Cancer PatientsPhase 1NCT07447856
A Study Testing Topical Pain-Relieving Herbal Plasters in People Who Are Using Opioids for Their Pain
A Phase 1 study testing Topical herbal plaster in people with Cancer Patients and Survivor Patients, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients, Survivor Patients, Cancer Pain
- What is being tested?
- Topical herbal plaster
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesUnited States
- Study dates
- 23 Feb 2026to Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kevin Liou, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Jun Mao, MD, MSCE, 646-888-0863
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11553
Jun Mao, MD, MSCE, 646-888-0863
About this study
Official title: Integrating Topical Herbal Plasters to Enhance Pain Management and Reduce Opioid Use in Cancer Patients (EASE)
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.
- Conditions
- Cancer Patients, Survivor Patients, Cancer Pain
- Being tested
- Topical herbal plaster
- Keywords
- Tibetree, Tibetree Pain-Relieving, Cancer, Pain, Cancer survivor, 25-376
- Medical subject headings
- Cancer Pain, Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical herbal plasterDrug
Participants will receive topical herbal plaster once a day for up to 8 hours daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Topical herbal plaster | Experimental | Will use the Tibetree PRPs on Days 1-7 of the treatment period. Receives: Drug: Topical herbal plaster |
| Waitlist control group (WLC) | Active comparator | Will use the Tibetree PRPs on Days 8-14 of the treatment period after a 7-day waiting period Receives: Drug: Topical herbal plaster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
This is the proportion of patients who enroll in the study among those who are eligible and offered participation.
Measured: 2 years
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.
Measured: 2 years
Assessment completion rates
The proportion of randomized patients who complete the patient-reported assessments.
Measured: 2 years
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
Measured: day 7
Secondary 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)
Measured: up to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start23 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center, two-arm, randomized trial.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Mao, MD, MSCE, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447856
- Sponsor's protocol ID
- 25-376
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Topical Herbal Plasters to Enhance Pain Management and Reduce Opioid Use in Cancer Patients (EASE)
- ClinicalTrials.gov ID
- NCT07447856
- Acronym / sponsor ID
- 25-376
- Conditions
- Cancer Patients, Survivor Patients, Cancer Pain
- Keywords
- Tibetree, Tibetree Pain-Relieving, Cancer, Pain, Cancer survivor, 25-376
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single center, two-arm, randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Topical herbal plaster | Experimental | Drug: Topical herbal plasterWill use the Tibetree PRPs on Days 1-7 of the treatment period. |
| Waitlist control group (WLC) | Active comparator | Drug: Topical herbal plasterWill use the Tibetree PRPs on Days 8-14 of the treatment period after a 7-day waiting period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical herbal plasterParticipants will receive topical herbal plaster once a day for up to 8 hours daily for 7 days. | Drug | Topical herbal plaster, Waitlist control group (WLC) |
Primary outcome
Enrollment rate
Time frame: 2 years
This is the proportion of patients who enroll in the study among those who are eligible and offered participation.
Treatment adherence rate
Time frame: 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
Time frame: 2 years
The proportion of randomized patients who complete the patient-reported assessments.
Treatment satisfaction
Time frame: 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
1 secondary outcome
pain severity
Time frame: up to day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Liou, MD contact
Jun Mao, MD, MSCE principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topical herbal plaster in people with Cancer Patients and Survivor Patients, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Mao, MD, MSCE (646-888-0863, maoj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.