Yoga in Improving Chronic Pain in Patients with Chemotherapy-Induced Peripheral Neuropathy

Status: Active

Description

This trial studies how well yoga works in improving painful chemotherapy-induced peripheral neuropathy that has persisted for at least three months after the completion of chemotherapy treatment. Yoga intervention may help patients with chronic painful chemotherapy-induced peripheral neuropathy by improving symptoms that co-occur with pain (such as fatigue, anxiety) and strength and balance.

Eligibility Criteria

Inclusion Criteria

  • Self-report >= 4/10 (and =< 9/10 maximum) worst CIPN 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 an average of > 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
  • Adults unable to consent
  • Prisoners
  • Pregnant women

Locations & Contacts

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Contact: Robert J Knoerl
Email: Robert_knoerl@DFCI.Harvard.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I a. Determine the feasibility of yoga implementation by calculating participant recruitment, retention, and adherence rates in both groups of a randomized eight-week yoga trial.

I b. Explore intervention group participants’ perspectives of acceptability and satisfaction with the eight-week yoga intervention using semi-structured telephone interviews.

II. Characterize changes within and between study groups over the eight week intervention period with regard to worst chemotherapy-induced peripheral neuropathy (CIPN) pain intensity, CIPN severity, physical function, sleep-related impairment, anxiety, depression, and fatigue (SPADE symptoms), and salivary cortisol.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive therapist guided, in-person, group yoga for up to 2 classes weekly over 45 minutes each for 8 weeks.

GROUP II: Patients receive usual care and symptom management strategies from clinicians for 8 weeks. After completion of data collection in the 8-week study time frame, patients are encouraged to attend the yoga classes.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Robert J Knoerl

Trial IDs

Primary ID 18-578
Secondary IDs NCI-2019-01787
Clinicaltrials.gov ID NCT03824860