Clinical trial · Interventional
Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
NCT04650256CI-TRIAL-00106630recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complementary and alternative medicine (CAM) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAM arm
- description
- 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.
- interventionNames
- Other: Complementary and alternative medicine (CAM)
Primary outcomes (1)
- measure
- Proportion of patients free of clinically relevant skin toxicities
- timeFrame
- Up to 18 weeks.
- description
- 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.
Secondary outcomes (3)
- measure
- SD-16 scores
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.