Tibetree topical herbal plasters for people using opioids for cancer pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study adds a topical Tibetree herbal plaster to standard short-term oral opioid therapy in adults with current or past cancer who have localized pain that can be covered by a single patch. Eligible participants must have a worst pain score of 4 or greater in the past week and be ambulatory with a Karnofsky score ≥60. Participants will be randomized to one of two study arms and will apply the plaster to the painful area while researchers monitor feasibility, safety, and changes in pain scores. The study is conducted at Memorial Sloan Kettering locations in New Jersey and focuses on short-term, localized pain control as an adjunct to opioids.

Why it matters

Who can join: the full rules

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 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, 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.

Where it's running

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jun Mao, MD, MSCE — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jun Mao, MD, MSCE
• Email: maoj@mskcc.org
• Phone: 646-888-0863

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.