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

NCT04916249 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20-496
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Cancer; Remission

Keywords

Tibetree; Tibetree Pain-Relieving; Cancer; Pain; Cancer survivor; 20-496; Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory - Measure of Participant Pain

  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

Study Arms (2)

Tibetree pain relieving plaster

EXPERIMENTAL

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

Placebo plaster groups

PLACEBO COMPARATOR

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

Interventions

Tibetree Pain Relieving Plaster DRUG

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.

Also known as: Tibetree RP

Tibetree pain relieving plaster

Placebo OTHER

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.

Placebo plaster groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Publications (1)

• Yang M, Baser RE, Li SQ, Hou YN, Chong K, Zhang YL, Hoque I, Bao T, Mao JJ. Tibetan Herbal Pain-Relieving Plaster for Chronic Musculoskeletal Pain Among Cancer Survivors: Study Protocol of a Randomized, Double-Blind, Placebo-Controlled Trial. Front Pharmacol. 2022 May 4;13:878371. doi: 10.3389/fphar.2022.878371. eCollection 2022.

  PMID: 35600872 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Mao, MD, MSCE

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study coordinators, patients, PI, co-investigators, biostatisticians will be blinded to which treatment group the patient was assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, two-arm, randomized, placebo-controlled trial comparing Tibetree PRP with a placebo control plaster.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 7, 2021
• Study Start: May 28, 2021
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (7)