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Recruiting NCT04650256

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

No phase Interventional Skin Toxicity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Complementary and alternative medicine (CAM).
Who it may be relevant to
Registry conditions: Skin Toxicity. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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 measures

  • Proportion of patients free of clinically relevant skin toxicities [Time frame: Up to 18 weeks.]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT04650256 · 20200491

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