Abstract OT1-08-01: A pilot randomized usual care controlled study of yoga for persistent chemotherapy-induced peripheral neuropathy (CIPN) in breast and gynecological cancer survivors
Authors: Zhi WI , Leeolou MC , Piulson L , Chen P , Patterson C , Paul T , Patil S , Mao JJ , Bao T 
Published: May 2019

Background: CIPN is a common, painful, and debilitating side effect of many standard chemotherapy regimens. Patients with CIPN typically experience paresthesia (tingling, numbness), pain, and muscle weakness, and may exhibit significant functional decline and diminished quality of life. Our prior study showed that more than half of breast cancer survivors experience persistent CIPN up to a mean duration of 5.6 years and that this symptom is associated with a doubled fall risk. There is an urgent need to identify nonpharmacological approaches to reduce CIPN symptoms and improve cancer survivors' functional outcomes. Yoga is a mind-body modality that includes stretching, flexibility, and balance training; however, little is known about its effects on symptoms and functional outcomes among cancer survivors with CIPN.

Trial Design: We are conducting a two-arm pilot randomized usual care controlled trial in breast and gynecological cancer survivors at Memorial Sloan Kettering Cancer Center (MSK), New York, NY. Eligible subjects in the intervention arm receive one-hour Hatha Yoga classes taught twice weekly for eight weeks, and practice home-based yoga for a total of 12 weeks. Subjects in the wait list control (WLC) arm continue usual care for 12 weeks, followed by eight weeks of yoga classes and home-based yoga.

Eligibility Criteria: 1) Patients with a primary diagnosis of stage I-III breast, ovarian, uterine, or endometrial cancer; 2) moderate to severe CIPN, defined by four or greater on a 0–10 Numeric Rating Scale (NRS); 3) completion of neurotoxic chemotherapy at least three months prior; 4) no changes in anti-neuropathy medications within three months of enrollment; and 5) an ECOG performance status of 0–2.

Specific Aims: The primary endpoint is safety, feasibility, and NRS changes at eight weeks (end of treatment). The secondary endpoints include the Neuropathic Pain Scale (NPS) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) at eight, 12, and 20 weeks.

Statistical Methods: We will accrue 40 patients to get 36 patients evaluable for the primary endpoint at eight weeks. Using an ANCOVA analysis with a sample size of 36, we will be able to detect an effect size of 00.58 standard deviations (SD) of NRS (moderate effect size) between yoga and WLC assuming a NRS correlation between pre- and post-yoga of 0.5 SD. If we assume a 10% dropout rate based on our recently completed trial, we will need to recruit 20 subjects per arm (total of 40) to fall within the precision noted in the sample size calculation. We recognize that the sample size calculation was based on detecting a moderate effect between yoga and WLC and may miss small but clinically meaningful effects that can be used to design a future trial that is sufficiently powered.

Present accrual and target accrual: 40 participants. We have accrued 25 participants as of June 2018 and anticipate accrual completion by October 2018.

Citation Format: Zhi WI, Leeolou MC, Piulson L, Chen P, Patterson C, Paul T, Patil S, Mao JJ, Bao T. A pilot randomized usual care controlled study of yoga for persistent chemotherapy-induced peripheral neuropathy (CIPN) in breast and gynecological cancer survivors [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT1-08-01.