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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04916249

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

9.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Remission	Drug: Tibetree Pain Relieving Plaster Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

Tibetree Pain-Relieving Plaster for Musculoskeletal Pain Among Cancer Survivors

Actual Study Start Date :

May 28, 2021

Anticipated Primary Completion Date :

May 28, 2023

Anticipated Study Completion Date :

May 28, 2023

Arms and Interventions

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.

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

Other: Placebo

Outcome Measures

Primary Outcome Measures

Brief Pain Inventory - Measure of Participant Pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center @ Suffolk - Commack	Commack	New York	United States	11725
5	Memoral Sloan Kettering Westchester	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau	Uniondale	New York	United States	11553