A Study Testing Topical Pain-Relieving Herbal Plasters in People Who Are Using Opioids for Their Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Topical herbal plaster
DrugParticipants will receive topical herbal plaster once a day for up to 8 hours daily for 7 days.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Topical herbal plasterExperimental treatment 1 intervention
Group B: Waitlist control group (WLC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Enrollment rate
This is the proportion of patients who enroll in the study among those who are eligible and offered participation.
Time frame
2 years2
Treatment adherence rate
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.
Time frame
2 years3
Assessment completion rates
The proportion of randomized patients who complete the patient-reported assessments.
Time frame
2 years4
Treatment satisfaction
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
Time frame
day 7Secondary outcomes
1
pain severity
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)
Time frame
up to day 7Sponsors and contacts
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Source ClinicalTrials.gov