두경부 방사선 치료 중 맞춤형 3D 인쇄 구강 스텐트
맞춤형 3D 프린팅 구강 스텐트 유무에 따른 두경부 방사선 요법의 무작위 연구
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85234
- Banner Health/Banner Research
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Florida
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Jacksonville, Florida, 미국, 32207
- Baptist MD Anderson Cancer Center
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Indiana
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Indianapolis, Indiana, 미국, 46219
- Community MD Anderson Cancer Center East
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Indianapolis, Indiana, 미국, 46227
- Community MD Anderson Cancer Center South
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Indianapolis, Indiana, 미국, 46250
- Community MD Anderson Cancer Center North
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New Jersey
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Camden, New Jersey, 미국, 08103
- Cooper Hospital University Medical Center
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Texas
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Houston, Texas, 미국, 77030
- M D Anderson Cancer Center
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm I (3D printed oral stent)
Patients wear 3D printed oral stent during standard of care radiotherapy. |
Receive standard of care
다른 이름들:
Wear 3D printed oral stent |
|
활성 비교기: Arm II (standard of care)
Patients receive standard of care during treatment. |
Receive standard of care
다른 이름들:
Wear 3D printed oral stent |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mucositis toxicity rates
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient reported outcomes
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Anna Lee, M.D. Anderson Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2020-1153
- NCI-2021-03221 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- 2020-1153 (기타 식별자: M D Anderson Cancer Center)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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