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Topical Herbal Plaster (Tibetree Pain-Relieving Plasters) to Enhance Pain Management and Reduce Opioid Use in Cancer Patients, EASE Trial
Trial Status: active
This clinical trial tests the effect of a herbal pain relieving plaster, Tibetree pain-relieving plaster (PRP), on the skin (topical) in combination with standard opioid therapy on pain management and opioid use in cancer patients. Opioids, such as morphine and codeine, are the most effective drug treatment for moderate to severe cancer-related pain. Despite their effectiveness, up to a third of patients do not respond. This often leads to higher doses and increased risks, such as sedation, dizziness, nausea, vomiting, constipation and respiratory depression. Tibetree PRP is an over-the-counter (non-prescription) patch that includes camphor and a blend of traditional Tibetan herbs. The patch is placed on the surface of the skin where the pain is the worst. It reduces pain by reducing inflammation. Studies have shown that Tibetree PRP can reduce pain in people who have long-lasting pain, but is not yet known if it will be as effective in those who are currently experiencing pain while taking opioids. Giving topical Tibetree PRP in combination with standard opioid therapy may be a safe, tolerable and practical way to manage pain that is limited to a certain area (localized) and reduce the use of opioids in cancer patients.
Inclusion Criteria
English speaking with 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 Memorial Sloan Kettering (MSK) confirmed biopsy/diagnosis. Outside institution’s testing is sufficient
Ambulatory (Karnofsky performance status of ≥ 60)
Having one of three types of pain (e.g., musculoskeletal pain, bone metastasis pain, and visceral/abdominal pain) and the worst pain area can be covered by one patch of topical herbal plaster
Worst pain score (measured by the 0-10 numeric pain rating scale) 4 or above in the preceding week
Current use of short-term oral opioids (i.e. oxycodone, morphine immediate release, or hydromorphone) for pain management
Willingness to adhere to and understanding of all study-related procedures, including randomization to one of the two possible study arms
Able to understand informed consent and provide signed informed consent form
Exclusion Criteria
Patients are unwilling to reduce opioid use if their pain reduces
Patients have generalized musculoskeletal pain such as fibromyalgia as primary source of pain
Patients with clinician confirmed significant skin disorders such as severe eczema, psoriasis, severe xerosis, chronic dermatitis, or adhesive allergy
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 unwilling to hold their current localized topical pain treatment (such as lidocaine patch) for the most severe pain site
Patients who undergo initiation or change in pain management strategies within 1 week prior to enrollment, including oral analgesics (e.g., opioids, non-steroidal antiinflammatory drugs [NSAIDs]), medications that can significantly reduce pain (e.g., bisphosphonates, denosumab), or interventional procedures (e.g., nerve blocks, palliative radiation)
Patients who are planned to undergo initiation or change of the above pain management strategies in the 2 weeks following enrollment
Patients who undergo initiation or change in standard cancer treatments (surgery, radiation, chemotherapy, hormonal therapy, immunotherapy, or targeted therapy) 1 week prior to enrollment
Patients who are planned to undergo initiation or change of active cancer treatments (surgery, radiation, chemotherapy, hormonal therapy, immunotherapy, or targeted therapy) in the 2 weeks following enrollment
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07447856.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Jun J. Mao
Phone: 646-888-0863
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Jun J. Mao
Phone: 646-888-0863
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Jun J. Mao
Phone: 646-888-0863
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Jun J. Mao
Phone: 646-888-0863
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Jun J. Mao
Phone: 646-888-0863
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Jun J. Mao
Phone: 646-888-0863
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Jun J. Mao
Phone: 646-888-0863
PRIMARY OBJECTIVE:
I. To evaluate the feasibility and acceptability of integrating topical herbal plasters as an adjunct to opioid therapy for pain management in cancer patients who are currently taking opioids and experiencing specific types of localized pain (e.g., musculoskeletal pain, bone metastasis pain, and visceral abdominal pain).
SECONDARY OBJECTIVES:
I. To obtain preliminary data on the effects of integrating topical herbal plasters on reducing pain severity among cancer patients currently taking opioids and experiencing localized pain.
II. To obtain preliminary data on the effects of integrating topical herbal plasters on reducing opioid dosing among cancer patients currently taking opioids and experiencing localized pain.
III. To evaluate the effectiveness of integrating topical herbal plasters in reducing opioid toxicity and other pain-related outcomes (e.g., pain interference) among cancer patients experiencing pain.
IV. To evaluate the adverse events associated with topical herbal plaster (i.e. skin rash).
V. To explore whether placebo and nocebo expectation are associated with pain severity reduction or experience of adverse events.
OUTLINE: After a 7-day baseline period, patients are randomized to 1 of 2 groups.
GROUP I: Patients continue to take current standard of care opioid pain medications as prescribed and apply camphor/herbal formulation-based topical plaster (Tibetree PRP) topically for up to 8 hours once daily (QD) on days 1-7.
GROUP II: After a 7-day waitlist period, patients continue to take current standard of care opioid pain medications and apply Tibetree PRP topically for up to 8 hours QD on days 8-14.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
