Eight-weeks, therapist and self-guided yoga
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants recruited to participate in the study
Description
Feasibility of participant recruitment to the study
Time Frame
From enrollment to end of treatment at 8 weeks.
Title
Frequency of yoga practice by participants
Description
Feasibility of participant adherence to the yoga intervention
Time Frame
From enrollment to end of treatment at 8 weeks.
Title
Frequency of outcome assessments completed by participants.
Description
Feasibility of participant adherence to outcome assessments
Time Frame
From enrollment to end of treatment at 8 weeks.
Secondary Outcome Measure Information:
Title
Acceptability and Satisfaction with Participation in Yoga Intervention
Description
We will use semi-structured interviews to gain information about participants' experience with the yoga program
Time Frame
At the end of treatment, 8 weeks after enrollment
Title
Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity
Description
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.
Time Frame
At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Title
Chemotherapy-Induced Peripheral Neuropathy Severity
Description
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.
Time Frame
From enrollment to end of treatment at 8 weeks.At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Title
Pain Interference
Description
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.
Time Frame
At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Title
Sleep-Related Impairment
Description
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.
Time Frame
At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Title
Anxiety assessed by the "Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety"
Description
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.
Time Frame
At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Title
Depression assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression
Description
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.
Time Frame
At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Title
Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue
Description
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.
Time Frame
At the time of enrollment and at the end of treatment, 8 weeks after enrollment
Title
Physical Function
Description
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.
Time Frame
At the time of enrollment and at the end of treatment, at 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knoerl, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
34524631
Citation
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.
Results Reference
derived
PubMed Identifier
33772364
Citation
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.
Results Reference
derived

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

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