A Single Blinded Randomized Controlled Trial of the Comparative Effects of Tamoxifen and Evening Primrose Oil in Premenopausal Non-high Risk Patients With Benign Breast Disease With Respect to the Estrogen Receptor Status.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)
研究概览
简要总结
The purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respect to etiology and estrogen receptor status and to realize its side-effects and cost of therapy.
To do a comparative analysis of the results with evening primrose oil which is one of the first line management in benign breast disease.
详细描述
Benign breast disease is frequently encountered in female patients, a significant proportion of who are premenopausal women. Established methods of treatment do not yield significant results. This is not only a social burden but also entails high economic cost. As such the quality of life of these patients is a matter of concern for both the patients and their families and to attending physicians. Reported effects of tamoxifen on benign breast disease in premenopausal non high risk patients are scarce. Moreover published data has not yet revealed association of estrogen receptors in different benign breast lesions.The variability of response and its relation with estrogen receptor status is still a field of active investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical, Radiographic and Histological diagnosis of Benign Breast Disease.
- •Benign Breast disease amenable to hormonal therapy.
排除标准
- •Postmenopausal women.
- •Premenopausal women with pregnancy or other contraindications to tamoxifen.
- •Girls less than 16 years.
- •Very large lesions which require surgery for cosmesis.
- •High risk breast lesions like epitheliosis, atypia or atypical hyperplasia on histopathology or susceptible lesions prone to develop malignancy.
- •Lesions like duct ectasia where hormone therapy is not likely to be of benefit.
- •Inflammatory lesions which are amenable to antibiotic therapy or surgical drainage for treatment.
- •Patients unwilling to undergo treatment.
研究组 & 干预措施
Tamoxifen
10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
干预措施: Tamoxifen (Drug)
Evening Primrose Oil
1000 mg daily for 3 months
干预措施: Evening Primrose Oil (Drug)
结局指标
主要结局
Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)
时间窗: 3 months
Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.
Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).
时间窗: 3 months
All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response
次要结局
- Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)(3 months)
研究者
Md Tanveer Adil
Resident
Medical College and Hospital Kolkata