RecruitingNot Applicable

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

Egypt40 participantsStarted 2024-08-06

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of development of radiation induced dermatitis (RID)

Timeframe: weekly after every fifth Radiotherapy session till the end of study (3 weeks).

Evaluation of the Severity of radiation-induced dermatitis (RID) developed

Timeframe: weekly after every fifth Radiotherapy session till the end of study (3 weeks).

Evaluation of Inflammatory biomarker level (Interleukin-6)

Timeframe: baseline, end of study Up to 3 Weeks

Evaluation of Incidence of Treatment-Emergent Adverse Events

Timeframe: weekly after every fifth Radiotherapy session till the end of study (3 weeks).

Trial details

NCT IDNCT07256119

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-28

Contact for this trial

Rana Mohamed Elsayed Kelany Abdelkader

00201023262639 rana.mohamed18@pharma.asu.edu.eg

View on ClinicalTrials.gov More Prevention trials

Who can participate

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of development of radiation induced dermatitis (RID)

Timeframe: weekly after every fifth Radiotherapy session till the end of study (3 weeks).

Evaluation of the Severity of radiation-induced dermatitis (RID) developed

Timeframe: weekly after every fifth Radiotherapy session till the end of study (3 weeks).

Evaluation of Inflammatory biomarker level (Interleukin-6)

Timeframe: baseline, end of study Up to 3 Weeks

Evaluation of Incidence of Treatment-Emergent Adverse Events

Timeframe: weekly after every fifth Radiotherapy session till the end of study (3 weeks).