Recruiting

Chinese Herbal Medicine

Sponsor:

University of Miami

Code:

NCT04650256

Conditions

Skin Toxicity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Complementary and alternative medicine (CAM)

Study Details

Brief 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.

Conditions

Skin Toxicity

Study ID

NCT04650256

Start date

Jul 1, 2021

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jennifer J Hu, PhD

3052437796jhu@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Jennifer J Hu, PhD

305-243-7796jhu@med.miami.edu

Principal Investigator:

Jennifer J Hu, PhD

More Information

Sponsor

University of Miami

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Breast cancer
  • Radiotherapy
  • Complementary and alternative medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-27.