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Completed

NCT Number: NCT03824860

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.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Yoga

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Oncology Nursing Society

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2019
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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