Alpha lipoic acid to prevent radiation skin reactions in women with breast cancer
Official title: Evaluation of the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients
Run by Ain Shams University · NCT07256119 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Zagazig) |
| Status | Recruiting |
| Started | August 6, 2024 |
| Main results expected | December 28, 2025 |
| Study ends | December 28, 2025 |
| Registry record updated | December 12, 2025 |
| Trial ID | NCT07256119 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pharmacist-guided PEP/PrEP Access Using PEPPI Software
This trial tests whether the PEPPI software helps pharmacists provide PEP/PrEP and helps patients access these HIV prevention options.
-
Feasibility of Online HIV Prevention Research for People Who Inject Drugs
This study tests whether online recruitment and at-home HIV testing can be done reliably by and for people who inject drugs.
-
Host-led harm reduction for men who have sex with men who engage in chemsex in Bangkok
This project will try a host-led harm reduction approach to reduce substance-related, sexual, mental health, and legal harms among men who have sex with men who engage in chemsex in Bangkok.
-
Transgender-tailored harm reduction and PrEP service for people who engage in chemsex in Bangkok
This project will try a comprehensive harm-reduction service tailored for transgender and non-binary adults in Bangkok who engage in chemsex or substance use to increase PrEP use, reduce HIV/STIs, and address mental health and socio-legal needs.
-
See if PrEP Choice helps young people start and stick with HIV prevention methods
This trial tests whether the PrEP Choice package helps 13-24 year-olds in the U.S. begin and continue using PrEP or DoxyPEP for HIV prevention.
-
Adding sexual-pleasure conversations to harm reduction services for MSM and transgender people who do chemsex in Thailand
This project will try using a 'Pleasuremeter' to guide sexual-pleasure conversations in harm reduction services for MSM and transgender people who engage in chemsex or substance use in Thailand to see if it improves sexual health, substance use, and related outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.