Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy (ReDyOR)
2020年9月18日 更新者：Esther Marco Navarro、Parc de Salut Mar
Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial
Head and neck cancer has a negative impact in swallowing function and quality of life.
Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies suggest that interventions should be initiated prior to RT sessions.
This study aims to evaluate the effects of prophylactic rehabilitation on swallowing and quality of life.
The study pretends to establish a preventive rehabilitative program with the target of reducing RT side effects and improve patients' quality of life.
調査の概要
詳細な説明
Head and neck cancer has a negative impact in swallowing function and quality of life. Although current diagnostic and therapeutic protocols try to preserve swallowing and speaking, acute or late dysphagia as well as a poor quality of life are frequent in these patients.
Some studies have reported an improvement in swallowing function after an exercise based intervention following radiation therapy (RT), regardless the need of concomitant chemotherapy (RT-QT). Other studies focus the interest in the use of prophylactic exercises to prevent or minimize post-swallowing dysfunction.
Patients receiving RT or RT-QT refer worsening of their quality of life, especially during the first days after treatment. One study suggests that rehabilitation prior to cancer treatment could potentially improve quality of life. However, this observation should be contrasted with a randomized study.
研究の種類
介入
入学 (実際)
52
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Barcelona、スペイン、08024
- Hospital de l'Esperança
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients with advanced head and neck cancer receiving radiotherapy
Exclusion Criteria:
- Candidates to surgical treatment
- Previous head and neck cancer
- Dysphagia due to causes other than cancer
- Previous head or neck radiation therapy.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Early rehabilitation
Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months
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Early swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting 2 weeks before radiotherapy Expiratory/Inspiratory training: the training load is the maximum inspiratory/expiratory load defined according to patient tolerance. This load will be equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations (x 5 sessions), three times a day. All sessions will be conducted under the supervision of an expert physiotherapist/swallowing therapist. The total duration of the training program is 6 months. |
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アクティブコンパレータ：Later rehabilitation
Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy
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Late swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting after completing radiotherapy
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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 |
|---|---|---|
|
Change in dysphagia severity at three months post radiotherapy
時間枠：2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
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8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and >6, aspiration
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2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
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Change in quality of life at three months post radiotherapy
時間枠：2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
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Head & Neck Cancer 35 (HN35)
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2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
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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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Change in dysphagia security signs at three months post radiotherapy
時間枠：2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
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Security signs (tone of voice, coughing during or after eating, or desaturation of more than 3% compared to baseline pulse oximetry) assessed with the Volume Viscosity Swallow Test
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2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
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Change in lingual Force at three months post radiotherapy
時間枠：2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
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Lingual Force: maximum isometric tongue pressure of three peak isometric tongue pressure scores assessed with the IOPI system.
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2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年5月1日
一次修了 (実際)
2020年4月1日
研究の完了 (実際)
2020年5月1日
試験登録日
最初に提出
2016年2月15日
QC基準を満たした最初の提出物
2016年9月9日
最初の投稿 (見積もり)
2016年9月14日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月21日
QC基準を満たした最後の更新が送信されました
2020年9月18日
最終確認日
2020年9月1日
詳しくは
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