Effects of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck cancer patients undergoing chemotherapy or radiation therapy.
PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise therapy to see how well it works compared to late onset of swallowing exercise therapy in treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.
調査の概要
状態
条件
- 頭頸部がん
- I期喉頭がん
- II期喉頭がん
- Stage I Hypopharyngeal Cancer
- Stage I Oropharyngeal Cancer
- Stage II Hypopharyngeal Cancer
- Stage II Oropharyngeal Cancer
- Stage III Hypopharyngeal Cancer
- Stage III Laryngeal Cancer
- Stage III Oropharyngeal Cancer
- Stage IV Hypopharyngeal Cancer
- Stage IV Laryngeal Cancer
- Stage IV Oropharyngeal Cancer
詳細な説明
PRIMARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on swallowing quality of life in patients undergoing chemo/radiation therapy for head and neck cancer.
SECONDARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on swallowing function in patients undergoing radiation therapy for head and neck cancer.
TERTIARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on: individual domains of swallowing quality of life; Penetration Aspiration Scale (PAS) as assessed via FEES; diet level (Dysphagia Outcome and Severity Scale (DOSS) as assessed via FEES; feeding tube duration (days); Eating Assessment Tool (EAT); lingual strength as assessed via lingual manometry; and percent weight loss and percent weight recovery.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I (Early exercise group): Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
Arm II (Late exercise group): Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
In both arms, swallowing exercises are performed twice daily, 6 days a week, for 12 months following completion of radiotherapy.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
North Carolina
-
Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University Health Sciences
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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
説明
Inclusion
- Written informed consent must be obtained from all participants prior to beginning therapy (participants should have the ability to understand be willing to sign a written informed consent document)
- Individuals with oropharyngeal, hypopharyngeal, or laryngeal cancer of Stages I-IV undergoing radiation and chemo therapies at Wake Forest Baptist Medical Center
- Participants will have surgically received no more than selective neck dissection and tumor biopsy (participants who have undergone primary tumor resection or radical neck dissection will not be eligible)
- Participants must have completed a minimum of third grade education in order to answer questions of the quality of life survey
- Participants must be willing to participate in the swallowing exercise program
Exclusion
- Medical history of cerebrovascular accident, Parkinson's disease, any type of dementia, myasthenia gravis, or amyotrophic lateral sclerosis
- Previous radiation treatment for head/neck cancer
- Swallowing problem of etiology other than current lesion
- Pregnant women are not anticipated in the patient population, but would be excluded from participation in the study
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
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm I (Early exercise group)
Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
|
補助研究
他の名前：
補助研究
The early exercise group will start study exercises approximately two weeks prior to the onset of XRT.
The late exercise group will start study exercises one month after the completion of XRT.
Participants will undergo an initial/pre-radiation and 1-, 3-, 6-, and 12 month post-radiation swallowing assessments.
|
|
実験的：Arm II (Late exercise group)
Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
|
補助研究
他の名前：
補助研究
The early exercise group will start study exercises approximately two weeks prior to the onset of XRT.
The late exercise group will start study exercises one month after the completion of XRT.
Participants will undergo an initial/pre-radiation and 1-, 3-, 6-, and 12 month post-radiation swallowing assessments.
|
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 |
時間枠 |
|---|---|
|
M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
時間枠：Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
|
Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Penetration Aspiration Scale (PAS) as assessed via FEES
時間枠：Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
|
Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES
時間枠：Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
|
Feeding tube duration (days)
時間枠：Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
|
Eating Assessment Tool (EAT) quality of life score
時間枠：Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
|
Lingual strength as assessed by lingual manometry
時間枠：Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
|
Percent weight loss
時間枠：Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
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Percent weight recovery
時間枠：Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
協力者と研究者
捜査官
- 主任研究者：Susan Butler、Wake Forest University Health Sciences
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 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。