Alpha lipoic acid to prevent radiation skin reactions in women with breast cancer
Evaluation of the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients
This trial will test whether taking alpha lipoic acid can prevent radiation-induced skin irritation in women receiving adjuvant radiotherapy for early-stage breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Zagazig) |
| Trial ID | NCT07256119 on ClinicalTrials.gov |
What this trial studies
This interventional study gives alpha lipoic acid to women undergoing a standard course of postoperative radiotherapy (total 40 Gy in 15 sessions) and tracks skin reactions during and after treatment. Participants are adult women with histologically confirmed early invasive breast cancer who have not had prior radiotherapy and meet the trial's exclusion criteria. Skin effects such as redness, peeling, and more severe dermatitis will be recorded over the course of treatment and follow-up. The study excludes patients with inflammatory or metastatic disease, connective tissue or active skin inflammatory disorders, known allergy to alpha lipoic acid, or concurrent use of certain anti-inflammatory or antioxidant medications.
Who should consider this trial
Good fit: Women aged 18 or older with histologically confirmed early-stage invasive breast cancer scheduled for adjuvant radiotherapy (40 Gy over 15 sessions), who have not had prior radiotherapy and who do not have excluded comorbidities or contraindicated medications, are ideal candidates.
Not a fit: Patients with prior radiotherapy, inflammatory or metastatic breast cancer, connective tissue disorders, active skin inflammatory diseases, known allergy to alpha lipoic acid, or those taking prohibited anti-inflammatory or antioxidant drugs are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, alpha lipoic acid could reduce the frequency and severity of radiation-induced dermatitis, improving comfort and reducing interruptions to radiotherapy.
How similar studies have performed: Various topical and oral agents have been tested for preventing radiation dermatitis with mixed results and no established standard, and alpha lipoic acid for this specific indication remains relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged ≥18 years. * Histologically confirmed invasive, early-stage breast carcinoma scheduled for adjuvant radiotherapy. * Receiving total radiation dose of 40 Gy for 15 sessions. Exclusion Criteria: * Prior exposure to radiotherapy. * Inflammatory or metastatic breast carcinoma. * Patients with connective tissue disorders. * Patients with skin inflammatory diseases (e.g. ectopic dermatitis). * Patients with known allergy or hypersensitivity to alpha lipoic acid. * Concomitant use of nonsteroidal anti-inflammatory drugs, corticosteroids, or antioxidant medications. * Patients who will fail to sign the written consent.
Where this trial is running
Zagazig
- Zagazig University Hospitals — Zagazig, Egypt (Recruiting)
Study contacts
- Principal investigator: Rana Mohamed Elsayed Kelany Abdelkader — Faculty of Pharmacy, Ain Shams University
- Study coordinator: Rana Mohamed Elsayed Kelany Abdelkader
- Email: rana.mohamed18@pharma.asu.edu.eg
- Phone: 00201023262639
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.