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

May 1, 2018 updated by: Ruffo Freitas-Junior, Universidade Federal de Goias

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Goias
      • Goiania, Goias, Brazil, 74605050
        • Universidade Federal de Goias
        • Contact:
        • Principal Investigator:
          • Ruffo Freitas Junior

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Five capsules containing placebo
Drug: Placebo
The arm will be composed of 03 women who used placebo capsules and gel.
Other Names:
  • Starch
Experimental: Tamoxifen
Five capsules containing 20mg of tamoxifen.
Drug: Placebo
The arm will be composed of 03 women who used placebo capsules and gel.
Other Names:
  • Starch
Drug: 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.
Experimental: Lidocaine
One sachet containing lidocaine gel at 4%
Drug: Placebo
The arm will be composed of 03 women who used placebo capsules and gel.
Other Names:
  • Starch
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tamoxifen for pain during mammography
Time Frame: 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.
Between review, test, randomization, application of results, data analysis and delivery of results for publication will be 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Goias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TALI TRIAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe