Cancer Pain, Cancer Patients, Survivor Patients
Conditions
Keywords
Tibetree, Tibetree Pain-Relieving, Cancer, Pain, Cancer survivor, 25-376
Brief summary
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
DRUGTopical herbal plaster
Participants will receive topical herbal plaster once a day for up to 8 hours daily for 7 days.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single center, two-arm, randomized trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | 2 years | This is the proportion of patients who enroll in the study among those who are eligible and offered participation. |
| Treatment adherence rate | 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 | 2 years | The proportion of randomized patients who complete the patient-reported assessments. |
| Treatment satisfaction | 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
| Measure | Time frame | Description |
|---|---|---|
| pain severity | 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) |
Countries
United States
Contacts
CONTACTJun Mao, MD, MSCE
CONTACTKevin Liou, MD
PRINCIPAL_INVESTIGATORJun Mao, MD, MSCE
Memorial Sloan Kettering Cancer Center
Outcome results
None listed