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临床试验/NCT07256119
NCT07256119招募中不适用

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月6日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Incidence of development of radiation induced dermatitis (RID)

研究概览

简要总结

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

详细描述

Cancer is one of the leading causes of mortality worldwide, and cancer treatment options include chemotherapy, radiotherapy, surgery, and hormone therapy. Radiation therapy is a treatment based on the use of high-energy waves or radioactive particles to damage tumor cells to attenuate their growth. This modality has been effectively used for cancer treatment in more than 100 years.

Radiation therapy (RT) is one of the standard protocols with a high success rate for the treatment of breast cancer to reduce the risk of recurrence and death. The goal of radiation therapy is to destroy tumor cells with minimal damage to normal tissue. However, normal cells may be damaged when exposed to radiation.

Radiation-induced dermatitis (RID) occurs in 95% of patients receiving radiation therapy during their treatment. The skin cells located in close vicinity to the tumor cells receive large amounts of radiation, causing several complications such as redness, dry and wet desquamation, and tissue necrosis.

The occurrence of these complications in patients leads to discomfort, limited daily activities, and even stops radiotherapy, which negatively affects the cancer treatment. Symptoms usually appear 10-14 days following the initiation of treatment and carry on for 2 to 4 weeks during radiation therapy. Previous studies evaluated the effect of various topical and oral formulations in radiation-induced dermatitis. However, until now, there is no standard measure for the prevention of radiation-induced dermatitis in patients with breast cancer.

The mechanisms associated with radiation-induced dermatitis include inflammatory response and oxidative stress (OS). Inflammatory response and oxidative stress interact and promote each other. After radiation-induced cell damage, cells die in various forms, especially mitotic death, leading to inflammation and chronic oxidative stress. Understanding the mechanisms of chronic oxidative damage and injury of affected cells, tissues, and organs after exposure to radiation therapy may contribute to the development of treatment and management strategies of the complications associated with radiation therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Incidence of development of radiation induced dermatitis (RID)

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

If the patient developed Radiation induced dermatitis or not.

Evaluation of Inflammatory biomarker level (Interleukin-6)

时间窗: baseline, end of study Up to 3 Weeks

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

Evaluation of Incidence of Treatment-Emergent Adverse Events

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

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

Incidence of development of radiation induced dermatitis (RID)

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

If the patient developed Radiation induced dermatitis or not.

Evaluation of Incidence of Treatment-Emergent Adverse Events

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

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

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

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

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

Evaluation of Inflammatory biomarker level (Interleukin-6)

时间窗: baseline, end of study Up to 3 Weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rana mohamed

Principal Investigator

Ain Shams University

研究点 (1)

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