Chemotherapy-induced Peripheral Neuropathy, Chronic Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Nerve Pain, Neuropathy, Neuropathy, Painful, Pain
Conditions
Keywords
Yoga, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain, Pain Management, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Cancer survivor, CIPN
Brief summary
The purpose of this study is to test whether yoga can reduce nerve pain caused by cancer treatment (chemotherapy-induced peripheral neuropathy, or CIPN). Participants will take one of three approaches: * Yoga classes * Educational sessions on the causes and impacts of CIPN, how yoga may help with CIPN, and how different therapies may help with CIPN * Usual care with standard-of-care medications for CIPN The researchers will compare how these different approaches affect participants' balance, their risk of falls, and their quality of life. This study will also measure how much yoga can help the reduced sense of touch caused by CIPN. The functional assessments Timed Up and Go (TUG) and Chair to Stand (CTS) can be safely completed either virtually and in-person and will be mandatory for all patients. The functional assessment Functional Reach Test (FRT) and Quantitative Sensory Testing (QST) assessments that can only be completed in-person are optional at these time points.
Interventions
OTHERYoga
Participants will have instructional yoga classes twice each week over the course of 8 weeks. Each yoga class will be 60 minutes, and it will be taught by an experienced yoga instructor. Participants will be provided with a home-based guided program for days classes are not held. Participants in the yoga group will also have the option to participate in a recorded final check-in session after they have completed their 16 yoga classes. The discussion facilitator will follow the Semi-Structured Interview Guide to further understand participants' experiences in the yoga group.
OTHEREducation control
Participants will have educational sessions over 8 weeks. The sessions will be on the causes and impact of Chemotherapy-Induced Peripheral Neuropathy (CIPN), how yoga may help with CIPN, and how different therapies may help with CIPN. To encourage participation and adherence, patients in the EC group will receive sixteen free yoga sessions after completing the study. Patients in the EC group will be asked to not go for their own yoga classes locally until their participation in the study is completed.
OTHERUsual care
Participants in the usual care control group will complete the same assessments as the other two arms. To encourage participation and adherence, patients in the UC group will receive sixteen free yoga sessions after completing the study. Patients in the UC group will be asked to not go for their own yoga classes locally until their participation in the study is completed.
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
The PI and investigators will be blinded to the patient's group assignment.
Intervention model description
3-arm parallel randomized controlled trial (RCT) comparing yoga to a non-physical education control (EC) and usual care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English-proficient men and women aged ≥18 years * Free of oncologic disease or 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 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 BPI-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 its benefits, we will exclude such patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga | up to 24 weeks | as measured by the Brief Pain Inventory-Short Form (BPI-SF) compared to EC and UC arms at week 8 response choices of 0 ("no pain") to 10 ("pain as bad as you can imagine"). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTing Bao, MD
Dana-Farber Cancer Institute
Outcome results
None listed