Recruiting
Evaluation of the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients
the purpose of this study is to evaluate the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients
ClinicalTrials.gov IDNCT07256119
PhaseNA
Enrollment40
SponsorAin Shams University
Age18 Years
SexFEMALE
Conditions studied
Prevention
About this study
the purpose of this study is to evaluate the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients
Interventions
- Dietary Supplement: Alpha Lipoic Acid — alpha lipoic acid 300 mg three times daily under the trade name of THIOTACID manufactured by EVAPHARMA.
Primary outcomes
- Incidence of development of radiation induced dermatitis (RID) (weekly after every fifth Radiotherapy session till the end of study (3 weeks).)
- Evaluation of the Severity of radiation-induced dermatitis (RID) developed (weekly after every fifth Radiotherapy session till the end of study (3 weeks).)
- Evaluation of Inflammatory biomarker level (Interleukin-6) (baseline, end of study Up to 3 Weeks)
- Evaluation of Incidence of Treatment-Emergent Adverse Events (weekly after every fifth Radiotherapy session till the end of study (3 weeks).)
Eligibility information
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.
Study locations
- Zagazig University Hospitals, Zagazig, Egypt
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.