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

U

Universidade Federal de Goias

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Discomfort
Pain

Treatments

Drug: Tamoxifen
Drug: Placebo
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02801786
TALI TRIAL

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 estimated patients

Sex

Female

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

450 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Five capsules containing placebo
Treatment:
Drug: Placebo
Tamoxifen
Experimental group
Description:
Five capsules containing 20mg of tamoxifen.
Treatment:
Drug: Tamoxifen
Drug: Placebo
Lidocaine
Experimental group
Description:
One sachet containing lidocaine gel at 4%
Treatment:
Drug: Placebo
Drug: Lidocaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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