頭頸部放射線治療中のカスタマイズされた 3D プリント口腔ステント
カスタマイズされた 3D プリント口腔ステントを使用した場合と使用しない場合の頭頸部放射線治療のランダム化研究
This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving radiotherapy. Oral stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy. A customized, 3D-printed oral stent may help to reduce mouth blisters and/or sores that may develop in patients while receiving head and neck radiation therapy.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVE:
I. To evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.
SECONDARY OBJECTIVES:
I. To record patient reported outcomes during radiotherapy. II. To evaluate patient narcotic use during radiotherapy. III. To evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3D printed oral stent.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients wear 3D printed oral stent during standard of care radiotherapy.
ARM II: Patients receive standard of care during treatment.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85234
- Banner Health/Banner Research
-
-
Florida
-
Jacksonville、Florida、アメリカ、32207
- Baptist MD Anderson Cancer Center
-
-
Indiana
-
Indianapolis、Indiana、アメリカ、46219
- Community MD Anderson Cancer Center East
-
Indianapolis、Indiana、アメリカ、46227
- Community MD Anderson Cancer Center South
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Indianapolis、Indiana、アメリカ、46250
- Community MD Anderson Cancer Center North
-
-
New Jersey
-
Camden、New Jersey、アメリカ、08103
- Cooper Hospital University Medical Center
-
-
Texas
-
Houston、Texas、アメリカ、77030
- M D Anderson Cancer Center
-
-
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 Criteria:
- Participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy
- Age 18 or older
- ECOG PS 0-2
- The participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s)
- Signed study-specific consent form
Exclusion Criteria:
- Prior head and neck radiotherapy
- Participants is unable to fit a tongue-lateralizing or tongue-depressing stent
- Severe trismus with an incisal opening of <10 mm
- Inability to comply with the study procedures
- Participants younger than 18 years of age
- Participants must not be pregnant
- Cognitively impaired subjects
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：処理
- 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 (3D printed oral stent)
Patients wear 3D printed oral stent during standard of care radiotherapy. |
Receive standard of care
他の名前：
Wear 3D printed oral stent |
|
アクティブコンパレータ：Arm II (standard of care)
Patients receive standard of care during treatment. |
Receive standard of care
他の名前：
Wear 3D printed oral stent |
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 |
|---|---|---|
|
Mucositis toxicity rates
時間枠：Through study completion, an average of 1 year
|
Rate of non-target mucose will be estimated along with the corresponding 95% confidence interval. Cochran-Mantel-Haenszel (CHM) test will be applied to compare mucositis rates between the two treatment arms. Logistic regression will be used to compare occurrence of mucositis between two arms, adjusting for the effects of stratification factors as well as other covariates. T test or Wilcoxon rank sum test will be used to compare three Olerud-Molander Ankle Score between two arms: a mean mucositis score, an extent of mucositis score, and a worst site score. |
Through study completion, an average of 1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient reported outcomes
時間枠：Through study completion, an average of 1 year
|
Will be assessed using the MD Anderson Symptom Inventory Head and Neck questionnaire. T test or Wilcoxon rank sum test will be used to compare scores of each item per time point or sums of scores across all items at each time point or sums across three time point per item between the two arms. Multivariate analyses such as linear regression model adjusting for the effects of covariates might be performed to compare patients reported outcomes. Appropriate data transformation will be performed if necessary for assumption of normality. |
Through study completion, an average of 1 year
|
|
Patients narcotics diaries
時間枠：Through study completion, an average of 1 year
|
Will record the worst, the least, the average pain score and pain score at present for each day. Will calculate the average of these 4 scores as a composite daily pain score. |
Through study completion, an average of 1 year
|
|
Imaging difference
時間枠：Through study completion, an average of 1 year
|
The set up error during radiation will be measured in each treatment arm. |
Through study completion, an average of 1 year
|
|
Dosimetric difference
時間枠：Through study completion, an average of 1 year
|
The radiation dose to healthy tissue will be measured in each treatment arm. |
Through study completion, an average of 1 year
|
|
Composite pain scores
時間枠：Through study completion, an average of 1 year
|
An area under curve of pain scores over two weeks (AUC2wks) will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms. The linear mixed models will also be fitted to evaluate the association of composite pain scores with occurrence of their non-target mucosa. |
Through study completion, an average of 1 year
|
|
Number of narcotic pills used
時間枠：Through study completion, an average of 1 year
|
An AUC2wks will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms. |
Through study completion, an average of 1 year
|
協力者と研究者
捜査官
- 主任研究者：Anna Lee、M.D. Anderson Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2020-1153
- NCI-2021-03221 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- 2020-1153 (その他の識別子：M D Anderson Cancer Center)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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