Clinical trial NCT03824860: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Yoga
Chronic Pain
Neuropathic Pain
Keywords: Chemotherapy-induced Peripheral Neuropathy
Yoga
Chronic Pain
Neuropathic Pain
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oncology Nursing Society
First posted: 2019-01-31
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of participants recruited to participate in the study
timeFrame: From enrollment to end of treatment at 8 weeks.
measure: Frequency of yoga practice by participants
timeFrame: From enrollment to end of treatment at 8 weeks.
measure: Frequency of outcome assessments completed by participants.
timeFrame: From enrollment to end of treatment at 8 weeks.
Secondary outcomes:
measure: Acceptability and Satisfaction with Participation in Yoga Intervention
timeFrame: At the end of treatment, 8 weeks after enrollment
measure: Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity
timeFrame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
measure: Chemotherapy-Induced Peripheral Neuropathy Severity
timeFrame: From enrollment to end of treatment at 8 weeks.At the time of enrollment and at the end of treatment, 8 weeks after enrollment
measure: Pain Interference
timeFrame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
measure: Sleep-Related Impairment
timeFrame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
measure: Anxiety assessed by the "Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety"
timeFrame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
measure: Depression assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression
timeFrame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
measure: Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue
timeFrame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
measure: Physical Function
timeFrame: At the time of enrollment and at the end of treatment, at 8 weeks.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Robert Knoerl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.