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The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Trial Status: active
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.
Inclusion Criteria
English-proficient men and women aged >= 18 years
Free of oncologic disease or stable disease by clinical examination and history
Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment
Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia
Grade >= 1 sensory pain based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the Brief Pain Inventory (BPI)-Short Form (SF) average pain item over the past week
On a stable regimen (no change in three months) if taking anti-neuropathy or other pain medications and not taking acetyl-L-carnitine
Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period
Willing to adhere to all study-related procedures, including randomization to one of the three arms
Patient answers “Yes” to at least one factor in the question: “Do you think your balance, gait, posture, alignment, or flexibility has been affected by your experience of CIPN?”
Exclusion Criteria
Patients who have received physical therapy or practiced yoga for CIPN in the past 3 months. As patients who have received physical therapy or practiced yoga in this time period may already be experiencing the benefits of yoga/stretching therapy, we will exclude such patients
Additional locations may be listed on ClinicalTrials.gov for NCT05121558.
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.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center