Maximal Respiratory Pressures After Radiotherapy

NCT02976363 | Completed

• 1 other identifier: 46913415700000021
• Study Type: observational
• Target: 16
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Respiratory Function Tests

Keywords

Radiotherapy; Respiratory muscles; Neoplasms; Breast

Outcome Measures

Primary Outcomes (1)

• Maximal Respiratory Pressures (MRP) after exposure to breast radiation therapy in women

  three months

Study Arms (2)

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.

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.

Other: Evaluation Maximal Respiratory Pressures

Interventions

Radiotherapy breast cancer RADIATION

Quadrantectomy Group

Evaluation Maximal Respiratory Pressures OTHER

Also known as: MIP and MEP

Control Group; Quadrantectomy Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Mato Grosso: lead

Related Publications (4)

• 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.

  PMID: 5772056 BACKGROUND

• Neder 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.

  PMID: 10412550 BACKGROUND

• Spyropoulou 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.

  PMID: 19779125 BACKGROUND

• Lee 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.

  PMID: 26147496 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Thays M Avila

  UFMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 29, 2016
• Study Start: December 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share