Herbal Pain Relief Patch for Cancer-related Pain

Not currently recruiting at 9 trial locations

Overseen By Jun Mao, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Corticosteroids

Disqualifiers: Fibromyalgia, Skin disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an herbal pain relief patch can reduce cancer-related pain. The patch, called Tibetree Pain Relieving Plaster, is available in stores for minor aches but has not been tested on individuals with a history of cancer. The trial will compare the effects of the actual patch with a placebo (a dummy patch without active ingredients). Individuals with a past cancer diagnosis, who have completed active treatment, and have experienced musculoskeletal pain (pain in muscles and joints) for at least three months might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not require you to stop your current pain medications. You can stay on your existing pain regimen, but you should not plan to change or start new pain treatments during the study.

Is there any evidence suggesting that Tibetree Pain Relieving Plaster is likely to be safe for humans?

Research has shown that the Tibetree Pain Relieving Plaster is being tested for safety and effectiveness in reducing pain, particularly for cancer survivors. This herbal patch is commonly used over-the-counter for minor muscle and joint pain. However, its safety for cancer-related pain remains under investigation.

As this study is in an early phase, the plaster has shown promise in earlier trials for other uses, but researchers are still assessing its safety for cancer-related pain. Prospective participants should be aware that specific data on the plaster's safety for cancer patients is not yet available. The trial aims to gather this crucial information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The Tibetree Pain Relieving Plaster is unique because it uses a herbal formulation specifically designed to alleviate cancer-related pain. Unlike standard pain management options like opioids and NSAIDs, which often come with significant side effects, this plaster offers a non-invasive and potentially safer alternative. Researchers are excited because it targets pain directly through the skin, potentially providing faster relief without the systemic side effects associated with oral medications. The use of natural ingredients in the plaster could also mean fewer adverse reactions, making it a promising option for those seeking more holistic pain management solutions.

What evidence suggests that Tibetree Pain Relieving Plaster might be an effective treatment for cancer-related pain?

Research has shown that Tibetree Pain Relieving Plaster, which participants in this trial may receive, might help reduce long-term muscle and joint pain. Early results suggest it can also ease pain for cancer survivors. Pain levels, measured with the Brief Pain Inventory, decreased promisingly from Days 2 to 7. Some studies have also found improvements in sleep problems and anxiety. While more research is needed, these early findings offer hope for those seeking pain relief. Participants in the placebo plaster group will receive a dummy treatment for comparison. ^{1 2 3 4 6}

Who Is on the Research Team?

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are cancer survivors in remission, experiencing musculoskeletal pain for at least 3 months. They must have completed active cancer treatment at least a month ago but can be on hormone or maintenance therapies. Participants need to have a focused area of pain that can be covered by the patch and not suffer from generalized pain conditions like fibromyalgia.

Inclusion Criteria

I have been diagnosed with cancer, regardless of the type or stage.

I have pain in one area of my muscles or joints that can be treated with a single patch.

I have had pain for over 3 months and am willing to follow the study's procedures.

Exclusion Criteria

I have widespread body pain, like in fibromyalgia.

I have a primary musculoskeletal pain condition, not just headaches or abdominal pain.

I am not planning to change my current pain management plan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tibetree Pain Relieving Plaster or placebo for pain relief

2 weeks

Daily application of plaster

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tibetree Pain Relieving Plaster

Trial Overview The study tests Tibetree Pain Relieving Plaster, an herbal patch designed for temporary relief of minor muscle and joint pains, against a placebo. This is its first test among people who've had cancer to see if it reduces their pain effectively.

How Is the Trial Designed?

Group I: Tibetree pain relieving plaster Experimental Treatment 1 Intervention

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 II: Placebo plaster groups Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35600872/

Tibetan Herbal Pain-Relieving Plaster for Chronic ... - PubMed This randomized, placebo-controlled trial will provide the initial evidence on the efficacy and safety of the pain-relieving plaster for pain relief among ...

2. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.878371/full

Tibetan Herbal Pain-Relieving Plaster for Chronic ... The primary outcome is pain severity measured by the Brief Pain Inventory on Days 2–7. Secondary outcomes include changes in insomnia, anxiety, ...

3. researchgate.net researchgate.net/publication/360358258_Tibetan_Herbal_Pain-Relieving_Plaster_for_Chronic_Musculoskeletal_Pain_Among_Cancer_Survivors_Study_Protocol_of_a_Randomized_Double-Blind_Placebo-Controlled_Trial

(PDF) Tibetan Herbal Pain-Relieving Plaster for Chronic ... The primary outcome is pain severity measured by the Brief Pain Inventory on Days 2–7. Secondary outcomes include changes in insomnia, anxiety, depression, ...

4. bohrium.com bohrium.com/paper-details/tibetan-herbal-pain-relieving-plaster-for-chronic-musculoskeletal-pain-among-cancer-survivors-study-protocol-of-a-randomized-double-blind-placebo-controlled-trial/817356333136216064-6781

Tibetan Herbal Pain-Relieving Plaster for Chronic ... The results of this study will contribute to understanding the efficacy and safety of PRP for temporary pain relief among cancer survivors with ...

5. mskcc.org mskcc.org/cancer-care/integrative-medicine/herbs/cheezheng-pain-relieving-plaster

CheeZheng pain-relieving plaster Preliminary data suggest benefits of PRP in reducing chronic musculoskeletal pain in cancer survivors. Larger trials are needed to ...

6. mskcc.org mskcc.org/sites/default/files/node/12588/documents/im_fall2021_100821.pdf

About Integrative Medicine In a study open to cancer survivors of all types, Dr. Mao and his research team are assessing an herbal patch, Tibetree. Pain Relieving Plaster, ...