40 Participants Needed

Chinese Herbal Medicine for Skin Toxicities

JJ
Overseen ByJennifer J Hu, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this research is to study a Chinese herbal Complementary and Alternative Medicine (CAM) product for the temporary relief of pain and itching after radiotherapy (RT). This is an over-the-counter product with 1% menthol as an active ingredient.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it allows for the use of adjuvant hormonal therapy and targeted therapies like trastuzumab, and chemotherapy can be given before or after radiation therapy.

What data supports the effectiveness of the Chinese Herbal CAM Product treatment for skin toxicities?

A study on Compound Danxiong Granules, a similar Chinese herbal treatment, showed it effectively reduced skin toxicities caused by cancer therapies, with a 77.61% success rate compared to 27.27% for a placebo. This suggests that Chinese herbal treatments can be effective for managing skin issues.12345

Is Chinese herbal medicine generally safe for humans?

Chinese herbal medicines are generally considered safe, but there have been reports of adverse reactions, often due to misuse or contamination. Proper processing and combining herbs can reduce toxicity, and only a small percentage of hospital admissions are due to these medicines.36789

How does the Chinese herbal treatment for skin toxicities differ from other treatments?

This Chinese herbal treatment is unique because it uses a combination of herbs applied topically to reduce skin toxicities, particularly those caused by cancer therapies. Unlike conventional treatments, it focuses on a multi-herb approach to target multiple pathways in the body, potentially reducing side effects and improving safety.2341011

Research Team

JJ

Jennifer J Hu, PhD

Principal Investigator

U. of Miami

Eligibility Criteria

This trial is for women over 18 with newly diagnosed breast carcinoma stages II-IIIb, planning to receive standard radiotherapy post-mastectomy. Participants can consent in English or Spanish and may have had chemotherapy before or after radiation but not concurrently. Pregnant women, those who've had prior chest radiation, metastatic disease, certain connective tissue disorders, or cannot consent are excluded.

Inclusion Criteria

My cancer is at stage II-IIIb, regardless of receptor status.
My radiation therapy will use advanced targeting techniques.
Willing to sign protocol consent form
See 7 more

Exclusion Criteria

I cannot speak English or Spanish.
My cancer is at stage T4.
You are pregnant.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive standard of care radiotherapy while using the CAM product for temporary relief of pain and itching

Up to 6 weeks

Post-radiotherapy Treatment

Participants continue using the CAM product for 8-12 weeks after radiotherapy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Chinese Herbal CAM Product
Trial OverviewThe study tests a Chinese herbal Complementary and Alternative Medicine (CAM) product containing 1% menthol for relieving pain and itching following radiotherapy. It's an over-the-counter remedy being evaluated for its effectiveness in improving skin toxicities associated with cancer treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CAM armExperimental Treatment1 Intervention
Participants will be given the CAM intervention during scheduled, standard of care radiotherapy (up to 6 weeks) and 8-12 weeks (weeks 14-18) after radiotherapy.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Florida Breast Cancer Foundation

Collaborator

Trials
3
Recruited
190+

Florida Breast Cancer Foundation

Collaborator

Trials
4
Recruited
310+

VAUGHN-JORDAN FOUNDATION, INC.

Collaborator

Trials
1
Recruited
40+

Findings from Research

The study utilized systems biology to investigate how specific Chinese herbal components can reduce toxicity in toxic herbs, focusing on protein expression and metabolite profiles in animal models.
Key molecules and pathways involved in toxicity control were identified and validated through molecular biology methods, providing insights into the mechanisms by which compatible Chinese herbs can mitigate toxicity in specific syndromes.
[Being Exposed to Specific Syndromes of Chinese Medicine and Being Compatible with Components of Chinese Herbs Are Important Ways to Control Toxicity of Toxic Chinese Herbs].Tan, Y., Li, J., Xiao, C., et al.[2019]
Out of 318 inquiries about Chinese traditional medicines, 273 were classified as poisonings, resulting in a mortality rate of 6.9%, primarily due to suicide attempts, accidents, or improper use.
Nearly half (47%) of the potential toxic effects of these medicines were unknown, highlighting the need for better identification of active ingredients, proper processing methods, and the development of safety protocols to prevent poisonings.
The difficulty in handling poisonings associated with Chinese traditional medicine: a poison control center experience for 1991-1993.Deng, JF., Lin, TJ., Kao, WF., et al.[2015]
Chinese herbal medicines (CMM) can be toxic, but proper processing and combining herbs can significantly reduce these toxic effects, as demonstrated with Aconitum roots.
The review emphasizes a systems approach in CMM, where multi-herb formulations are used to enhance safety and efficacy, suggesting that systems toxicology could be a valuable method for ensuring the quality of these herbal treatments.
Quality and safety of Chinese herbal medicines guided by a systems biology perspective.Wang, J., van der Heijden, R., Spruit, S., et al.[2009]

References

[Being Exposed to Specific Syndromes of Chinese Medicine and Being Compatible with Components of Chinese Herbs Are Important Ways to Control Toxicity of Toxic Chinese Herbs]. [2019]
The difficulty in handling poisonings associated with Chinese traditional medicine: a poison control center experience for 1991-1993. [2015]
Quality and safety of Chinese herbal medicines guided by a systems biology perspective. [2009]
Efficacy of Topical Compound Danxiong Granules for Treatment of Dermatologic Toxicities Induced by Targeted Anticancer Therapy: A Randomized, Double-Blind, Placebo-Controlled Trial. [2020]
Evidence-based toxicity evaluation and scheduling of Chinese herbal medicines. [2022]
Hospital admissions due to adverse reactions to Chinese herbal medicines. [2004]
Development of an adverse events reporting form for Korean folk medicine. [2021]
Toxicological risks of Chinese herbs. [2022]
An overview on adverse drug reactions to traditional Chinese medicines. [2018]
Chinese herbal medicines revisited: a Hong Kong perspective. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Clinical experience of chinese herbal medicine ameliorates dermatologic events from epidermal growth factor receptor inhibitors for lung cancer: A case series. [2020]