Somatic Yoga and Meditation for Cancer Survivors With Pain From Neuropathy

NCT ID: NCT03786055

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2019-07-31

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.

Conditions

Cancer Survivor; Pain; Chemotherapy Induced Peripheral Neuropathy; Function; Fall Risk; Balance; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Somatic Yoga and Meditation (SYM)

Participants will engage in 16 sessions of somatic yoga and meditation with appropriate props as needed over 8 weeks and continue with a home practice. Application of SYM throughout activities of daily living is reinforced. All sessions are facilitated by trained yoga therapists.

Group Type: EXPERIMENTAL

Somatic Yoga and Meditation (SYM)

Intervention Type: BEHAVIORAL

A Hanna somatics and somatic yoga and meditation (SYM) protocol was designed to address sensory-motor amnesia and reduce trauma which creates reflex patterns that lead to chronic muscular contractions. The movements use voluntary muscular contraction and slow controlled eccentric contraction, with the constant focus on sensation to increase the resting length of muscles. Movements are performed slowly and gently with the least possible effort and are never forced. The protocol is endorsed by the US Army Surgeon General as treatment for chronic pain. The meditations are trauma informed and evidence based supporting pain modulation, healing and well-being.

Interventions

Somatic Yoga and Meditation (SYM)

A Hanna somatics and somatic yoga and meditation (SYM) protocol was designed to address sensory-motor amnesia and reduce trauma which creates reflex patterns that lead to chronic muscular contractions. The movements use voluntary muscular contraction and slow controlled eccentric contraction, with the constant focus on sensation to increase the resting length of muscles. Movements are performed slowly and gently with the least possible effort and are never forced. The protocol is endorsed by the US Army Surgeon General as treatment for chronic pain. The meditations are trauma informed and evidence based supporting pain modulation, healing and well-being.

Intervention Type: BEHAVIORAL

Other Intervention Names

Yoga4CIPN (Y4CIPN)

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stockton University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Lou Galantino, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Stockton University - Program in Physical Therapy

Locations

Leadership Studio

Atlantic City, New Jersey, United States

Bacharach Institute for Rehabilitation

Pomona, New Jersey, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27237580 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29343927 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22385567 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21733988 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31131640 (View on PubMed)

Other Identifiers

2018.019

Identifier Type: -

Identifier Source: org_study_id