Effect of CCRT on Respiratory Performance and Functional Capacity in Esophagus Cancer Patients
Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Primary Esophagus Cancer
調査の概要
詳細な説明
Background and Purpose: Incidence rates of esophageal cancer vary internationally with the higher rate found in Eastern Asia. Preoperative concurrent chemoradiation therapy (CCRT) for resectable esophageal cancer has been shown to improve overall survival in meta-analyses. Preoperative pulmonary function and functional capacity are known predictive factors for the development of postoperative pulmonary complications in patient undergoing major cancer surgery. Little is known concerning the impacts of preoperative CCRT on pulmonary function and functional capacity in patients with esophageal cancer. The aim of this study is to examine changes of respiratory performance and functional exercise capacity during RT or CCRT, the relations between these changes, and the impacts of these changes on the postoperative outcomes in patients with esophageal cancer.
Method: Patients with newly diagnosed esophageal cancer without metastasis will be recruited from the Far Eastern Memorial Hospital. Demographic data will be obtained from the chart. Respiratory muscle strength will be measured by maximal inspiratory and expiratory pressure. Spirometric variables will be tested by force expiratory volume in one second and forced vital capacity. Dyspnea will be measured using modified Borg scale. Functional exercise capacity will be measured by six minute walk distance. Quality of life will be measured using EORTC QOL-C30 and QOL-OES18 instruments. All the measurements will be repeated weekly during the concurrent therapy period. Repeated measure ANOVA will be used for analyzing difference among various time points. Spearman correlation coefficient will be used to test relationship between multiple variables. For patients who are receiving esophagectomy after CCRT or RT, pulmonary complications and total length of hospital stay will be documented.
Clinical relevance: The results of this study will help to better understand the indications for chest physiotherapy (e.g., respiratory muscle weakness, reduced functional capacity, and their related sequels)
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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New Taipei City、台湾
- Far Eastern Memorial Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- primary esophagus cancer
- planning to receive radiation therapy
Exclusion Criteria:
- MMSE < 24
- A clinical diagnosis affecting respiratory muscle function and functional activity performance
- Unstable angina or acute myocardial infarction prior 1 month of assessment
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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esophagus cancer patients
Respiratory muscle performance will be followed in patients with esophagus cancer during CCRT or RT treatments.
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Respiratory muscle performance will include measurements of respiratory muscle strength and pulmonary function testing.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes of respiratory muscle performance (MIP/MEP, PFT)from baseline
時間枠：Baseline, during CCRT or RT treatment (Day 5, Day 10, Day 15, Day 20, Day 25), 2 weeks after the completion of the treatment, 1 day pre-operation, and 1 month after operation
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Maximum inspiratory pressure (MIP) Maximum expiratory pressure (MEP) PFT: FEV1, FVC, FEV1/FVC
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Baseline, during CCRT or RT treatment (Day 5, Day 10, Day 15, Day 20, Day 25), 2 weeks after the completion of the treatment, 1 day pre-operation, and 1 month after operation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes of functional exercise capacity, dyspnea, and quality of life from baseline
時間枠：Baseline, during CCRT or RT treatment (Day 5, Day 10, Day 15, Day 20, Day 25), 2 weeks after the completion of the treatment, 1 day pre-operation, and 1 month after operation
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Functional exercise capacity will be measured using six-minute walk test.
Modified Borg scale will be used to measure dyspnea.
EORTC QOL-C30 and QOL-OES18 instruments will be used to measure Quality of life.
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Baseline, during CCRT or RT treatment (Day 5, Day 10, Day 15, Day 20, Day 25), 2 weeks after the completion of the treatment, 1 day pre-operation, and 1 month after operation
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Prevalence of pulmonary complications
時間枠：During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
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Data will be retrieved from the chart.
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During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
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Total length of hospital stay
時間枠：During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
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Data will be retrieved from the chart.
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During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
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協力者と研究者
捜査官
- 主任研究者：Chen-Hsi Hsieh, MD., Ph.D.、Department of Radiation Oncology, Far Eastern Memorial Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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