Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000122954
Ethics application status
Approved
Date submitted
13/07/2010
Date registered
3/02/2011
Date last updated
18/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of pulmonary function conditions pre-radiotherapy in breast cancer treatment.
Scientific title
A single group study on early detection of functional pulmonary loss before radiotherapy on breast cancer patients.
Secondary ID [1] 252197 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional pulmonary loss. 257730 0
Breast cancer. 257733 0
Condition category
Condition code
Cancer 257903 257903 0 0
Breast
Respiratory 257904 257904 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients’ pulmonary function was evaluated immediately before they were submitted to radiotherapy, using clinical instruments, such as incentive spirometers, manuvacuometer, peak flow, and six minute walk test. Each patient was assessed once only and the duration of the evaluation was thirty minutes.
Intervention code [1] 256792 0
Early detection / Screening
Comparator / control treatment
N/A this is a single group study. Each patient’s pulmonary function was compared to their own normative value.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258766 0
Primary Outcome: loss of pulmonary function evaluated with incentive spirometers (IC, FVC), manuvacuometer (Pimax and Pemax.), peak flow (FP).
Timepoint [1] 258766 0
Timepoint: immediately before radiotherapy.
Secondary outcome [1] 264825 0
Secondary Outcome: comparing chemotherapy adjuvant and neoadjuvant influence in loss of pulmonary function evaluated with incentive spirometers (IC, FVC), manuvacuometer (Pimax and Pemax.), peak flow (FP).
Timepoint [1] 264825 0
Timepoint: immediately before radiotherapy.

Eligibility
Key inclusion criteria
Documented breast cancer diagnosis, operated, with radiotherapy proposition as an adjuvant treatment, after chemotherapy and/or hormone therapy neoadjuvant or adjuvant, no past or present clinical evidence of benign or malign pulmonary disease based on oncological follow up and previous history and cognitive capacity to understand simple commands and to execute tasks during testing.
Minimum age
35 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who were submitted to radiotherapy concomitant to chemotherapy were excluded from the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/04/2008
Actual
22/04/2008
Date of last participant enrolment
Anticipated
23/06/2009
Actual
23/06/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 2758 0
Brazil
State/province [1] 2758 0
Minas Gerais (MG)

Funding & Sponsors
Funding source category [1] 257278 0
Self funded/Unfunded
Name [1] 257278 0
unfunded
Country [1] 257278 0
Primary sponsor type
Individual
Name
Renata de Carvalho Schettino
Address
Matipo street, 177/202 Santo Antonio cep:30350-210
BH-MG
Country
Brazil
Secondary sponsor category [1] 256520 0
Individual
Name [1] 256520 0
Karla de Carvalho Schettino
Address [1] 256520 0
Matipo street, 177/202 Santo Antonio cep:30350-210
BH-MG
Country [1] 256520 0
Brazil
Secondary sponsor category [2] 256521 0
Individual
Name [2] 256521 0
Geovanni Dantas Cassali
Address [2] 256521 0
Av. Pres. Antonio Carlos 6627 Pampulha- Instituto de Ciencias Biologicas- Cep: 31270-901 BH-MG
Country [2] 256521 0
Brazil
Other collaborator category [1] 251384 0
Individual
Name [1] 251384 0
Miguel Torres Teixeira Leite
Address [1] 251384 0
Av. Pres. Antonio Carlos 6627 Pampulha- Instituto de Ciencias Biologicas- Cep: 31270-901 BH-MG
Country [1] 251384 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260393 0
Comite de etica em pesquisa da Universidade Federal de Minas Gerais - COEP UFMG
Ethics committee address [1] 260393 0
Av. Pres. Antonio Carlos 6627 Pampulha unidade Administrativa II sala 2005 Cep: 31270-901 BH-MG
Ethics committee country [1] 260393 0
Brazil
Date submitted for ethics approval [1] 260393 0
29/11/2007
Approval date [1] 260393 0
16/04/2008
Ethics approval number [1] 260393 0
ETIC CAAE-0605.0.203.000-07

Summary
Brief summary
The aim of this study was to transversally detect, by means of routinely used physiotherapeutic instruments and a functional test, alterations in pulmonary functions due to the systemic treatments pre-radiotherapy in breast cancer treatment. Women submitted to breast cancer systemic treatments show a decrease in pulmonary function, which impairs their respiratory conditions pre-radiotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31385 0
Mrs Renata de Carvalho Schettino
Address 31385 0
Universidade Federal de Minas Gerais (UFMG)
Rua Matipo 177/202
Bairro Santo Antonio
BH-MG
CEP 30350210
Country 31385 0
Brazil
Phone 31385 0
+55 31 33441161
Fax 31385 0
+55 31 34092879
Email 31385 0
[email protected]
Contact person for public queries
Name 14632 0
Mrs Renata de Carvalho Schettino
Address 14632 0
Matipo street, 177/202 Santo Antonio Cep:30350-210 BH-MG
Country 14632 0
Brazil
Phone 14632 0
+55 31 33441161
Fax 14632 0
+55 31 34092879
Email 14632 0
[email protected]
Contact person for scientific queries
Name 5560 0
Mrs Renata de Carvalho Schettino
Address 5560 0
Matipo street, 177/202 Santo Antonio Cep:30350-210 BH-MG
Country 5560 0
Brazil
Phone 5560 0
+55 31 33441161
Fax 5560 0
+55 31 34092879
Email 5560 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.