Chinese Herbal Medicine for Skin Toxicities

Overseen By Jennifer J Hu, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Prior radiation, Concurrent chemotherapy, Metastatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a Chinese herbal product to ease pain and itching experienced by some women after radiotherapy for breast cancer. The product contains 1% menthol, known for its cooling and soothing effects. Women newly diagnosed with stage II-IIIb breast cancer and planning to receive radiotherapy might be suitable candidates for this study. Participants will use the herbal product during and after their radiotherapy sessions to determine if it relieves skin discomfort. As an unphased trial, this study offers participants the chance to explore a potentially soothing treatment option for radiotherapy-related skin discomfort.

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 prior data suggests that this Chinese herbal CAM product is safe for temporary relief of pain and itching after radiotherapy?

Research has shown that Chinese herbal remedies, like the one in this trial, can sometimes cause allergic reactions. One study found allergic reactions to be the most common issue, affecting 11 out of 27 participants. Other issues included dizziness and stomach problems. Additionally, these herbal products can increase skin sensitivity to sunlight, potentially leading to skin problems.

This product, available over the counter and containing menthol, is generally considered safe for many people. However, monitoring for any unusual reactions remains advisable if one decides to try it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Chinese Herbal CAM product for treating skin toxicities because it offers a natural, alternative approach that might have fewer side effects than conventional treatments like corticosteroids and moisturizers. Unlike these standard treatments, which primarily address symptoms, the herbal formulation could potentially enhance skin repair and resilience during and after radiotherapy. The unique blend of herbs in this CAM product might also provide anti-inflammatory and healing benefits, targeting the root causes of skin damage rather than just offering temporary relief.

What evidence suggests that this Chinese herbal CAM product is effective for skin toxicities?

Research has shown that Chinese herbal medicine can help delay skin problems caused by radiation therapy. One study found it could postpone radiation-related skin issues by four days compared to usual treatments. Traditional Chinese medicine has also been found to help with skin conditions like atopic dermatitis, a type of skin inflammation. In this trial, participants will receive a Chinese Herbal CAM Product during and after their standard radiotherapy. Although evidence for some specific herbal treatments may be limited, these findings suggest that the herbal product might help relieve skin pain and itching after radiotherapy. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer J Hu, PhD

Principal Investigator

U. of Miami

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I cannot speak English or Spanish.

My cancer is at stage T4.

You are pregnant.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Chinese Herbal CAM Product

Trial Overview The 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.

How Is the Trial Designed?

Group I: CAM arm Experimental Treatment 1 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.

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+

Published Research Related to This Trial

Chinese herbal medicines (CHM) and Chinese proprietary medicines (CPM) are generally safe but can cause severe poisoning in rare cases due to toxic components like aconitine and podophyllin.

There is a risk of contamination in CHM and CPM with substituted herbs and heavy metals, which can lead to serious health issues, highlighting the need for better regulation and awareness among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chinese herbal medicines revisited: a Hong Kong perspective. Chan, TY., Chan, JC., Tomlinson, B., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The study identified 74 potentially toxic Chinese herbal medicines and proposed a regulatory framework categorizing them into four classes based on their toxicity and safety profiles, including 'Prohibited' and 'Restricted' categories for the most dangerous herbs.

The research emphasizes the need for updated regulations in both China and Australia to ensure safe use of these herbs, suggesting that access to highly toxic herbs should be limited to qualified practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based toxicity evaluation and scheduling of Chinese herbal medicines. Kim, EJ., Chen, Y., Huang, JQ., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and safety of Chinese herbal medicines guided by a systems biology perspective. Wang, J., van der Heijden, R., Spruit, S., et al.[2009]

In a study of 10 patients experiencing skin toxicity from EGFR inhibitors, treatment with Chinese herbal medicine (CHM) led to a significant improvement in quality of life, as indicated by a drop in Skindex-16 scores from 74.5% to 19.3% after an average of 3.4 weeks of treatment (p < 0.001).

CHM also resulted in an 82% reduction in the distribution of skin lesions, demonstrating its efficacy and safety for managing mild to moderate dermatologic events related to EGFR inhibitors, although further well-designed studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.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. Hung, YC., Chin, CY., Lee, YC., et al.[2020]

In a study of 1701 patients admitted to a hospital in Hong Kong, only 0.2% of admissions were linked to adverse reactions from Chinese herbal medicines (CHM), indicating a low incidence of serious side effects.

