Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000103763
Ethics application status
Not required
Date submitted
19/08/2020
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Date results information initially provided
24/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The comparison of the effects of piroxicam gel and oral vitamin E in treating cyclic breast pain
Scientific title
The comparison of the therapeutic effects of piroxicam gel and oral vitamin E in cyclic mastalgia
Secondary ID [1] 302071 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cyclic mastalgia 322112 0
Condition category
Condition code
Reproductive Health and Childbirth 316688 316688 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical 0.5% piroxicam gel, 4 times daily, liberal amount applied to point of tenderness plus oral placebo capsule containing glucose taken once daily in one group for 2 consecutive months.

To monitor adherence, patients will be asked to self report weekly.
Intervention code [1] 318370 0
Treatment: Drugs
Comparator / control treatment
Oral vitamin E, 400U, taken once daily plus topical placebo gel (silicone), 4 times daily, liberal amount applied to point of tenderness in the other group for 2 consecutive months.

To monitor adherence, patients will be asked to self report weekly.
Control group
Placebo

Outcomes
Primary outcome [1] 324816 0
Pain assessed using a visual analogue scale (VAS)
Timepoint [1] 324816 0
1 month post-intervention commencement, 2 months post-intervention commencement (primary endpoint),
Secondary outcome [1] 385844 0
Side effects assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE4).
Timepoint [1] 385844 0
1 month post-intervention commencement.

Eligibility
Key inclusion criteria
Patients with cyclic mastalgia of grade 3 or more on visual analogue scale requiring treatment
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-Pregnancy
-Concomitant or previous medical condition
-Irregular menses
-Presence of evidences indicating an underlying etiology for the breast pain by physical examination and/or in imaging studies
-Positive allergy to the used medications or placebos

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Repeated Measures Analysis
Chi-square/Exact Fisher

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/01/2020
Date of last participant enrolment
Anticipated
Actual
2/03/2020
Date of last data collection
Anticipated
Actual
12/07/2020
Sample size
Target
70
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 22862 0
Iran, Islamic Republic Of
State/province [1] 22862 0
Zanjan
Country [2] 23731 0
Iran, Islamic Republic Of
State/province [2] 23731 0
East Azerbayjan
Country [3] 24161 0
Iran, Islamic Republic Of
State/province [3] 24161 0
Sistan and Baluchestan

Funding & Sponsors
Funding source category [1] 306490 0
Self funded/Unfunded
Name [1] 306490 0
Daniel F Fouladi
Country [1] 306490 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Daniel F Fouladi
Address
Golgasht Street, Imam Reza Hospital, East Azerbaijan, Tabriz, Iran. Postal-code: 5163964159
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 307014 0
Individual
Name [1] 307014 0
Parisa Sedighi
Address [1] 307014 0
Gavazang road, Zanjan University of Medical Sciences, Zanjan Province, Zanjan, Iran. Postal-code: 451561
Country [1] 307014 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Not required

Summary
Brief summary
In this study, we compare the effectiveness (in reducing pain) and side effects of two types of routinely used treatments for cyclic breast pain: one treatment with oral vitamin E capsules and the other treatment with topical piroxicam gel.

Trial website
Trial related presentations / publications
Public notes
Ethics approval is not required because we are comparing two routine treatments of cyclic mastalgia with each other.
First, we provide the patients with details about the available treatments for cyclic mastalgia. When there is not a preference by the patient after receiving adequate information, that patient is randomly assigned to one of the treatment wings. There is no extra intervention in this study. Adequate advice in this regard was received by the Ethics Committee of Zanjan University of Medical Sciences before the proposal is submitted for registration (4/7/2019). According to this advice, as far as the participants are anonymous and they have no preference over the type of treatment they would receive, there would be no other ethical concerns in this study.

Contacts
Principal investigator
Name 104702 0
Dr Daniel Fouladi
Address 104702 0
Tabriz University of Medical Sciences.
Adress: Golgasht Street, Imam Reza Hospital, Tabriz, Iran. Postal-code: 5163964159
Country 104702 0
Iran, Islamic Republic Of
Phone 104702 0
+989144122542
Fax 104702 0
Email 104702 0
[email protected]
Contact person for public queries
Name 104703 0
Dr Daniel Fouladi
Address 104703 0
Tabriz University of Medical Sciences.
Adress: Golgasht Street, Imam Reza Hospital, Tabriz, Iran. Postal-code: 5163964159
Country 104703 0
Iran, Islamic Republic Of
Phone 104703 0
+989144122542
Fax 104703 0
Email 104703 0
[email protected]
Contact person for scientific queries
Name 104704 0
Dr Daniel Fouladi
Address 104704 0
Tabriz University of Medical Sciences.
Adress: Golgasht Street, Imam Reza Hospital, Tabriz, Iran. Postal-code: 5163964159
Country 104704 0
Iran, Islamic Republic Of
Phone 104704 0
+989144122542
Fax 104704 0
Email 104704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe comparison of the therapeutic effects of piroxicam gel and oral vitamin E in cyclic mastalgia.2022https://dx.doi.org/10.52142/omujecm.39.4.6
N.B. These documents automatically identified may not have been verified by the study sponsor.