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Chinese Herbal Medicine for Skin Toxicities

N/A

Recruiting

Led By Jennifer J Hu, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage II-IIIb with any receptor status

Post-mastectomy with or without reconstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 weeks.

Awards & highlights

Study Summary

This trial will study whether the CAM product is effective in reducing pain and itching after RT.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of the CAM product might include local skin reactions such as additional redness or irritation at the site of application due to menthol content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is at stage II-IIIb, regardless of receptor status.

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I have had a mastectomy, with or without reconstruction.

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I am planning to undergo radiotherapy to my chest wall and possibly lymph nodes.

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I can give my consent in English or Spanish.

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I am a woman over 18 with newly diagnosed breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients free of clinically relevant skin toxicities

Secondary outcome measures

Functional Assessment of Cancer Therapy-Breast (FACT-B) scores

C-reactive protein

SD-16 scores

Trial Design

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Florida Breast Cancer FoundationUNKNOWN

2 Previous Clinical Trials

120 Total Patients Enrolled

University of MiamiLead Sponsor

902 Previous Clinical Trials

410,036 Total Patients Enrolled

VAUGHN-JORDAN FOUNDATION, INC.UNKNOWN

Media Library

Complementary and alternative medicine (CAM) Clinical Trial Eligibility Overview. Trial Name: NCT04650256 — N/A

Skin Toxicities Research Study Groups: CAM arm

Skin Toxicities Clinical Trial 2023: Complementary and alternative medicine (CAM) Highlights & Side Effects. Trial Name: NCT04650256 — N/A

Complementary and alternative medicine (CAM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04650256 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being enrolled in this research endeavor?

"Clinicaltrials.gov indicates that this ongoing clinical trial, which was initially created on July 1st 2021 and last updated October 19th 2022, is actively recruiting patients."

Answered by AI

What is the projected enrollment for this research endeavor?

"Affirmative, according to the information made available on clinicaltrials.gov, this research project is actively recruiting volunteers who meet its requirements. The trial was first posted on July 1st 2021 and has since been updated as recently as October 19th 2022. A total of 40 participants are needed from one clinical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences

Jennifer Hu 2021. "Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04650256.