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NCT Number: NCT07447856

A Study Testing Topical Pain-Relieving Herbal Plasters in People Who Are Using Opioids for Their Pain

The are doing this study to find out whether using topical (on the skin) herbal plasters, Tibetree pain- relieving plasters (PRPs), can be an effective addition to standard opioid therapy for pain management. The researchers will look at whether the Tibetree PRPs are a practical (feasible) and effective way of managing localized pain (pain that is limited to a certain area) in people who are currently taking opioids. Participants in this study will have cancer or have had it in the past.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical herbal plaster

Drug

Participants will receive topical herbal plaster once a day for up to 8 hours daily for 7 days.

Primary outcomes

  1. Enrollment rate

    Time frame: 2 years

    This is the proportion of patients who enroll in the study among those who are eligible and offered participation.

  2. Treatment adherence rate

    Time frame: 2 years

    The treatment adherence rate is defined as the proportion of patients who are in the intervention period (both arms) who complete at least 5 of the 7 days of herbal plaster application.

  3. Assessment completion rates

    Time frame: 2 years

    The proportion of randomized patients who complete the patient-reported assessments.

  4. Treatment satisfaction

    Time frame: day 7

    will be measured on Day 7 of the intervention period. Satisfaction will be measured using two questions with five-point Likert-type response scales to assess overall satisfaction with integrating the patch into their opioid pain management plan and their willingness to recommend it to other patients. Patients will be considered "satisfied" with the treatment if they respond as "Satisfied" or "Very satisfied" to the satisfaction item

Secondary outcomes

  1. pain severity

    Time frame: up to day 7

    The Brief Pain Inventory (BPI) will be used to quantify pain severity. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Mao, MD, MSCE

CONTACT

[email protected]

646-888-0863

Kevin Liou, MD

CONTACT

646-608-8563

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Integrating Topical Herbal Plasters to Enhance Pain Management and Reduce Opioid Use in Cancer Patients (EASE)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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