Somatic Yoga and Meditation for Cancer Survivors With Pain From Neuropathy

NCT03786055 | Completed DMC

• 1 other identifier: 2018.019
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• Sit and Reach (SR)

  The Sit and Reach Test (SR) is the most-widely used measure of hamstring and low back flexibility, examining the maximal reach an individual can make in a long-sitting position. The SR has established norms by the American College of Sports Medicine, with a score of 16 and 15 for adults 46-55 years old and 56-65 years old respectively in the 50th percentile. Individuals are asked to maintain a long-sit position on the floor while safely reaching forward as far as possible with their shoes removed, feet flat against the table, and legs straight. Three trials are averaged and higher scores indicate greater flexibility.

  Change from baseline flexibility at 8 weeks

• Forward Reach (FR)

  The Functional Reach test (FR) test examines the balance of individuals with respect to the patient's limit of stability. Each participant is instructed to flex the test arm forward to 90˚ and to reach forward as far as possible before taking a step. The reach is determined by the total excursion of the third metacarpal from the starting point to the point just before balance is lost. An average of 3 measurements is used as the final score. FR has demonstrated strong reliability and validity for measuring postural control in reaching forward during standing. The FR test has shown criterion validity, predictive validity, test-retest reliability, and inter-rater reliability for younger and older adults. It has also been shown to possess predictive validity for falls.

  Change from baseline balance at 8 weeks

• Timed Up and Go (TUG)

  The Timed Up and Go (TUG) is a standardized test that measures physical function in sitting to standing, walking and returning to the seated position. Participants are instructed to stand up from a chair, walk three meters as quickly and safely as possible, turn around, walk back and sit down. The test is timed and longer time indicates worse performance. Nine seconds is the cutoff for high risk of falls.

  Change from baseline walking speed at 8 weeks

Secondary Outcomes (6)

• Brief Pain Inventory (BPI)

  Change from baseline pain at 8 weeks

• Patient Neurotoxicity Scale (PNQ)

  Change from baseline sensation and strength at 8 weeks

• Perceived Stress Scale (PSS)

  Change from baseline stress at 8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline sleep at 8 weeks

• Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx)

  Change from baseline quality of life at 8 weeks

Other Outcomes (2)

• Vibration Sense - Biothesiometer

  Change from baseline sensation at 8 weeks

• Salivary Cortisol

  Change from baseline salivary cortisol at 8 weeks

Study Arms (1)

Somatic Yoga and Meditation (SYM)

EXPERIMENTAL

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.

Behavioral: Somatic Yoga and Meditation (SYM)

Interventions

Somatic Yoga and Meditation (SYM) 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.

Also known as: Yoga4CIPN (Y4CIPN)

Somatic Yoga and Meditation (SYM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stockton University: lead

Study Sites (2)

Leadership Studio

Atlantic City, New Jersey, 08401, United States

Location

Bacharach Institute for Rehabilitation

Pomona, New Jersey, 08025, United States

Location

Related Publications (5)

• 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.

  PMID: 27237580 BACKGROUND

• 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.

  PMID: 29343927 BACKGROUND

• 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.

  PMID: 22385567 BACKGROUND

• 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.

  PMID: 21733988 BACKGROUND

• 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.

  PMID: 31131640 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Meditation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mary Lou Galantino, PT, PhD

  Stockton University - Program in Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 24, 2018
• Study Start: June 4, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

US (2)