Clinical trial NCT03786055: Somatic Yoga and Meditation for Cancer Survivors With Pain From Neuropathy
Official title: Impact of Somatic Yoga and Meditation on Fall Risk, Function, and Quality of Life for Chemotherapy-Induced Peripheral Neuropathy Syndrome in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Pain
Chemotherapy Induced Peripheral Neuropathy
Function
Fall Risk
Balance
Quality of Life
Keywords: cancer survivor
pain
chemotherapy induced peripheral neuropathy
fall risk
quality of life
somatic yoga
meditation
Lead sponsor: Stockton University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Criteria for enrollment included cancer survivors age 18 or older; any type or stage of cancer, currently completed all treatment with no current evidence of disease; at least mild peripheral neuropathy symptoms (either sensory or motor) as rated on the Patient Neurotoxicity Questionnaire (PNQ), attributable to chemotherapy intervention as a component of cancer treatment. Exclusion criteria included active cancer disease or current cancer treatment; co-morbidities such a diabetes or prior history of peripheral neuropathy from any cause. All participants will be screened with the physical activity readiness questionnaire (PAR-Q) to determine the safety or possible risk of exercising based on health history, current symptoms and risk factors. Somatic yoga and meditation (SYM) will be provided during 16 sessions/8 weeks for 1.5 hours and participants will complete home-based SYM and journal entries.
Primary purpose: TREATMENT

Brief summary: Chemotherapy-induced peripheral neuropathy syndrome (CIPN) causes significant pain in hands and feet and is an adverse effect of treatment. Few non-pharmacological interventions have been tested and individuals experience CIPN symptoms years after treatment. This is the first study to explore a somatic yoga and meditation (SYM) intervention on functional outcomes and quality of life in cancer survivors.

Detailed description: Pain is a common symptom associated with cancer; 75-90% of cancer patients experience pain during their illness and up to 50% of that pain is undertreated. Unrelieved pain leads to increased levels of the stress hormone cortisol. Chemotherapy-induced peripheral neuropathy syndrome (CIPN) causes significant pain in hands and feet and is a common, adverse effect of several chemotherapeutic agents. It can lead to abrupt discontinuation of treatment, and severely affects the quality of life.

CIPN is a particularly important adverse effect because it may compromise the ability to tolerate chemotherapy and become a serious, long-lasting, and even permanent debility. CIPN symptoms may persist many years after treatment; together with worse function, greater disability, and more falls which is complicated by the aging process. Clinically, CIPN presents as deficits in sensory, motor, and function which develop in a glove and stocking distribution.

While chemotherapy improves the likelihood of disease-free survival, the result of CIPN may cause decreased walking speed and balance observed after the first chemotherapy cycle and progresses with cumulative exposure. These functional deficits are mirrored with increased symptom severity. CIPN is associated with potential fall risk with aging cancer survivors and increased functional disability.

Few interventions have been tested for impact from CIPN. Yoga is a popular movement therapy, often used by cancer survivors for symptom management. Several studies demonstrate the promising effects of yoga on sleep, fatigue and quality of life (QOL) in cancer survivors. However, no study has rigorously investigated its effects on CIPN and quality of life.

This study will explore the preliminary therapeutic effects of an 8-week somatic based yoga and meditation (SYM) program and 15-25 cancer survivors with CIPN will be enrolled into a small pilot study. This will include 16 sessions of yoga designed specifically to minimize injury, promote flexibility/ balance and to allow you to maximize their specific functional goals. All types of cancer diagnoses resulting in CIPN will be enrolled in a single arm feasibility trial. SYM will be provided twice a week for 8 weeks for 1.5 hours. You will complete surveys at the beginning and end of 8 weeks and receive a home-based SYM and write journal entries to determine your perspectives of the intervention.

Eligibility criteria: Inclusion Criteria:

* Cancer survivors 18 years or older
* Any type or stage of cancer
* Completed chemotherapy treatment
* Mild Peripheral Neuropathy Symptoms

Exclusion Criteria:

* Active cancer disease
* Currently receiving cancer treatment
* Diabetes
* Prior history of peripheral neuropathy from other disease
* Risk factors for exercise (measured by Patient Activity Readiness Questionnaire)

Primary outcomes:
measure: Sit and Reach (SR)
timeFrame: Change from baseline flexibility at 8 weeks
measure: Forward Reach (FR)
timeFrame: Change from baseline balance at 8 weeks
measure: Timed Up and Go (TUG)
timeFrame: Change from baseline walking speed at 8 weeks
Secondary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Change from baseline pain at 8 weeks
measure: Patient Neurotoxicity Scale (PNQ)
timeFrame: Change from baseline sensation and strength at 8 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: Change from baseline stress at 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline sleep at 8 weeks
measure: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx)
timeFrame: Change from baseline quality of life at 8 weeks
measure: Falls Efficacy Scale (FES)
timeFrame: Change from baseline fear of falling at 8 weeks
Other outcomes:
measure: Vibration Sense - Biothesiometer
timeFrame: Change from baseline sensation at 8 weeks
measure: Salivary Cortisol
timeFrame: Change from baseline salivary cortisol at 8 weeks
Locations:
city: Atlantic City
country: United States
facility: Leadership Studio
state: New Jersey
city: Pomona
country: United States
facility: Bacharach Institute for Rehabilitation
state: New Jersey
Study officials:
affiliation: Stockton University - Program in Physical Therapy
name: Mary Lou Galantino, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stout NL, Silver JK, Raj VS, Rowland J, Gerber L, Cheville A, Ness KK, Radomski M, Nitkin R, Stubblefield MD, Morris GS, Acevedo A, Brandon Z, Braveman B, Cunningham S, Gilchrist L, Jones L, Padgett L, Wolf T, Winters-Stone K, Campbell G, Hendricks J, Perkin K, Chan L. Toward a National Initiative in Cancer Rehabilitation: Recommendations From a Subject Matter Expert Group. Arch Phys Med Rehabil. 2016 Nov;97(11):2006-2015. doi: 10.1016/j.apmr.2016.05.002. Epub 2016 May 27.
citation: Agarwal RP, Maroko-Afek A. Yoga into Cancer Care: A Review of the Evidence-based Research. Int J Yoga. 2018 Jan-Apr;11(1):3-29. doi: 10.4103/ijoy.IJOY_42_17.
citation: Galantino ML, Greene L, Daniels L, Dooley B, Muscatello L, O'Donnell L. Longitudinal impact of yoga on chemotherapy-related cognitive impairment and quality of life in women with early stage breast cancer: a case series. Explore (NY). 2012 Mar-Apr;8(2):127-35. doi: 10.1016/j.explore.2011.12.001.
citation: Galantino ML, Desai K, Greene L, Demichele A, Stricker CT, Mao JJ. Impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgias. Integr Cancer Ther. 2012 Dec;11(4):313-20. doi: 10.1177/1534735411413270. Epub 2011 Jul 6.
citation: Galantino ML, Tiger R, Brooks J, Jang S, Wilson K. Impact of Somatic Yoga and Meditation on Fall Risk, Function, and Quality of Life for Chemotherapy-Induced Peripheral Neuropathy Syndrome in Cancer Survivors. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419850627. doi: 10.1177/1534735419850627.