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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Remission; Cancer

Treatments: Drug: Tibetree Pain Relieving Plaster; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04916249

20-496

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

Tibetree pain relieving plaster

Experimental group

Description:

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.

Treatment:

Drug: Tibetree Pain Relieving Plaster

Placebo plaster groups

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo