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

February 25, 2026 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jun Mao, MD, MSCE
  • Phone Number: 646-888-0863
  • Email: maoj@mskcc.org

Study Contact Backup

  • Name: Kevin Liou, MD
  • Phone Number: 646-608-8563

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
        • Contact:
          • Jun Mao, MD, MSCE
          • Phone Number: 646-888-0863
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All Protocol Activities)
        • Contact:
          • Jun Mao, MD, MSCE
          • Phone Number: 646-888-0863
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All Protocol Activities)
        • Contact:
          • Jun Mao, MD, MSCE
          • Phone Number: 646-888-0863
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
        • Contact:
          • Jun Mao, MD, MSCE
          • Phone Number: 646-888-0863
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
        • Contact:
          • Jun Mao, MD, MSCE
          • Phone Number: 646-888-0863
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Jun Mao, MD, MSCE
          • Phone Number: 646-888-0863
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All Protocol Activities)
        • Contact:
          • Jun Mao, MD, MSCE
          • Phone Number: 646-888-0863

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Topical herbal plaster
Will use the Tibetree PRPs on Days 1-7 of the treatment period.
Drug: Topical herbal plaster
Participants will receive topical herbal plaster once a day for up to 8 hours daily for 7 days.
Active Comparator: Waitlist control group (WLC)
Will use the Tibetree PRPs on Days 8-14 of the treatment period after a 7-day waiting period
Drug: Topical herbal plaster
Participants will receive topical herbal plaster once a day for up to 8 hours daily for 7 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years
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.
2 years
Assessment completion rates
Time Frame: 2 years
The proportion of randomized patients who complete the patient-reported assessments.
2 years
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
day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pain severity
Time Frame: 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)
up to day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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