Clinical trial · Interventional
Evaluation of the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients
NCT07256119CI-TRIAL-00098874recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
the purpose of this study is to evaluate the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prevention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha Lipoic Acid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- alpha lipoic acid
- description
- 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.
- interventionNames
- Dietary Supplement: Alpha Lipoic Acid
- type
- NO_INTERVENTION
- label
- Control
- description
- patients will not receive any prophylactic intervention as there is no standard of care for prophylaxis to the radiation-induced dermatitis (RID).
Primary outcomes (4)
- measure
- Incidence of development of radiation induced dermatitis (RID)
- timeFrame
- weekly after every fifth Radiotherapy session till the end of study (3 weeks).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.