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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2026-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Remission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The study coordinators, patients, PI, co-investigators, biostatisticians will be blinded to which treatment group the patient was assigned to.

Study Groups

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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.

Group Type EXPERIMENTAL

Tibetree Pain Relieving Plaster

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Tibetree RP

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes