Memorial Sloan Kettering Cancer Center is conducting a landmark phase III randomized controlled trial to evaluate yoga as a non-pharmacological intervention for chemotherapy-induced peripheral neuropathy (CIPN), a debilitating side effect that affects more than half of breast cancer survivors for years after treatment completion.
Study Design and Rationale
The three-arm trial compares virtual Hatha yoga classes against education control and usual care in cancer survivors experiencing chronic CIPN pain. Participants in the intervention arm receive twice-weekly one-hour yoga classes taught virtually by MSK instructors and practice yoga at home daily for eight weeks. The education control arm receives one-hour virtual education classes twice per week for eight weeks, while the usual care arm continues standard CIPN treatment.
CIPN represents a significant clinical challenge, with symptoms including pain, paresthesia, and muscle weakness that can lead to functional decline and reduced quality of life. Previous research revealed that more than half of breast cancer survivors experience persistent CIPN up to a mean duration of 5.6 years, which is associated with a doubled fall risk.
Primary and Secondary Endpoints
The study's primary endpoint is the Brief Pain Inventory-Short Form average pain item measured at weeks 8 and 24. Secondary outcomes encompass a comprehensive assessment battery including the Neuropathic Pain Scale, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity, Patient-Reported Outcomes Measurement Information System Global Health, Brief Fatigue Inventory, Insomnia Severity Index, Hospital Anxiety and Depression Scale, and Quality of Life Questionnaire of CIPN twenty-item scale.
Functional assessments and quantitative sensory testing are conducted at weeks 0, 4, 8, 12, 18, and 24 to evaluate changes in balance, fall risk, and sensory function.
Participant Eligibility and Enrollment
The trial targets 268 participants meeting specific eligibility criteria, including moderate-to-severe CIPN pain defined by a score of 4 or greater on a 0-10 numerical rating scale. Participants must have completed neurotoxic chemotherapy including platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment and maintained stable anti-neuropathy medication regimens for three months.
As of February 2023, researchers have enrolled 64 participants, with 35 in the yoga intervention arm, 15 in education control, and 14 in usual care control. The participant demographics show 89% female and 11% male participants, with 78% identifying as white, 16% as black or African American, 1% as Asian, and 5% as more than one race.
Promising Pilot Study Results
The current phase III trial builds on encouraging pilot study results (NCT03292328) that demonstrated yoga's potential benefits for CIPN management. The pilot study showed that yoga reduced CIPN-related symptoms and improved quality of life and functional reach scores compared to waitlist control, providing the scientific foundation for this larger definitive trial.
Clinical Significance
The study addresses an urgent clinical need for non-pharmacological approaches to CIPN management. Yoga, as a meditative movement therapy incorporating stretching, flexibility, and balance training, offers a potentially accessible intervention that could improve functional outcomes and reduce fall risk in cancer survivors dealing with chronic neuropathy symptoms.
The researchers anticipate completing enrollment by March 2025, with results expected to inform evidence-based recommendations for integrating yoga into comprehensive CIPN management strategies.
