Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:33 AM
Study NCT ID:
NCT07447856
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Testing Topical Pain-Relieving Herbal Plasters in People Who Are Using Opioids for Their Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072716', 'term': 'Cancer Pain'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single center, two-arm, randomized trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment rate', 'timeFrame': '2 years', 'description': 'This is the proportion of patients who enroll in the study among those who are eligible and offered participation.'}, {'measure': 'Treatment adherence rate', 'timeFrame': '2 years', 'description': '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.'}, {'measure': 'Assessment completion rates', 'timeFrame': '2 years', 'description': 'The proportion of randomized patients who complete the patient-reported assessments.'}, {'measure': 'Treatment satisfaction', 'timeFrame': 'day 7', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'pain severity', 'timeFrame': 'up to day 7', 'description': '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)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tibetree', 'Tibetree Pain-Relieving', 'Cancer', 'Pain', 'Cancer survivor', '25-376'], 'conditions': ['Cancer Patients', 'Survivor Patients', 'Cancer Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* English speaking with age ≥ 18 years or older\n* 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.\n* Ambulatory (Karnofsky Performance Status of ≥ 60)\n* 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\n* Worst pain score (measured by the 0-10 numeric pain rating scale) 4 or above in the preceding week\n* Current use of short-term oral opioids (i.e. oxycodone, morphine immediate release, or hydromorphone) for pain management.\n* Willingness to adhere to and understanding of all study-related procedures, including randomization to one of the two possible study arms\n* Able to understand informed consent and provide signed informed consent form\n\nExclusion Criteria:\n\n* Patients are unwilling to reduce opioid use if their pain reduces\n* Patients have generalized musculoskeletal pain such as fibromyalgia as primary source of pain\n* Patients with clinician confirmed significant skin disorders such as severe eczema, psoriasis, severe xerosis, chronic dermatitis, or adhesive allergy.\n* Patients with open wounds, infections, skin trauma at skin overlying area of pain\n* Patients with documented history of skin sensitivity to adhesive or allergic reaction to other patches or topical analgesics\n* Patients with documented skin allergic reaction to plants or herbs\n* Patients who are unwilling to hold their current localized topical pain treatment (such as lidocaine patch) for the most severe pain site.\n* 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).\n* Patients who are planned to undergo initiation or change of the above pain management strategies in the 2 weeks following enrollment.\n* Patients who undergo initiation or change in standard cancer treatments (surgery, radiation, chemotherapy, hormonal therapy, immunotherapy, or targeted therapy) 1 week prior to enrollment.\n* 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."}, 'identificationModule': {'nctId': 'NCT07447856', 'briefTitle': 'A Study Testing Topical Pain-Relieving Herbal Plasters in People Who Are Using Opioids for Their Pain', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Integrating Topical Herbal Plasters to Enhance Pain Management and Reduce Opioid Use in Cancer Patients (EASE)', 'orgStudyIdInfo': {'id': '25-376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical herbal plaster', 'description': 'Will use the Tibetree PRPs on Days 1-7 of the treatment period.', 'interventionNames': ['Drug: Topical herbal plaster']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist control group (WLC)', 'description': 'Will use the Tibetree PRPs on Days 8-14 of the treatment period after a 7-day waiting period', 'interventionNames': ['Drug: Topical herbal plaster']}], 'interventions': [{'name': 'Topical herbal plaster', 'type': 'DRUG', 'description': 'Participants will receive topical herbal plaster once a day for up to 8 hours daily for 7 days.', 'armGroupLabels': ['Topical herbal plaster', 'Waitlist control group (WLC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0863'}], 'facility': 'Memorial Sloan Kettering Basking Ridge (All Protocol Activities)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0863'}], 'facility': 'Memorial Sloan Kettering Monmouth (All Protocol Activities)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0863'}], 'facility': 'Memorial Sloan Kettering Bergen (All Protocol Activities)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0863'}], 'facility': 'Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0863'}], 'facility': 'Memorial Sloan Kettering Westchester (All Protocol Activities)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0863'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activities)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Rockville Centre', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'phone': '646-888-0863'}], 'facility': 'Memorial Sloan Kettering Nassau (All Protocol Activities)', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'centralContacts': [{'name': 'Jun Mao, MD, MSCE', 'role': 'CONTACT', 'email': 'maoj@mskcc.org', 'phone': '646-888-0863'}, {'name': 'Kevin Liou, MD', 'role': 'CONTACT', 'phone': '646-608-8563'}], 'overallOfficials': [{'name': 'Jun Mao, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}