Integrating Topical Herbal Plasters to Enhance Pain Management and Reduce Opioid Use in Cancer Patients (EASE)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Enrollment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Topical herbal plaster
Will use the Tibetree PRPs on Days 1-7 of the treatment period.
干预措施: Topical herbal plaster (Drug)
Waitlist control group (WLC)
Will use the Tibetree PRPs on Days 8-14 of the treatment period after a 7-day waiting period
干预措施: Topical herbal plaster (Drug)
结局指标
主要结局
Enrollment rate
时间窗: 2 years
This is the proportion of patients who enroll in the study among those who are eligible and offered participation.
Treatment adherence rate
时间窗: 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.
Assessment completion rates
时间窗: 2 years
The proportion of randomized patients who complete the patient-reported assessments.
Treatment satisfaction
时间窗: 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
次要结局
- pain severity(up to day 7)