Clinical trial NCT04916249: Testing an Herbal Pain Relief Patch to Reduce Pain in Cancer Survivors
Official title: Tibetree Pain-Relieving Plaster for Musculoskeletal Pain Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cancer
Remission
Keywords: Tibetree
Tibetree Pain-Relieving
Cancer
Pain
Cancer survivor
20-496
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, two-arm, randomized, placebo-controlled trial comparing Tibetree PRP with a placebo control plaster.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brief Pain Inventory - Measure of Participant Pain
timeFrame: 14 days from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk - Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang M, Baser RE, Li SQ, Hou YN, Chong K, Zhang YL, Hoque I, Bao T, Mao JJ. Tibetan Herbal Pain-Relieving Plaster for Chronic Musculoskeletal Pain Among Cancer Survivors: Study Protocol of a Randomized, Double-Blind, Placebo-Controlled Trial. Front Pharmacol. 2022 May 4;13:878371. doi: 10.3389/fphar.2022.878371. eCollection 2022.