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.
연구 개요
상태
정황
- 두경부암
- 1기 후두암
- 2기 후두암
- 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
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest University Health Sciences
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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보조 연구
다른 이름들:
보조 연구
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.
|
|
실험적: Arm II (Late exercise group)
Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
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보조 연구
다른 이름들:
보조 연구
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
기간: Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
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Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Penetration Aspiration Scale (PAS) as assessed via FEES
기간: Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Baseline and at 1, 3, and 6 months following completion of radiotherapy
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|
Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES
기간: Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Feeding tube duration (days)
기간: Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Eating Assessment Tool (EAT) quality of life score
기간: Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Lingual strength as assessed by lingual manometry
기간: Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Percent weight loss
기간: Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Percent weight recovery
기간: Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Baseline and at 1, 3, and 6 months following completion of radiotherapy
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공동 작업자 및 조사자
수사관
- 수석 연구원: Susan Butler, Wake Forest University Health Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- IRB00010437
- NCI-2009-01445 (기타 식별자: CTRP)
- CCCWFU 98109 (기타 식별자: Wake Forest University Health Sciences)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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삶의 질 평가에 대한 임상 시험
-
Memorial Sloan Kettering Cancer Center종료됨
-
Karaman Training and Research Hospital완전한수술 후 합병증 | 척추외과 | 복구 품질 | 수술 후 진통제칠면조