Effect of nano-curcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial

Phase 3

• Conditions: A radiation burn is damage to the skin or other biological tissue caused by exposure to radiation. The radiation types of greatest concern are thermal radiation, radio frequency energy, ultraviolet light and ionizing radiation.; Radiation induced skin reactions.; L58.0

• Registration Number: IRCT20200513047427N1
• Lead Sponsor: Kashan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

Breast cancer patients who will undergo radiotherapy.

Exclusion Criteria

Patients whose breast region have previously been irradiated.
Patients with bilateral breast cancer.
Patients receiving concurrent chemotherapy and radiotherapy
Patients taking anticoagulants such as warfarin (Coumadin) or heparin
Patients with skin conditions (such as bleeding, ulcers or incurable wounds) or sensitivity to formulations
Patients treated by anti-epidermal growth factor (EGRF)
Patients undergoing minor radiation to the breast area
Patients with special skin allergies
Patients with diagnosis of inflammatory breast cancer and reconstructive treatment

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin burn grade. Timepoint: Determination of skin reaction? at the beginning of the study (before the intervention), 7, 14, 21, 28 and 35 days after the start of nano-curcumin capsule consumption. Method of measurement: Determination of skin reaction (skin burn grade) according to the criteria of the Radiotherapy-Oncology group by a radiation oncologist.