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Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia

2017년 5월 28일 업데이트: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer.

PURPOSE: This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

OBJECTIVES:

Primary

  • To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine

Secondary

  • To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
  • To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
  • To assess the effects of dysphagia, xerostomia, and mucositis-related inflammation on nutritional, physical, and functional status

OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy comprising carboplatin and paclitaxel weekly.

Patients are randomized to 1 of 2 treatment arms.

  • Arm I (standard of care): Patients are further divided into 1A or 1B.

    • Arm IA: Standard of care plus standardized nutrition therapy (SNT)
    • Arm IB: Standard of care plus standardized nutrition therapy plus low weight resistance training (LWRT).

  • Arm II (amifostine): Patients are further divided into 2A or 2B.

    • Arm IIA: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy
    • Arm IIB: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy plus low weight resistance training

In all arms, patients undergo swallowing function, dietary, body composition, muscle, and physical and functional performance measurements at baseline and at 1, 3, and 6 months post-therapy. Quality of life, salivary production, fatigue, and symptoms (including swallowing/eating foods, appetite, weight loss/nutrition, pain, and speech/communication) are assessed at baseline and at 1, 3, and 6 months post-therapy. Anthropometric measurements are also performed at the above time points and at mid-therapy.

Blood samples and buccal rinses are collected at baseline and at 1, 3, and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandem mass spectrometry.

After completion of study treatment, patients are followed at 1, 3, and 6 months.

연구 유형

중재적

등록 (실제)

41

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Tennessee
      • Nashville, Tennessee, 미국, 37232-6838
        • Vanderbilt-Ingram Cancer Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

21년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria

  • Age greater than 21
  • Biopsy proven stage 3 or 4 squamous cell carcinoma of the larynx, pharynx, oral cavity or salivary glands
  • No prior history of active cancer within three years other than non-melanoma skin cancer, early stage prostate or early stage cervical cancer
  • controlled co-morbid disease
  • ECOG PS of 0-3
  • Plan for definitive or post-operative CCR within 4 weeks
  • Written informed consent
  • Working telephone
  • May have received prior induction chemotherapy
  • Agree to use only study supplied liquid nutrition supplements or dietary supplements, for per os or feeding tube intake

Exclusion Criteria

  • Diagnosed HIV or AIDS
  • History of ETOH or drug abuse within 3 months
  • Pregnant or lactating
  • On steroid medication or prescribed NSAIDs
  • Consuming specialty nutrition supplements containing additional amounts of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA)
  • On orexigenic (appetite stimulant) medication.
  • Uncontrolled comorbid disease defined as: a) severe cardiac disease Class III or greater; b) blood pressure > 160/95; c) uncontrolled pain
  • Does not have working telephone.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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
활성 비교기: Arm IA
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
절차: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
활성 비교기: Arm IB
Patients undergo SNT and low weight resistance training (LWRT).
절차: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
행동: exercise intervention
Patients undergo low weight resistance training.
실험적: Arm IIA
Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
절차: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
의약품: amifostine trihydrate
Given subcutaneously
다른 이름들:
  • 에틸
실험적: Arm IIB
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
절차: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
행동: exercise intervention
Patients undergo low weight resistance training.
의약품: amifostine trihydrate
Given subcutaneously
다른 이름들:
  • 에틸

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Patients With Each Degree of Swallowing Dysfunction
기간: 6 months after concurrent chemotherapy and radiation
Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment
6 months after concurrent chemotherapy and radiation

2차 결과 측정

결과 측정
측정값 설명
기간
Stimulated and Unstimulated Salivary Production
기간: 6 months after concurrent chemotherapy and radiation
Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.
6 months after concurrent chemotherapy and radiation
Number of Patients With Oral Mucositis by Grade
기간: 6 months after concurrent chemotherapy and radiation
Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).
6 months after concurrent chemotherapy and radiation
Changes in the Amount and Texture of Food Consumed
기간: at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.
at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Changes in the Frequency and Types of Dietary Intakes
기간: at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.
at baseline, at 1 month, 3 months and 6 months post-chemoradiation

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Vanderbilt-Ingram Cancer Center

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Barbara A. Murphy, MD, Vanderbilt-Ingram Cancer Center

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2006년 1월 1일

기본 완료 (실제)

2008년 8월 1일

연구 완료 (실제)

2008년 8월 1일

연구 등록 날짜

최초 제출

2007년 7월 17일

QC 기준을 충족하는 최초 제출

2007년 7월 17일

처음 게시됨 (추정)

2007년 7월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 6월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 5월 28일

마지막으로 확인됨

2017년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • VICC HN 0554
  • VU-VICC-HN-0554
  • VU-VICC-IRB-051068

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. .

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