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

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ClinicalTrials.gov Identifier: NCT02801786
Recruitment Status : Not yet recruiting
First Posted : June 16, 2016
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Ruffo Freitas-Junior, Universidade Federal de Goias

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.

Condition or disease Intervention/treatment Phase
Pain Discomfort Drug: Placebo Drug: Lidocaine Drug: Tamoxifen Phase 2 Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Study of the Use of Tamoxifen Versus Ointment Lidocaine for Reducing the Pain and Discomfort in Mammography
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801786


Locations
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Brazil
Universidade Federal de Goias Not yet recruiting
Goiania, Goias, Brazil, 74605050
Contact: Ruffo Freitas    556281885540    ruffojr@terra.com.br   
Principal Investigator: Ruffo Freitas Junior         
Sponsors and Collaborators
Universidade Federal de Goias

Publications of Results:
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Responsible Party: Ruffo Freitas-Junior, Responsible Party was entered in the old format as Ruffo Freitas-Junior,Federal University of Goias., Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT02801786     History of Changes
Other Study ID Numbers: TALI TRIAL
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

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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
Keywords provided by Ruffo Freitas-Junior, Universidade Federal de Goias:
Mammography
Premedication
Pain
Discomfort
Breast
Additional relevant MeSH terms:
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Tamoxifen
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents