Skin ToxicityNCT04650256
Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
A study testing Complementary and alternative medicine (CAM) in people with Skin Toxicity, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Skin Toxicity
- What is being tested?
- Complementary and alternative medicine (CAM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects with newly diagnosed breast carcinoma
- > 18 years of age
- Post-mastectomy with or without reconstruction
- Stage II-IIIb with any receptor status
- All races and ethnicities are eligible
- Patients must be able to consent in English or Spanish
Show all 11Show fewer
- Plan to receive adjuvant radiotherapy to the chest wall +/- regional lymph nodes
- RT will involve standard fractionation use of 3D conformal or Intensity-modulated RT (IMRT)
- Willing to sign protocol consent form
- Patients are allowed to receive adjuvant hormonal therapy and/or targeted therapies such as trastuzumab prior to, during and/or after radiation therapy.
- Patients may receive chemotherapy before or after radiation therapy
Who cannot join
- Prior radiation to the involved breast or chest wall
- Concurrent chemotherapy
- Unable or unwilling to sign informed consent
- Unable to speak English or Spanish
- Pregnant women
- Clinical or pathologic stage T4
- Metastatic disease
- Connective tissue disorder including Systemic Lupus Erythematosus and Scleroderma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Jennifer J Hu, PhD, 305-243-7796, jhu@med.miami.edu
Jennifer J Hu, PhD
About this study
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.
- Conditions
- Skin Toxicity
- Being tested
- Complementary and alternative medicine (CAM)
- Keywords
- Breast cancer, Radiotherapy, Complementary and alternative medicine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary and alternative medicine (CAM)Other
CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.
| Study group | Role | What they receive |
|---|---|---|
| CAM arm | Experimental | 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. Receives: Other: Complementary and alternative medicine (CAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients free of clinically relevant skin toxicities
Clinically relevant skin toxicities - Grade 2 with moist desquamation or Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) as evaluated by the treating clinician.
Measured: Up to 18 weeks.
Secondary outcomes (3)
SD-16 scores
Skindex 16 (SD-16) will be used to assess patients' self-assessment of skin effects. SD-16 has a total score ranging from 0-96 with a higher score indicating greater skin effects.
Measured: Up to 18 weeks.
Functional Assessment of Cancer Therapy-Breast (FACT-B) scores
FACT-B in breast cancer patients will be used to obtain patient's self-assessment of health-related quality of life. FACT-B has a total score ranging from 0-148 with a higher score indicating a better quality of life.
Measured: Up to 18 weeks.
High-sensitivity C-reactive protein (hsCRP) values
The inflammatory biomarker, plasma high-sensitivity C-reactive protein (hsCRP) will be evaluated using blood samples.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Jul 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ToxicityStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- VAUGHN-JORDAN FOUNDATION, INC., Florida Breast Cancer Foundation
- Responsible party
- Principal investigator, Jennifer Hu, University of Miami
- Investigators
- Jennifer J Hu, PhD, Principal investigator, U. of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650256
- Sponsor's protocol ID
- 20200491
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
- ClinicalTrials.gov ID
- NCT04650256
- Acronym / sponsor ID
- 20200491
- Conditions
- Skin Toxicity
- Keywords
- Breast cancer, Radiotherapy, Complementary and alternative medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- VAUGHN-JORDAN FOUNDATION, INC., Florida Breast Cancer Foundation
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAM arm | Experimental | Other: Complementary and alternative medicine (CAM)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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female subjects with newly diagnosed breast carcinoma
- > 18 years of age
- Post-mastectomy with or without reconstruction
- Stage II-IIIb with any receptor status
- All races and ethnicities are eligible
Key exclusion criteria (8 listed)
- Prior radiation to the involved breast or chest wall
- Concurrent chemotherapy
- Unable or unwilling to sign informed consent
- Unable to speak English or Spanish
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complementary and alternative medicine (CAM)CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily. | Other | CAM arm |
Primary outcome
Proportion of patients free of clinically relevant skin toxicities
Time frame: Up to 18 weeks.
Clinically relevant skin toxicities - Grade 2 with moist desquamation or Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) as evaluated by the treating clinician.
3 secondary outcomes
SD-16 scores
Time frame: Up to 18 weeks.
Functional Assessment of Cancer Therapy-Breast (FACT-B) scores
Time frame: Up to 18 weeks.
High-sensitivity C-reactive protein (hsCRP) values
Time frame: Up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer J Hu, PhD principal investigator
U. of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complementary and alternative medicine (CAM) in people with Skin Toxicity, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer J Hu, PhD (3052437796, jhu@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients free of clinically relevant skin toxicities (time frame: Up to 18 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.