- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00214305
Effects of Swallowing Therapy in Head and Neck Cancer
연구 개요
상세 설명
Patients with head and neck cancer who are treated with chemoradiation and/or surgical resection may exhibit a variety of swallowing difficulties due to reduced range of motion (ROM) resulting from absence or alteration of the structures involved in deglutition. Chemoradiation protocols have been receiving increased attention in the treatment of head and neck cancer. The primary focus of these regimens is disease control and organ sparing. Preservation of oropharyngeal anatomy, however, has not equated with preservation of function. Due to the severity and frequency of swallowing problems in this population, it is critical that the effectiveness of dysphagia (i.e. swallowing disorder) rehabilitation protocols on preservation and/or restoration of function be determined. In the absence of potential remediation, patients may reject organ preservation treatment protocols because of negative functional side effects. There have been a number of therapeutic exercises designed to improve swallowing that have been shown to have a positive effect on head and neck cancer patients who are dysphagic as a result of treatment with surgery and/or chemoradiation. The short- and long-term effectiveness of these exercises has not been defined. The purpose of this study is to compare the effectiveness of combined ROM and postural sensory therapy for swallowing dysfunction to postural sensory therapy alone. By maximizing the effectiveness of therapy, it is expected that improved swallowing function will translate into better quality of life through enjoyment of meals and improved nutrition and hydration so critical to the health and sense of well being of individuals recovering from head and neck cancer.
To be included, subjects must be between 21 and 80 years old and have undergone treatment for the head and neck cancer in the form of chemoradiation, and/or one of the following specific types of head and neck cancer surgery: supraglottic laryngectomy, anterior resection with primary or skin graft closure, anterior resection with distal or free flap closure, posterior resection with primary or skin graft closure, or posterior resection with distal or free flap. Potential subjects must have been diagnosed with Stage I-IV disease and also be available for twice-weekly swallowing therapy sessions. Furthermore, subjects must be available for 12 months while on study.
No subject will be included who has any history of other medical problems that may affect swallowing, speech, voice, neurological problems, gastroenterological problems, or other health problems as determined by the patient's physician and the investigators. Patients with prior treated cancer of the head and neck, or who received a total laryngectomy operation are also not eligible.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- University of Wisconsin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subject have undergone treatment for the head and neck cancer in the form of chemoradiation, and/or one of the following specific types of head and neck cancer surgery: supraglottic laryngectomy, anterior resection with primary or skin graft closure, anterior resection with distal or free flap closure, posterior resection with primary or skin graft closure, or posterior resection with distal or free flap
- Potential subjects must have been diagnosed with Stage I-IV disease
Exclusion Criteria:
- history of medical problems that may affect swallowing, speech, voice
- neurological problems
- gastroenterological problems
- prior treatment for cancer of the head and neck
- patient who received a total laryngectomy
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 |
|---|---|
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실험적: Range of Motion Therapy Program
The program involves exercises and maneuvers that include voluntary maximal movements of the tongue, pitch range exercises, head lifting (Shaker exercise), resistance to laryngeal excursion (Mendelsohn Maneuver), breath holding after swallow and cough, thermal-tactile stimulation (ice), suck-swallow, optimal posturing, and dietary changes.
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The program involves exercises and maneuvers that include voluntary maximal movements of the tongue, pitch range exercises, head lifting (Shaker exercise), resistance to laryngeal excursion (Mendelsohn Maneuver), breath holding after swallow and cough, thermal-tactile stimulation (ice), suck-swallow, optimal posturing, and dietary changes.
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위약 비교기: Postural Sensory Therapy Program
The program involves all of the above, except that range of motion exercises (voluntary maximal movements of the tongue, pitch range exercises, head lifting, resistance to laryngeal excursion, breath holding after swallow and cough) are not performed.
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The program involves all of the above, except that range of motion exercises (voluntary maximal movements of the tongue, pitch range exercises, head lifting, resistance to laryngeal excursion, breath holding after swallow and cough) are not performed.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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improved swallowing function
기간: 1-month, 4-month, 6-month, and 12-month post treatment
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1-month, 4-month, 6-month, and 12-month post treatment
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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significantly more oral intake
기간: 1-month, 4-month, 6-month, and 12-month post treatment
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1-month, 4-month, 6-month, and 12-month post treatment
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a less restricted diet
기간: 1-month, 4-month, 6-month, and 12-month post treatment
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1-month, 4-month, 6-month, and 12-month post treatment
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less cost for medically needed services
기간: 1-month, 4-month, 6-month, and 12-month post treatment
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1-month, 4-month, 6-month, and 12-month post treatment
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Diane Bless, MD, University of Wisconsin, Madison
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .