Randomized Study of the Use of Tamoxifen Versus Ointment Lidocaine for Reducing the Pain and Discomfort in Mammography
试验速览
- 阶段
- 2 期
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Tamoxifen for pain during mammography
研究概览
简要总结
This is a double-blind placebo-controlled randomized clinical trial to test the use of tamoxifen or lidocaine for diminishing the pain and discomfort while performing mammography, intending to include 450 patients distributed between the three groups.
详细描述
This is a double-blind placebo-controlled randomized clinical trial to test the use of tamoxifen or lidocaine for diminishing the pain and discomfort while performing mammography, intending to include 450 patients distributed between the three groups.
Inclusion criteria:Patients presenting mastalgia with a prior indication for mammography who is over 40 years old, undergoing their radiological examination at the university hospital of the Federal University of Goias. The only patients who were not included were those who did not wish to participate in the study.
The patients will receive:
- Group 1:Five capsules containing 20mg of tamoxifen plus one sachet containing gel placebo;
- Group 2: Five capsules containing placebo and one sachet containing lidocaine gel at 4%;
- Group 3: Five capsules containing placebo plus one sachet containing gel placebo.
Mammography procedures: The mammography at the university hospital was carried out using a high-resolution mammograph with mean compression in each plane of approximately 800 newtons.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with mastalgia in the mastology program with age 40 who have indication for mammography.
排除标准
- •Patients who do not wish to participate in the study
- •Patients who underwent prosthetic silicone implants
- •Patients who mammoplasty (breast reduction or mastopexy) were submitted
- •Pregnant women
- •Patients allergic to tamoxifen or to lidocaine, heart disease, or patients with a history deep vein thrombosis.
研究组 & 干预措施
Placebo
Five capsules containing placebo
干预措施: Placebo (Drug)
Tamoxifen
Five capsules containing 20mg of tamoxifen.
干预措施: Placebo (Drug)
Tamoxifen
Five capsules containing 20mg of tamoxifen.
干预措施: Tamoxifen (Drug)
Lidocaine
One sachet containing lidocaine gel at 4%
干预措施: Placebo (Drug)
Lidocaine
One sachet containing lidocaine gel at 4%
干预措施: Lidocaine (Drug)
结局指标
主要结局
Tamoxifen for pain during mammography
时间窗: Between review, test, randomization, application of results, data analysis and delivery of results for publication will be 24 months.
An additional 15% of patients who did not experience pain during mammography using the medication.
次要结局
未报告次要终点
研究者
Ruffo Freitas-Junior
Responsible Party was entered in the old format as Ruffo Freitas-Junior,Federal University of Goias.
Universidade Federal de Goias