Respiratory Function TestsNCT02976363
Maximal Respiratory Pressures After Radiotherapy
An observational study of Respiratory Function Tests, run by Federal University of Mato Grosso.
Trial summary
Objective: The purpose of this research was to study the Maximal Respiratory Pressures (MRP) after exposure to breast radiation therapy in women. Methods: Prospective observational study performed at the Hospital de cancer Alfred in Campo Grande/MS. 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
- Respiratory Function Tests
- What is being tested?
- Radiotherapy breast cancer and Evaluation Maximal Respiratory Pressures
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Feb 2016
- Phase
- Observational
- 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
Study population: The quadrantectomy group (QG) participants were selected consecutively among patients who initiated radiotherapy. While the control group (CG) was selected during routine exams of he image sector from Hospital de Cancer Alfred Abrão.
Who may be able to join
- There were selected women aged 40-70 years old, breast quadrantectomy post-surgery and adjuvant radiotherapy indication to compose the experimental group.
- While for the control group women aged 40-70 years old with no breast cancer history were invited.
Who cannot join
- The exclusion of the experimental and control groups were based on the following criteria:
- lung disease association, central or peripheral neurological disorders, refusal to participate in the study, difficulties in understanding and the completion of the protocol tests.
- The unique criteria of the experimental group were: metastatic cancer, concomitant chemotherapy to radiotherapy, hormone therapy and withdrawal of treatment.
About this study
Official title: Study of Maximal Respiratory Pressures After Exposure to Breast Radiotherapy in Women
Objective: The purpose of this research was to study the Maximal Respiratory Pressures (MRP) after exposure to breast radiation therapy in women. Methods: Prospective observational study performed at the Hospital de cancer Alfred in Campo Grande/MS. The sample of this study consisted of women (N = 16) divided into two groups: women exposed to breast radiotherapy after underwent quadrantectomy surgery (n = 8); and women with no history of cancer (n = 8). We evaluated the strength of respiratory muscles through the Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) using the handset called manovacuometer. The examination was performed before the first session and after the twenty-fifth session related to the last day of the radiation treatment; evaluation of anthropometric data of weight and height to detect the body mass index (BMI); evaluation of clinical respiratory symptoms of dyspnea using the Medical Research Council (MRC) Dyspnea Scale and characterization of cough with Common Pulmonary Toxicity Criteria, in the classification of clinical pneumonitis.
Read the detailed description
Study design and sample The research consisted of an observational prospective study with control group. The study was approved by the Ethics Committee of the Federal University of Mato Grosso do Sul (UFMS) with the number 46913415.7.0000.002. All participants signed an informed consent form after being informed about the design and objectives of the study according to Resolution 466/12 of the National Council of Health Ministry of Health (CNS).
The quadrantectomy group participants were selected consecutively among patients who initiated radiotherapy. While the control group was selected during routine exams of he image sector from Hospital de Cancer Alfred Abrão.
Research site The execution of the research took place in the Radiotherapy sector of Hospital de Cancer Alfred Abrão in Campo Grande - Mato Grosso do Sul state, from December 2015 to February 2016.
Radiotherapy Protocol The Quadrantectomy Group sample performed adjuvant radiotherapy with a linear accelerator, whose the total dosage was 5000 centigray (cGy), the daily dose 200 cGy distributed into twenty-five sessions, totaling 25 days of treatment.
PROCEDURES Evaluation of maximal respiratory pressures (MRP) Quantification of MIP and MEP was performed with the portable device called manometer, Wika brand with pressure scale ranging from -150 to 150 centimeters of water (0 to -150 to (0 to -150 for MIP; 0 to 150 for MEP). The mouthpiece attached to the device had a hole of 2 mm in diameter, in order to function as a relief valve of the facial muscles. During the measurement of maximal respiratory pressures, the survey participants remained in seated position with the trunk in a 90 ° angle with the lower limbs. A forced expiration was requested until reaching the residual volume (RV) for the measurement of MIP, followed by a maximal inspiratory effort against the occluded airway (Maneuver Muller), this maneuver kept for up to 2 seconds. While the evaluation of MEP, a maximum inspiration was requested to Total Lung Capacity (TLC), followed by a maximal expiratory effort against the occluded airway (Muller maneuver), maintained for up to 2 seconds.
Data from Maximal Respiratory Pressures were collected at two phases in the sample of quadrantectomy group: before the first session of radiotherapy and after the twenty-fifth session corresponding to the last day of the radiotherapy treatment.
The evaluation of the MRP was performed according to the Brazilian Guidelines for Pulmonary Function Tests. The results were analyzed according to the predictive values of Neder regression equations (1999).
Complementary evaluation Anthropometric data evaluated to detect the body mass index (BMI) were: weight and height. Evaluation of dyspnea and cough symptoms with modified Dyspnea Medical Research Council scale (MRC) with the Common Pulmonary Toxicity Common Criteria scale (CTC Version 2.0) was performed to classify the clinic pneumonitis according to the Common Toxicity Criteria (CTC Version 2.0).
Statistics The variables classified as dependent were the maximal respiratory pressures. While the independent variables were sex, age, weight, height, BMI.
