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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT04650256
Status
Recruiting

Conditions

  • Skin Toxicity

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Jul 1, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: CAM arm
    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.

Primary Outcome Measure

Proportion of patients free of clinically relevant skin toxicities [ Time Frame: Up to 18 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Jennifer J Hu, PhD
305-243-7796
Jennifer J Hu, PhD (PRINCIPAL_INVESTIGATOR)

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