ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cyclic mastalgia

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Pain assessed using a visual analogue scale (VAS)

Timepoint [1]

1 month post-intervention commencement, 2 months post-intervention commencement (primary endpoint),

Secondary outcome [1]

Side effects assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE4).

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Iran, Islamic Republic Of

State/province [1]

Zanjan

Country [2]

Iran, Islamic Republic Of

State/province [2]

East Azerbayjan

Country [3]

Iran, Islamic Republic Of

State/province [3]

Sistan and Baluchestan

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Daniel F Fouladi

Address [1]

Golgasht Street, Imam Reza Hospital, East Azerbaijan, Tabriz, Iran, Postal-code: 5163964159

Country [1]

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]

Individual

Name [1]

Parisa Sedighi

Address [1]

Gavazang road, Zanjan University of Medical Sciences, Zanjan Province, Zanjan, Iran. Postal-code: 451561

Country [1]

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

Dr Daniel Fouladi

Address

Tabriz University of Medical Sciences.
Adress: Golgasht Street, Imam Reza Hospital, Tabriz, Iran. Postal-code: 5163964159

Country

Iran, Islamic Republic Of

Phone

+989144122542

Fax

[email protected]

Contact person for public queries

Name

Daniel Fouladi

Address

Tabriz University of Medical Sciences.
Adress: Golgasht Street, Imam Reza Hospital, Tabriz, Iran. Postal-code: 5163964159

Country

Iran, Islamic Republic Of

Phone

+989144122542

Fax

[email protected]

Contact person for scientific queries

Name

Daniel Fouladi

Address

Tabriz University of Medical Sciences.
Adress: Golgasht Street, Imam Reza Hospital, Tabriz, Iran. Postal-code: 5163964159

Country

Iran, Islamic Republic Of

Phone

+989144122542

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	The comparison of the therapeutic effects of piroxicam gel and oral vitamin E in cyclic mastalgia.	2022	https://dx.doi.org/10.52142/omujecm.39.4.6

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically