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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Enrollment rate [Срок оценки: 2 years]
• Treatment adherence rate [Срок оценки: 2 years]
• Assessment completion rates [Срок оценки: 2 years]
• Treatment satisfaction [Срок оценки: day 7]

Вторичные конечные точки (1)

• pain severity [Срок оценки: up to day 7]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• 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

Идентификаторы

NCT: NCT07447856 · 25-376

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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