Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02976363
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2016-11-18
Brief Title:
Maximal Respiratory Pressures After Radiotherapy
Sponsor:
Federal University of Mato Grosso
Organization:
Federal University of Mato Grosso
Study Overview
Official Title:
Study of Maximal Respiratory Pressures After Exposure to Breast Radiotherapy in Women
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 GrandeMS 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 4691341570000002 All participants signed an informed consent form after being informed about the design and objectives of the study according to Resolution 46612 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 20 was performed to classify the clinic pneumonitis according to the Common Toxicity Criteria CTC Version 20
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 students t test The comparison between the moments before and after the radiotherapy in relation to MIP and MEP was performed using the students 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 125 statistical program
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 20 was performed to classify the clinic pneumonitis according to the Common Toxicity Criteria CTC Version 20
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 students t test The comparison between the moments before and after the radiotherapy in relation to MIP and MEP was performed using the students 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 125 statistical program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None