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

28 de maio de 2017 atualizado por: 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.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

41

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232-6838
        • Vanderbilt-Ingram Cancer Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

21 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Arm IA
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Procedimento: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Comparador Ativo: Arm IB
Patients undergo SNT and low weight resistance training (LWRT).
Procedimento: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Comportamental: exercise intervention
Patients undergo low weight resistance training.
Experimental: 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.
Procedimento: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Medicamento: amifostine trihydrate
Given subcutaneously
Outros nomes:
  • Etiol
Experimental: 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.
Procedimento: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Comportamental: exercise intervention
Patients undergo low weight resistance training.
Medicamento: amifostine trihydrate
Given subcutaneously
Outros nomes:
  • Etiol

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Patients With Each Degree of Swallowing Dysfunction
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Stimulated and Unstimulated Salivary Production
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Vanderbilt-Ingram Cancer Center

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Cadeira de estudo: Barbara A. Murphy, MD, Vanderbilt-Ingram Cancer Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2006

Conclusão Primária (Real)

1 de agosto de 2008

Conclusão do estudo (Real)

1 de agosto de 2008

Datas de inscrição no estudo

Enviado pela primeira vez

17 de julho de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de julho de 2007

Primeira postagem (Estimativa)

19 de julho de 2007

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de junho de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de maio de 2017

Última verificação

1 de maio de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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