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Recruiting NCT07447856

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

Phase I Interventional Cancer Patients Survivor Patients Cancer Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Topical herbal plaster.
Who it may be relevant to
Registry conditions: Cancer Patients, Survivor Patients, Cancer Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Enrollment rate [Time frame: 2 years]
  • Treatment adherence rate [Time frame: 2 years]
  • Assessment completion rates [Time frame: 2 years]
  • Treatment satisfaction [Time frame: day 7]
Secondary outcome measures (1)
  • pain severity [Time frame: up to day 7]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre

Identifiers

NCT: NCT07447856 · 25-376

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