Health TrialsbyHealthPanel

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

ConditionPrevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Prior exposure to radiotherapy.

Inflammatory or metastatic breast carcinoma.

Patients with connective tissue disorders.

Patients with skin inflammatory diseases (e.g. ectopic dermatitis).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alpha Lipoic Acid

    Dietary supplement

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: alpha lipoic acidExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of development of radiation induced dermatitis (RID)

If the patient developed Radiation induced dermatitis or not.

Time frame
weekly after every fifth Radiotherapy session till the end of study (3 weeks).
2

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.

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

Evaluation of Inflammatory biomarker level (Interleukin-6)

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

Time frame
baseline, end of study Up to 3 Weeks
4

Evaluation of Incidence of Treatment-Emergent Adverse Events

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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