However, two of the three cases were life-threatening, highlighting the need for ongoing monitoring and research into the safety of CHM, especially in communities where they are widely used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital admissions due to adverse reactions to Chinese herbal medicines. Chan, TY., Chan, AY., Critchley, JA.[2004]

Traditional Chinese medicine (TCM) has safety concerns, particularly regarding the toxicity of certain Chinese materia medica (CMM), but overall, it appears to have fewer adverse reactions compared to conventional drugs.

Adulteration of herbal products with pharmaceuticals poses significant risks, and some herbs, like Aconitum and Aristolochia species, have narrow therapeutic ranges that can lead to toxic effects, highlighting the need for better monitoring and safety information in TCM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicological risks of Chinese herbs. Shaw, D.[2022]

In a study involving 110 patients with dermatologic toxicities from targeted anticancer therapies, topical application of Compound Danxiong Granules (CDG) significantly reduced skin toxicity, achieving a total effective rate of 77.61% compared to 27.27% in the placebo group.

CDG was particularly effective for specific skin reactions, such as hand-foot skin reaction (95.45% effective) and acneiform eruptions (69.23% effective), demonstrating its potential as a beneficial treatment to improve patient comfort during cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Topical Compound Danxiong Granules for Treatment of Dermatologic Toxicities Induced by Targeted Anticancer Therapy: A Randomized, Double-Blind, Placebo-Controlled Trial. Tian, A., Zhou, A., Bi, X., et al.[2020]

A new adverse events (AEs) reporting form specifically designed for Korean folk medicine has been developed, incorporating unique characteristics such as folk medicine properties and patient information.

This reporting form is the first of its kind and aims to improve the tracking and understanding of adverse events related to Korean folk medicine, enhancing safety and efficacy monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an adverse events reporting form for Korean folk medicine. Park, JH., Choi, SM., Moon, S., et al.[2021]

The safe use of Chinese materia medica (CMM) in traditional Chinese medicine (TCM) relies on proper identification, good manufacturing practices, and rational combinations, but these may not guarantee safety without thorough toxicological investigations.

Integrating biomedical science with TCM principles can help detect early adverse drug reactions (ADRs) and improve the quality control of CMM, potentially reducing the incidence of ADRs when using TCM products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview on adverse drug reactions to traditional Chinese medicines. Chan, K., Zhang, H., Lin, ZX.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257048/

Prevention of Radiodermatitis With Topical Chinese Herbal ... One study showed that TCHM could delay the occurrence of radiation dermatitis for 4 days compared to conventional therapy. Another study showed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11896621/

The Efficacy of Complementary and Alternative Medicines ... Traditional Chinese herbal medicine (TCM), typically an extract of 10 herbs, was reported effective for atopic dermatitis (AD) in early 1990s RCTs. In RCTs from ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2452109418302239

International Survey on the Use of Complementary and ... In our study, the most commonly reported CAM remedies were aloe vera products (n = 45) for skin toxicity, exercise (n = 14) for fatigue, ginger (n = 11) for ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2017/6026434

The Traditional Chinese Medicine and Relevant Treatment ... Results. The results revealed that traditional Chinese medicines and related treatments did not show statistical differences in clinical ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04888234

Evaluation the Effectiveness of Ru-Yi-Jin-Huang Powder ... Ru-Yi-Jin-Huang Powder is one of most common topical TCM drug to treat skin diseases but lack of evidence to support efficacy. The aim of this ...

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Adverse effects of herbal drugs in dermatology Virtually all herbal remedies can cause allergic reactions and several can be responsible for photosensitization.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962217320649

Dermatoses caused by cultural practices: Therapeutic ... Therapeutic practices can cause a range of complications, including contact dermatitis, heavy metal toxicity, and severe cutaneous adverse reactions.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2014/609064

Irritant Contact Dermatitis Risk of Common Topical ... The herbal constituents of this topical Chinese medicinal formula are known to cause appreciable antityrosinase activity and suppress tyrosinase ...

9. bmccomplementmedtherapies.biomedcentral.com bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/1472-6882-13-336

Acute adverse events from over-the-counter Chinese herbal ... Of the 27 adverse events cases reported among COTC users, the most common were allergic reactions (n = 11) dizziness (n = 5), and gastro-intestinal problems (n ...

10. researchgate.net researchgate.net/publication/12257124_Adverse_effect_of_herbal_drugs_in_dermatology

Adverse effect of herbal drugs in dermatology | Request PDF Virtually all herbal remedies can cause allergic reactions and several can be responsible for photosensitization. Some herbal medicines, in ...