The comparison data analysis between the control group and quadrantectomy in relation to the variables: age, height, weight, BMI, MIP and MEP, was performed using the student's t test. The comparison between the moments before and after the radiotherapy in relation to MIP and MEP was performed using the student's t test paired, considering a 5% significance level. The other results of this study were presented in the form of descriptive statistics or in tables and graphics. Statistical analysis was performed using the sigma plot version 12.5 statistical program.
- Conditions
- Respiratory Function Tests
- Being tested
- Radiotherapy breast cancer, Evaluation Maximal Respiratory Pressures
- Keywords
- Radiotherapy, Respiratory muscles, Neoplasms, Breast
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy breast cancerRadiation
Evaluation Maximal Respiratory PressuresOther
Also called MIP and MEP
| Study group | Role | What they receive |
|---|---|---|
| Quadrantectomy Group | The Quadrantectomy Group sample performed adjuvant radiotherapy with a linear accelerator, whose the total dosage was 5000 centigray (cGy), the daily dose 200 cGy distributed into twenty-five sessions, totaling 25 days of treatment. And data from Maximal Respiratory Pressures (MIP/MEP) were collected at two phases in the sample of Quadrantectomy Group: before the first session of radiotherapy and after the twenty-fifth session corresponding to the last day of the radiotherapy treatment. Receives: Radiation: Radiotherapy breast cancer; Other: Evaluation Maximal Respiratory Pressures | |
| Control Group | While for the control group women with no breast cancer history were invited. Data from Maximal Respiratory Pressures (MIP/MEP) were collected at one phase in the sample of control group. Receives: Other: Evaluation Maximal Respiratory Pressures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Respiratory Pressures (MRP) after exposure to breast radiation therapy in women
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory Function TestsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Mato Grosso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thays Mello de Avila, Federal University of Mato Grosso
- Investigators
- Thays M Avila, Principal investigator, UFMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976363
- Sponsor's protocol ID
- 46913415700000021
- Status last verified
- Nov 2016
- First submitted
- 18 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.
PubMed 5772056Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
PubMed 10412550Spyropoulou D, Leotsinidis M, Tsiamita M, Spiropoulos K, Kardamakis D. Pulmonary function testing in women with breast cancer treated with radiotherapy and chemotherapy. In Vivo. 2009 Sep-Oct;23(5):867-71.
PubMed 19779125Lee TF, Chao PJ, Chang L, Ting HM, Huang YJ. Developing Multivariable Normal Tissue Complication Probability Model to Predict the Incidence of Symptomatic Radiation Pneumonitis among Breast Cancer Patients. PLoS One. 2015 Jul 6;10(7):e0131736. doi: 10.1371/journal.pone.0131736. eCollection 2015.
PubMed 26147496
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Maximal Respiratory Pressures After Exposure to Breast Radiotherapy in Women
- ClinicalTrials.gov ID
- NCT02976363
- Acronym / sponsor ID
- 46913415700000021
- Conditions
- Respiratory Function Tests
- Keywords
- Radiotherapy, Respiratory muscles, Neoplasms, Breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Federal University of Mato GrossoUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Nov 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.
Objective: The purpose of this research was to study the Maximal Respiratory Pressures (MRP) after exposure to breast radiation therapy in women. Methods: Prospective observational study performed at the Hospital de cancer Alfred in Campo Grande/MS. The sample of this study consisted of women (N = 16) divided into two groups: women exposed to breast radiotherapy after underwent quadrantectomy surgery (n = 8); and women with no history of cancer (n = 8). We evaluated the strength of respiratory muscles through the Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) using the handset called manovacuometer. The examination was performed before the first session and after the twenty-fifth session related to the last day of the radiation treatment; evaluation of anthropometric data of weight and height to detect the body mass index (BMI); evaluation of clinical respiratory symptoms of dyspnea using the Medical Research Council (MRC) Dyspnea Scale and characterization of cough with Common Pulmonary Toxicity Criteria, in the classification of clinical pneumonitis.
Detailed description
Study design and sample The research consisted of an observational prospective study with control group. The study was approved by the Ethics Committee of the Federal University of Mato Grosso do Sul (UFMS) with the number 46913415.7.0000.002. All participants signed an informed consent form after being informed about the design and objectives of the study according to Resolution 466/12 of the National Council of Health Ministry of Health (CNS).
The quadrantectomy group participants were selected consecutively among patients who initiated radiotherapy. While the control group was selected during routine exams of he image sector from Hospital de Cancer Alfred Abrão.
Research site The execution of the research took place in the Radiotherapy sector of Hospital de Cancer Alfred Abrão in Campo Grande - Mato Grosso do Sul state, from December 2015 to February 2016.
Radiotherapy Protocol The Quadrantectomy Group sample performed adjuvant radiotherapy with a linear accelerator, whose the total dosage was 5000 centigray (cGy), the daily dose 200 cGy distributed into twenty-five sessions, totaling 25 days of treatment.
