TAmoxifen Versus LIdocaine Cream. A Randomized Clinical Trial for Reducing Pain and Discomfort During Mammography
TALI
Randomized Study of the Use of Tamoxifen Versus Ointment Lidocaine for Reducing the Pain and Discomfort in Mammography
1 other identifier
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pain
Started Nov 2018
Typical duration for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedMay 4, 2018
May 1, 2018
2 years
June 13, 2016
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (3)
Placebo
PLACEBO COMPARATORFive capsules containing placebo
Tamoxifen
EXPERIMENTALFive capsules containing 20mg of tamoxifen.
Lidocaine
EXPERIMENTALOne sachet containing lidocaine gel at 4%
Interventions
The arm will be composed of 03 women who used placebo capsules and gel.
The arm 2 will consist of women who used the placebo capsules for 5 days and 4% lidocaine gel 15 minutes before the test.
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.
Eligibility Criteria
You may qualify if:
- Patients with mastalgia in the mastology program with age 40 who have indication for mammography.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Goias
Goiânia, Goiás, 74605050, Brazil
Related 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):165-172. doi: 10.1016/S0304-3959(97)00114-0.
PMID: 9415502RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Responsible Party was entered in the old format as Ruffo Freitas-Junior,Federal University of Goias.
Study Record Dates
First Submitted
June 13, 2016
First Posted
June 16, 2016
Study Start
November 1, 2018
Primary Completion
November 1, 2020
Study Completion
June 1, 2021
Last Updated
May 4, 2018
Record last verified: 2018-05