Herbal Pain Relief Patch for Cancer-related Pain

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

68 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment for cancer-related pain?

Research shows that Tibetan herbal pain-relieving plaster, similar to the Tibetree Pain Relieving Plaster, is being studied for its potential to relieve chronic musculoskeletal pain in cancer survivors. Additionally, Chinese herbal medicine has been reviewed for its effectiveness in treating cancer pain, suggesting that herbal treatments may offer some pain relief. ^{1 2 3 4 5}

Is the Herbal Pain Relief Patch safe for humans?

The Tibetan herbal pain-relieving plaster, also known as Tibetree Pain Relieving Plaster, is being studied for safety in cancer survivors with chronic musculoskeletal pain. The study will monitor any adverse events to provide initial evidence on its safety. ^{1 2 4 6 7}

How is the Tibetree Pain Relieving Plaster different from other treatments for cancer-related pain?

The Tibetree Pain Relieving Plaster is unique because it is a topical herbal treatment specifically designed for external use, which may offer pain relief with potentially fewer side effects compared to conventional oral medications. It is being studied for its effectiveness and safety in cancer survivors with chronic musculoskeletal pain, providing an alternative to traditional pain management options. ^{1 2 4 8 9}

Research Team

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Chinese herbal medicine for cancer pain. [2007]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Tibetan Herbal Pain-Relieving Plaster for Chronic Musculoskeletal Pain Among Cancer Survivors: Study Protocol of a Randomized, Double-Blind, Placebo-Controlled Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Herbal Topical Analgesic for Pain Management: Perspectives from Cancer Patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Ojeok-san ameliorates visceral and somatic nociception in a mouse model of colitis induced colorectal cancer. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Meta-analysis of oral Chinese herbal medicine as an adjuvant treatment in relieving pain secondary to bone metastases. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of CheeZheng Pain Relieving Plaster for Musculoskeletal Pain: Implications for Oncology Research and Practice. [2021]

7. China pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Tongkuaixiao ointment in reliving cancer-induced pain: a multicenter double-blind placebo-controlled randomized trial. [2019]

8. China pubmed.ncbi.nlm.nih.gov

Mechanisms of treatment of cancer pain with a topical Chinese herbal formula in rats. [2011]

9. China pubmed.ncbi.nlm.nih.gov

Alleviation of cancerous pain by external compress with Xiaozheng Zhitong Paste. [2021]