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 range

18 Years – 75 Years

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 75 Years

Sex

FEMALE

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).