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

NCT07256119 | Recruiting

• 1 other identifier: RHDIRB2020110301 REC # 283
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prevention

Keywords

Radiation Induced Dermatitis; RID; Alpha Lipoic Acid; Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Incidence of development of radiation induced dermatitis (RID)

  If the patient developed Radiation induced dermatitis or not.

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

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

  severity will be scored using the Radiation Therapy Oncology Group (RTOG) criteria based on the clinical presentation.

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

• Evaluation of Inflammatory biomarker level (Interleukin-6)

  Assessing Serum level of Interleukin-6 (IL6) using ELISA kits.

  baseline, end of study Up to 3 Weeks

• Evaluation of Incidence of Treatment-Emergent Adverse Events

  Patients will be educated and instructed to report any adverse events.

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

Study Arms (2)

alpha lipoic acid

EXPERIMENTAL

patients will receive alpha lipoic acid 300 mg three times daily under the trade name of THIOTACID manufactured by EVAPHARMA for prophylaxis of the radiation-induced dermatitis (RID) from day 1 of radiation therapy till the end of the study.

Dietary Supplement: Alpha Lipoic Acid

Control

NO INTERVENTION

patients will not receive any prophylactic intervention as there is no standard of care for prophylaxis to the radiation-induced dermatitis (RID).

Interventions

Alpha Lipoic Acid DIETARY_SUPPLEMENT

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

alpha lipoic acid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Egypt

RECRUITING

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Rana Mohamed Elsayed Kelany Abdelkader

  Faculty of Pharmacy, Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana Mohamed Elsayed Kelany Abdelkader

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: August 6, 2024
• Primary Completion: December 28, 2025
• Study Completion: December 28, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

EG (1)