PROCEDURES Evaluation of maximal respiratory pressures (MRP) Quantification of MIP and MEP was performed with the portable device called manometer, Wika brand with pressure scale ranging from -150 to 150 centimeters of water (0 to -150 to (0 to -150 for MIP; 0 to 150 for MEP). The mouthpiece attached to the device had a hole of 2 mm in diameter, in order to function as a relief valve of the facial muscles. During the measurement of maximal respiratory pressures, the survey participants remained in seated position with the trunk in a 90 ° angle with the lower limbs. A forced expiration was requested until reaching the residual volume (RV) for the measurement of MIP, followed by a maximal inspiratory effort against the occluded airway (Maneuver Muller), this maneuver kept for up to 2 seconds. While the evaluation of MEP, a maximum inspiration was requested to Total Lung Capacity (TLC), followed by a maximal expiratory effort against the occluded airway (Muller maneuver), maintained for up to 2 seconds.
Data from Maximal Respiratory Pressures were collected at two phases in the sample of quadrantectomy group: before the first session of radiotherapy and after the twenty-fifth session corresponding to the last day of the radiotherapy treatment.
The evaluation of the MRP was performed according to the Brazilian Guidelines for Pulmonary Function Tests. The results were analyzed according to the predictive values of Neder regression equations (1999).
Complementary evaluation Anthropometric data evaluated to detect the body mass index (BMI) were: weight and height. Evaluation of dyspnea and cough symptoms with modified Dyspnea Medical Research Council scale (MRC) with the Common Pulmonary Toxicity Common Criteria scale (CTC Version 2.0) was performed to classify the clinic pneumonitis according to the Common Toxicity Criteria (CTC Version 2.0).
Statistics The variables classified as dependent were the maximal respiratory pressures. While the independent variables were sex, age, weight, height, BMI.
The comparison data analysis between the control group and quadrantectomy in relation to the variables: age, height, weight, BMI, MIP and MEP, was performed using the student's t test. The comparison between the moments before and after the radiotherapy in relation to MIP and MEP was performed using the student's t test paired, considering a 5% significance level. The other results of this study were presented in the form of descriptive statistics or in tables and graphics. Statistical analysis was performed using the sigma plot version 12.5 statistical program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadrantectomy Group | – | Radiation: Radiotherapy breast cancer, Other: Evaluation Maximal Respiratory PressuresThe Quadrantectomy Group sample performed adjuvant radiotherapy with a linear accelerator, whose the total dosage was 5000 centigray (cGy), the daily dose 200 cGy distributed into twenty-five sessions, totaling 25 days of treatment. And data from Maximal Respiratory Pressures (MIP/MEP) were collected at two phases in the sample of Quadrantectomy Group: before the first session of radiotherapy and after the twenty-fifth session corresponding to the last day of the radiotherapy treatment. |
| Control Group | – | Other: Evaluation Maximal Respiratory PressuresWhile for the control group women with no breast cancer history were invited. Data from Maximal Respiratory Pressures (MIP/MEP) were collected at one phase in the sample of control group. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The quadrantectomy group (QG) participants were selected consecutively among patients who initiated radiotherapy. While the control group (CG) was selected during routine exams of he image sector from Hospital de Cancer Alfred Abrão.
Key inclusion criteria (2 listed)
- There were selected women aged 40-70 years old, breast quadrantectomy post-surgery and adjuvant radiotherapy indication to compose the experimental group.
- While for the control group women aged 40-70 years old with no breast cancer history were invited.
Key exclusion criteria (3 listed)
- The exclusion of the experimental and control groups were based on the following criteria:
- lung disease association, central or peripheral neurological disorders, refusal to participate in the study, difficulties in understanding and the completion of the protocol tests.
- The unique criteria of the experimental group were: metastatic cancer, concomitant chemotherapy to radiotherapy, hormone therapy and withdrawal of treatment.
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 |
|---|---|---|
| Radiotherapy breast cancer | Radiation | Quadrantectomy Group |
| Evaluation Maximal Respiratory PressuresAlso: MIP and MEP | Other | Control Group, Quadrantectomy Group |
Primary outcome
Maximal Respiratory Pressures (MRP) after exposure to breast radiation therapy in women
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Background: PubMed 5772056Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.
- Background: PubMed 10412550Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
- Background: PubMed 19779125Spyropoulou D, Leotsinidis M, Tsiamita M, Spiropoulos K, Kardamakis D. Pulmonary function testing in women with breast cancer treated with radiotherapy and chemotherapy. In Vivo. 2009 Sep-Oct;23(5):867-71.
- Background: PubMed 26147496Lee TF, Chao PJ, Chang L, Ting HM, Huang YJ. Developing Multivariable Normal Tissue Complication Probability Model to Predict the Incidence of Symptomatic Radiation Pneumonitis among Breast Cancer Patients. PLoS One. 2015 Jul 6;10(7):e0131736. doi: 10.1371/journal.pone.0131736. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
Thays M Avila principal investigator
UFMS
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Function Tests, run by Federal University of Mato Grosso.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Respiratory Pressures (MRP) after exposure to breast radiation therapy in women (time frame: three 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 NCT02976363, which also lists 4 linked publications.
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 29 Nov 2016.