This phase III trial compares the effect of yoga to educational sessions for reducing nerve pain caused by cancer treatment (chemotherapy-induced peripheral neuropathy). Yoga is a type of exercise that combines physical postures with breathing techniques and meditation to strengthen the body and improve flexibility. Yoga also helps stimulate blood flow and muscle activation to improve balance and body movement. Yoga may help reduce inflammation (pain or swelling) and psychological stress, and improve balance and quality of life in patients with chemotherapy-induced peripheral neuropathy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05121558.
PRIMARY OBJECTIVE:
I. To determine the efficacy of an eight-week yoga treatment course on chemotherapy-induced peripheral neuropathy (CIPN) pain among cancer survivors with moderate to severe CIPN pain.
SECONDARY OBJECTIVES:
I. To evaluate the effect of yoga versus education control (EC) and usual care (UC) on improving balance and reducing fall risks.
II. To evaluate the effect of yoga versus EC and UC on improving quality of life (QoL).
TERTIARY OBJECTIVE:
I. To explore the effects of yoga on improving sensory function.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients participate in 60-minute yoga classes twice weekly (BIW) for 8 weeks. Patients may optionally participate in a facilitated discussion following completion of the 16 yoga classes.
GROUP II: Patients participate in 60-minute education sessions BIW consisting of causes and impacts of CIPN, how yoga may help with CIPN, and how different therapies may help with CIPN for 8 weeks.
GROUP III: Patients receive standard of care for 8 weeks.
After completion of study treatment, patients are followed up at 12, 18, and 24 weeks.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorTing Bao