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Chemotherapy-induced Peripheral NeuropathyNCT03824860

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

A study testing Yoga in people with Chemotherapy-induced Peripheral Neuropathy and Yoga, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
6 Aug 2019to 18 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -≥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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in 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.

Read the 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.

Being tested
Yoga
Keywords
Chemotherapy-induced Peripheral Neuropathy, Yoga, Chronic Pain, Neuropathic Pain
Medical subject headings
Chronic Pain, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YogaBehavioural

    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
Study groups in NCT03824860
Study groupRoleWhat they receive
Yoga ProgramExperimentalEight-weeks, therapist and self-guided yoga
Receives: Behavioral: Yoga
Treatment as usualNo interventionControl group participants will continue to receive usual care and symptom management strategies from clinicians during the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants recruited to participate in the study

    Feasibility of participant recruitment to the study

    Measured: From enrollment to end of treatment at 8 weeks.

  2. Frequency of yoga practice by participants

    Feasibility of participant adherence to the yoga intervention

    Measured: From enrollment to end of treatment at 8 weeks.

  3. Frequency of outcome assessments completed by participants.

    Feasibility of participant adherence to outcome assessments

    Measured: From enrollment to end of treatment at 8 weeks.

Secondary outcomes (9)

  1. Acceptability and Satisfaction with Participation in Yoga Intervention

    We will use semi-structured interviews to gain information about participants' experience with the yoga program

    Measured: At the end of treatment, 8 weeks after enrollment

  2. 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.

    Measured: At the time of enrollment and at the end of treatment, 8 weeks after enrollment

  3. 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.

    Measured: From enrollment to end of treatment at 8 weeks.At the time of enrollment and at the end of treatment, 8 weeks after enrollment

  4. 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.

    Measured: At the time of enrollment and at the end of treatment, 8 weeks after enrollment

  5. 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.

    Measured: At the time of enrollment and at the end of treatment, 8 weeks after enrollment

  6. 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.

    Measured: At the time of enrollment and at the end of treatment, 8 weeks after enrollment

  7. 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.

    Measured: At the time of enrollment and at the end of treatment, 8 weeks after enrollment

  8. 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.

    Measured: At the time of enrollment and at the end of treatment, 8 weeks after enrollment

  9. 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.

    Measured: At the time of enrollment and at the end of treatment, at 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2019
  2. Study start6 Aug 2019
  3. Primary completion8 Feb 2021
  4. Study completion18 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03824860
Sponsor's protocol ID
18-578
Status last verified
Mar 2022
First submitted
29 Jan 2019
Last updated
28 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 34524631

  • 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.

    PubMed 33772364

Questions about this trial

What is this clinical trial studying?

A study testing Yoga in people with Chemotherapy-induced Peripheral Neuropathy and Yoga, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants recruited to participate in the study (time frame: From enrollment to end of treatment at 8 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03824860, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.

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