PainPhase 2/3TALINCT02801786
TAmoxifen Versus LIdocaine Cream. A Randomized Clinical Trial for Reducing Pain and Discomfort During Mammography
A Phase 2/3 study testing Lidocaine and Tamoxifen in people with Pain and Discomfort, run by Universidade Federal de Goias at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Discomfort
- What is being tested?
- Lidocaine and Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2018to Jun 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with mastalgia in the mastology program with age 40 who have indication for mammography.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Goias
Goiânia, Goiás, 74605050
Ruffo Freitas, 556281885540, ruffojr@terra.com.br
Ruffo Freitas Junior
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Discomfort
- Keywords
- Mammography, Premedication, Pain, Discomfort, Breast
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Starch
The arm will be composed of 03 women who used placebo capsules and gel.
LidocaineDrug
The arm 2 will consist of women who used the placebo capsules for 5 days and 4% lidocaine gel 15 minutes before the test.
TamoxifenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Five capsules containing placebo Receives: Drug: Placebo |
| Tamoxifen | Experimental | Five capsules containing 20mg of tamoxifen. Receives: Drug: Placebo; Drug: Tamoxifen |
| Lidocaine | Experimental | One sachet containing lidocaine gel at 4% Receives: Drug: Placebo; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tamoxifen for pain during mammography
An additional 15% of patients who did not experience pain during mammography using the medication.
Measured: Between review, test, randomization, application of results, data analysis and delivery of results for publication will be 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startNov 2018 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruffo Freitas-Junior, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801786
- Sponsor's protocol ID
- TALI TRIAL
- Acronym
- TALI
- Status last verified
- May 2018
- First submitted
- 13 Jun 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9415502
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of the Use of Tamoxifen Versus Ointment Lidocaine for Reducing the Pain and Discomfort in Mammography
- ClinicalTrials.gov ID
- NCT02801786
- Acronym / sponsor ID
- TALI / TALI TRIAL
- Conditions
- Pain, Discomfort
- Keywords
- Mammography, Premedication, Pain, Discomfort, Breast
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboFive capsules containing placebo |
| Tamoxifen | Experimental | Drug: Placebo, Drug: TamoxifenFive capsules containing 20mg of tamoxifen. |
| Lidocaine | Experimental | Drug: Placebo, Drug: LidocaineOne sachet containing lidocaine gel at 4% |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mastalgia in the mastology program with age 40 who have indication for mammography.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: StarchThe arm will be composed of 03 women who used placebo capsules and gel. | Drug | Lidocaine, Placebo, Tamoxifen |
| LidocaineThe arm 2 will consist of women who used the placebo capsules for 5 days and 4% lidocaine gel 15 minutes before the test. | Drug | Lidocaine |
| TamoxifenThe 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. | Drug | Tamoxifen |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Results publication: PubMed 9415502Kashikar-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lidocaine and Tamoxifen in people with Pain and Discomfort, run by Universidade Federal de Goias at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02801786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.