Clinical trial NCT02801786: TAmoxifen Versus LIdocaine Cream. A Randomized Clinical Trial for Reducing Pain and Discomfort During Mammography
Official title: Randomized Study of the Use of Tamoxifen Versus Ointment Lidocaine for Reducing the Pain and Discomfort in Mammography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pain
Discomfort
Keywords: Mammography
Premedication
Pain
Discomfort
Breast
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 450
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

All the patients will undergo at least four imaging views: one craniocaudal and one mediolateral oblique plane for each breast. When necessary, complementary imaging will be used, including selective compression, magnification or other methods.

Control variables:

* Patient's age in completed years at the time of the study;
* Time within the menstrual cycle;
* Menopausal status;
* Use of oral contraceptives;
* Use of hormone replacement therapy;
* Previous history of mastalgia;
* Number of cups of coffee drunk per day;
* Bra size;
* Weight and height, for body mass index (BMI): weight in kilograms and height in meters, according to information provided by the patient at the time of the study;
* Any previous mammographic examination.

Dependent variables:

The pain will be used to measure according to the linear visual analog pain scale. Discomfort will be recorded into four possible categories according to the patient's opinion: no discomfort, uncomfortable, very uncomfortable or intolerable.

Ethical matters:

This study was approved by the Research Ethics Committee of the university hospital of the Federal University of Goias and it will be conducted in accordance with the ruling principles of the Helsinki Convention.

Eligibility criteria: Inclusion Criteria:

* Patients with mastalgia in the mastology program with age 40 who have indication for mammography.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Tamoxifen for pain during mammography
timeFrame: Between review, test, randomization, application of results, data analysis and delivery of results for publication will be 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Universidade Federal de Goias
state: Goias
Study officials:
References:
citation: Kashikar-Zuck S, Keefe FJ, Kornguth P, Beaupre P, Holzberg A, Delong D. Pain coping and the pain experience during mammography: a preliminary study. Pain. 1997 Nov;73(2):165-172. doi: 10.1016/S0304-3959(97)00114-0.