Testing an Herbal Pain Relief Patch to Reduce Pain in Cancer Survivors

Study Overview
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Brief Summary
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The purpose of this study is to find out whether Tibetree Pain Relieving Plaster, an herbal pain relief patch, may be able to reduce this pain. Tibetree Pain Relieving Plaster is available as an over-the-counter (non-prescription) treatment for the temporary relief of minor aches and pains in muscles and joints. This study is the first to test this treatment in people who have had cancer.

Official Title
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Tibetree Pain-Relieving Plaster for Musculoskeletal Pain Among Cancer Survivors

Conditions
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Cancer, Remission

Intervention / Treatment
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* Drug: Tibetree Pain Relieving Plaster
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years or older A diagnosis of cancer with no restrictions placed on type of cancer or stage. Eligibility criteria will not be restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is sufficient for other study sites Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment or maintenance targeted therapies will not be excluded). Patients currently have no evidence of disease Ambulatory (Karnofsky functional score of ≥ 60) Having a focused location of regional musculoskeletal pain (e.g. joints, extremities, back, neck) that can be covered by one patch of PRP Worst pain score (numeric pain rating scale) 5 or above in the preceding week Pain for at least 3 months and at least 15 days with pain in the preceding 30 days; and willingness to adhere to and understanding of all study-related procedures, including randomization to one of the two possible choices Able to understand informed consent and provide signed informed consent form Exclusion Criteria: Patients with non-musculoskeletal pain syndromes (headache, facial pain, chest pain, visceral abdominal pain) will be excluded if these are the sole source of pain but can be present as co-morbid conditions as long as a patient has a primary musculoskeletal pain condition defined as above. Patients have generalized musculoskeletal pain such as fibromyalgia Use of corticosteroid drugs by any route of administration within 30 days Patients with significant self-reported skin disorders Patients with open wounds, infections, skin trauma at skin overlying area of pain Patients with documented history of skin sensitivity to adhesive or allergic reaction to other patches or topical analgesics Patients with documented skin allergic reaction to plants or herbs Patients who are in active treatment (chemotherapy, surgery, radiotherapy) Plan to change or initiate other pain medications or interventions (e.g. physical therapy, acupuncture, injection). Patients may remain on their current pain regimen.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-center, two-arm, randomized, placebo-controlled trial comparing Tibetree PRP with a placebo control plaster.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tibetree pain relieving plaster<br>Participants with chronic musculoskeletal pain for ≥ 3 months and with BPI worst pain rated 5 or greater during the preceding week will be eligible for the study. We will enroll 66 participants with 33 patients in each arm. | Drug: Tibetree Pain Relieving Plaster<br>* Participants who provide informed consent in the trial will receive either the Tibetree pain relieving plaster if randomized into the intervention arm, or an identical placebo plaster if randomized into the control arm. The treatment course for both arms are identical. Participants will be instructed to apply the plaster directly to the skin overlying the area of pain for 6 hours once daily for 14 consecutive days.<br>* Other names: Tibetree RP;|
| Placebo Comparator: Placebo plaster groups<br>Participants with chronic musculoskeletal pain for ≥ 3 months and with BPI worst pain rated 5 or greater during the preceding week will be eligible for the study. We will enroll 66 participants with 33 patients in each arm. | Other: Placebo<br>* Participants who provide informed consent in the trial will receive either the Tibetree pain relieving plaster if randomized into the intervention arm, or an identical placebo plaster if randomized into the control arm. The treatment course for both arms are identical. Participants will be instructed to apply the plaster directly to the skin overlying the area of pain for 6 hours once daily for 14 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory - Measure of Participant Pain | The short-form BPI will be used to quantify pain severity and pain interference. The BPI contains 4 pain severity items and 7 pain interference items, all rated on a scale from 0 to 10 (higher ratings indicate worse pain intensity/interference). A pain severity subscale score can be computed by taking the average rating of the 4 pain severity items. This subscale will be our primary outcome measure. A pain interference subscale score can be similarly computed for the 7 pain interference items. BPI should be completed prior to removing pain relieving plaster at the end of each day. | 14 days from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tibetree, Tibetree Pain-Relieving, Cancer, Pain, Cancer survivor, 20-496, Memorial Sloan Kettering Cancer Center