Testing an Herbal Pain Relief Patch to Reduce Pain in Cancer Survivors

June 29, 2023 updated by: Memorial Sloan Kettering Cancer Center

Tibetree Pain-Relieving Plaster for Musculoskeletal Pain Among Cancer Survivors

The purpose of this study is to find out whether Tibetree Pain Relieving Plaster, an herbal pain relief patch, may be able to reduce this pain. Tibetree Pain Relieving Plaster is available as an over-the-counter (non-prescription) treatment for the temporary relief of minor aches and pains in muscles and joints. This study is the first to test this treatment in people who have had cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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. Participating institution's testing is sufficient for other study sites
  • Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment or maintenance targeted therapies will not be excluded).
  • Patients currently have no evidence of disease
  • Ambulatory (Karnofsky functional score of ≥ 60)
  • Having a focused location of regional musculoskeletal pain (e.g. joints, extremities, back, neck) that can be covered by one patch of PRP
  • Worst pain score (numeric pain rating scale) 5 or above in the preceding week
  • Pain for at least 3 months and at least 15 days with pain in the preceding 30 days; and willingness to adhere to and understanding of all study-related procedures, including randomization to one of the two possible choices
  • Able to understand informed consent and provide signed informed consent form

Exclusion Criteria:

  • Patients with non-musculoskeletal pain syndromes (headache, facial pain, chest pain, visceral abdominal pain) will be excluded if these are the sole source of pain but can be present as co-morbid conditions as long as a patient has a primary musculoskeletal pain condition defined as above.
  • Patients have generalized musculoskeletal pain such as fibromyalgia
  • Use of corticosteroid drugs by any route of administration within 30 days
  • Patients with significant self-reported skin disorders
  • 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 in active treatment (chemotherapy, surgery, radiotherapy)
  • Plan to change or initiate other pain medications or interventions (e.g. physical therapy, acupuncture, injection). Patients may remain on their current pain regimen.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tibetree pain relieving plaster
Participants with chronic musculoskeletal pain for ≥ 3 months and with BPI worst pain rated 5 or greater during the preceding week will be eligible for the study. We will enroll 66 participants with 33 patients in each arm.
Drug: Tibetree Pain Relieving Plaster
Participants who provide informed consent in the trial will receive either the Tibetree pain relieving plaster if randomized into the intervention arm, or an identical placebo plaster if randomized into the control arm. The treatment course for both arms are identical. Participants will be instructed to apply the plaster directly to the skin overlying the area of pain for 6 hours once daily for 14 consecutive days.
Other Names:
  • Tibetree RP
Placebo Comparator: Placebo plaster groups
Participants with chronic musculoskeletal pain for ≥ 3 months and with BPI worst pain rated 5 or greater during the preceding week will be eligible for the study. We will enroll 66 participants with 33 patients in each arm.
Other: Placebo
Participants who provide informed consent in the trial will receive either the Tibetree pain relieving plaster if randomized into the intervention arm, or an identical placebo plaster if randomized into the control arm. The treatment course for both arms are identical. Participants will be instructed to apply the plaster directly to the skin overlying the area of pain for 6 hours once daily for 14 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory - Measure of Participant Pain
Time Frame: 14 days from baseline
The short-form BPI will be used to quantify pain severity and pain interference. 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). A pain severity subscale score can be computed by taking the average rating of the 4 pain severity items. This subscale will be our primary outcome measure. A pain interference subscale score can be similarly computed for the 7 pain interference items. BPI should be completed prior to removing pain relieving plaster at the end of each day.
14 days from baseline

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • 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.

General Publications

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)

May 28, 2021

Primary Completion (Estimated)

May 28, 2024

Study Completion (Estimated)

May 28, 2024

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20-496

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

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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