TAmoxifen Versus LIdocaine Cream. A Randomized Clinical Trial for Reducing Pain and Discomfort During Mammography

Pain Clinical Trial

— TALI  

Official title:

Randomized Study of the Use of Tamoxifen Versus Ointment Lidocaine for Reducing the Pain and Discomfort in Mammography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02801786
• Other study ID #: TALI TRIAL
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2018
• Est. completion date: June 2021

Study information

• Verified date: May 2018
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: June 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Discomfort
• Pain

Intervention

Drug:
• Placebo
The arm will be composed of 03 women who used placebo capsules and gel.
• Lidocaine
The arm 2 will consist of women who used the placebo capsules for 5 days and 4% lidocaine gel 15 minutes before the test.
• Tamoxifen
The arm 01 is composed of patients who use tamoxifen 20mg one capsule per day for 05 days before the test and placebo gel 15 minutes before the exam.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Goias	Goiania	Goias

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Goias

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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):165-72. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tamoxifen for pain during mammography	An additional 15% of patients who did not experience pain during mammography using the medication.	Between review, test, randomization, application of results, data analysis and delivery of results for publication will be 24 months.