An interventional study of Somatic Yoga and Meditation (SYM) in Cancer Survivor, Pain and Chemotherapy Induced Peripheral Neuropathy, sponsored by Stockton University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-15.
Sponsored by Stockton University · Not applicable, Interventional, and Treatment
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 18 is below the median of 66 across 8,493 interventional studies indexed under Pain.
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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)
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline walking speed at 8 weeks
Brief Pain Inventory (BPI)
The BPI is a patient reported outcome measure that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. It responds to both behavioral and pharmacological pain interventions and takes 5 minutes to complete. Scoring algorithm: "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference. Reliability: Cronbach alpha reliability ranges from 0.77 to 0.91
Time frame: Change from baseline pain at 8 weeks
Patient Neurotoxicity Scale (PNQ)
Patient perception of sensation and weakness attributed to CIPN.The PNQ is two self-reflective questions and quantifies the symptoms (sensation) and perceived weakness from CIPN 1) Do you have numbness, pain, or tingling in your hands or feet? 2) Do you have weakness in your arms or legs? These two items are rated 1-5 on the following scale: 1 = No, 2 = Mild, 3 = Moderate, 4 = Moderate-to-Severe, and 5 = Severe. The PNQ total score ranges from 2 to 10, with a high total score indicating severe CIPN symptoms. A PNQ total score of 2 is defined as grade A; 3-4, as grade B; 5-6, as grade C; 7-8, as grade D; and 9-10, as grade E
Time frame: Change from baseline sensation and strength at 8 weeks
Perceived Stress Scale (PSS)
Each item is rated on a 5-point scale ranging from never (0) to almost always (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. ► Scores ranging from 0-13=low stress. ► Scores ranging from 14-26 = moderate stress. ► Scores ranging from 27-40 = high perceived stress.
Time frame: Change from baseline stress at 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time frame: Change from baseline sleep at 8 weeks
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx)
The FACT/GOG-Ntx contains 11 items scored from 0-4, and scores are summed for a range of 11-44. Questions on the Ntx subscale pertain to the feeling of weakness all over, numbness or tingling in the hands or feet, and difficulty buttoning their buttons. Reliability was measured using Cronbach alpha of greater than 0.7 and higher scores indicate greater severity of symptoms.
Time frame: Change from baseline quality of life at 8 weeks
Falls Efficacy Scale (FES)
The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
Time frame: Change from baseline fear of falling at 8 weeks
Vibration Sense - Biothesiometer
A calibrated biothesiometer will be used to measure vibration sense. Participants will be placed in a relaxed position in a chair and tested with the same script and application of the vibration unit to the proximal lower extremity where sensation is intact. Mid-plantar pad and the tip of the great toe will be tested via 2 trials per protocol and averaged. The amplitude is directly proportional to the square of the applied voltage and higher numbers indicate less perception of sensation.
Time frame: Change from baseline sensation at 8 weeks
Salivary Cortisol
Salivary cortisol will be collected using the Salivette device and standardized methodology with minimum invasiveness. Higher numbers indicate greater cortisol levels and higher stress
Time frame: Change from baseline salivary cortisol at 8 weeks
Plan to share: Undecided — Will share deidentified data along with analysis to build from pilot data findings to engage in larger randomized clinical trials.
Ran from Jun 2018 to primary completion in Jul 2019, 13 months.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 13 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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