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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03824860
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : March 11, 2021
Sponsor:
Collaborator:
Oncology Nursing Society
Information provided by (Responsible Party):
Robert Knoerl, PhD, RN, Dana-Farber Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Yoga Chronic Pain Neuropathic Pain Behavioral: Yoga Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study
Actual Study Start Date : August 6, 2019
Actual Primary Completion Date : February 8, 2021
Actual Study Completion Date : February 18, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants recruited to participate in the study [ Time Frame: From enrollment to end of treatment at 8 weeks. ]
    Feasibility of participant recruitment to the study

  2. Frequency of yoga practice by participants [ Time Frame: From enrollment to end of treatment at 8 weeks. ]
    Feasibility of participant adherence to the yoga intervention

  3. Frequency of outcome assessments completed by participants. [ Time Frame: From enrollment to end of treatment at 8 weeks. ]
    Feasibility of participant adherence to outcome assessments


Secondary Outcome Measures :
  1. Acceptability and Satisfaction with Participation in Yoga Intervention [ Time Frame: 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

  2. Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity [ Time Frame: 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.

  3. 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 ]
    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.

  4. Pain Interference [ Time Frame: 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.

  5. Sleep-Related Impairment [ Time Frame: 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.

  6. Anxiety assessed by the "Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety" [ Time Frame: 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.

  7. Depression assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression [ Time Frame: 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.

  8. Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue [ Time Frame: 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.

  9. Physical Function [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824860


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Oncology Nursing Society
Investigators
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Principal Investigator: Robert Knoerl, PhD Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by Robert Knoerl, PhD, RN, Dana-Farber Cancer Institute:
Informed Consent Form  [PDF] May 19, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Robert Knoerl, PhD, RN, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03824860    
Other Study ID Numbers: 18-578
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Knoerl, PhD, RN, Dana-Farber Cancer Institute:
Chemotherapy-induced Peripheral Neuropathy
Yoga
Chronic Pain
Neuropathic Pain
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuralgia
Chronic Pain
Pain
 Neurologic Manifestations
Neuromuscular Diseases
Nervous System Diseases