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Clinical Trials in Egypt / NCT07256119
Recruiting Not applicable

Evaluation of the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients

NCT07256119 · tracked via the Priya Life Science Egypt tracker
Sponsor
Ain Shams University
Phase
Not applicable
Started
2024-08-06
Last updated
2025-12-12

Condition(s) studied

Prevention

Investigational drug(s) / intervention(s)

Alpha Lipoic Acid

Alpha Lipoic Acid: alpha lipoic acid 300 mg three times daily under the trade name of THIOTACID manufactured by EVAPHARMA.

Study summary

the purpose of this study is to evaluate the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of development of radiation induced dermatitis (RID) — weekly after every fifth Radiotherapy session till the end of study (3 weeks).
    If the patient developed Radiation induced dermatitis or not.
  • Evaluation of the Severity of radiation-induced dermatitis (RID) developed — weekly after every fifth Radiotherapy session till the end of study (3 weeks).
    severity will be scored using the Radiation Therapy Oncology Group (RTOG) criteria based on the clinical presentation.
  • Evaluation of Inflammatory biomarker level (Interleukin-6) — baseline, end of study Up to 3 Weeks
    Assessing Serum level of Interleukin-6 (IL6) using ELISA kits.
  • Evaluation of Incidence of Treatment-Emergent Adverse Events — weekly after every fifth Radiotherapy session till the end of study (3 weeks).
    Patients will be educated and instructed to report any adverse events.

Trial sites (1)

FacilityCityRegionStatus
Zagazig University Hospitals Zagazig Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07256119 on ClinicalTrials.gov ↗ ← All trials in Egypt