- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00031707
Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) Versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement Versus Both for the Treatment of Cancer Cachexia and Anorexia
RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite.
PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Compare the appetite-stimulating properties of megestrol vs an eicosapentaenoic acid-enriched nutritional supplement vs both, in terms of patient weight, rate of weight change, and appetite, in patients with cancer-related cachexia and anorexia.
- Determine the effect of these regimens on nausea and vomiting in these patients.
- Assess quality of life in patients treated with these regimens.
- Determine the toxic effects of these regimens in these patients.
- Compare overall survival of patients treated with these regimens.
- Correlate interleukin-6 concentration changes with appetite and weight changes in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to primary cancer (lung vs gastrointestinal vs other), severity of weight loss in the past 2 months (less than 10 pounds vs 10 pounds or more), planned concurrent chemotherapy (yes vs no), age (under 50 vs 50 and over), and prognosis (good vs bad vs unsure). Patients are randomized to 1 of 3 treatment arms.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Alberta
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Calgary, Alberta, Canadá, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Kelowna, British Columbia, Canadá, V1Y 5L3
- British Columbia Cancer Agency - Centre for the Southern Interior
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Nanaimo, British Columbia, Canadá, V9S 2B7
- Nanaimo Cancer Clinic
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Vancouver, British Columbia, Canadá, V5Z 4E6
- British Columbia Cancer Agency
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0V9
- CancerCare Manitoba
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New Brunswick
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Saint John, New Brunswick, Canadá, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canadá, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
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Ontario
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Brampton, Ontario, Canadá, L6W 2Z8
- William Osler Health Centre
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Hamilton, Ontario, Canadá, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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Kingston, Ontario, Canadá, K7L 5P9
- Kingston Regional Cancer Centre
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London, Ontario, Canadá, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Mississauga, Ontario, Canadá, L5B 1B8
- Trillium Health Centre
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Ottawa, Ontario, Canadá, K1H 1C4
- Ottawa Regional Cancer Centre
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Peterborough, Ontario, Canadá, K9H 7B6
- Peterborough Oncology Clinic
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Toronto, Ontario, Canadá, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, Canadá, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canadá, C1A 8T5
- Queen Elizabeth Hospital, PEI
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Quebec
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Montreal, Quebec, Canadá, H2W 1S6
- McGill University
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Montreal, Quebec, Canadá, H1T 2M4
- Maisonneuve-Rosemont Hospital
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Ste-Foy, Quebec, Canadá, G1V 4G5
- L'Hopital Laval
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Saskatchewan
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Regina, Saskatchewan, Canadá, S4T 7T1
- Allan Blair Cancer Centre
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic
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Illinois
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Peoria, Illinois, Estados Unidos, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Estados Unidos, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Estados Unidos, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Estados Unidos, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Estados Unidos, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Estados Unidos, 67214-3882
- CCOP - Wichita
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- CCOP - Ochsner
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Ann Arbor Regional
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Estados Unidos, 56303
- CentraCare Health Plaza
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58501
- Medcenter One Health System
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - Merit Care Hospital
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Grand Forks, North Dakota, Estados Unidos, 58201
- Altru Health Systems
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Ohio
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Toledo, Ohio, Estados Unidos, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Pennsylvania
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Danville, Pennsylvania, Estados Unidos, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15212-4772
- Allegheny General Hospital
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Estados Unidos, 57104
- CCOP - Sioux Community Cancer Consortium
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Histologically or cytologically proven cancer other than brain, breast, ovarian, endometrial, or prostate cancer
- Compelling clinical evidence of cancer is allowed when tissue sample is unobtainable
- Considered incurable with available therapies
- At least 5 pounds weight loss within the past 2 months (excluding perioperative weight loss) and/or have estimated caloric intake of less than 20 cal/kg daily
- Weight loss must be perceived as a problem by the patient
- Potential weight gain must be considered beneficial by the attending physician
- No history of primary brain cancer or brain metastases
- No clinical evidence of ascites
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Cardiovascular:
- No poorly controlled congestive heart failure
- No poorly controlled hypertension
- No history of thromboembolic disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Alert and mentally competent
- Able to reliably take oral medication
- No known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (more than 5 episodes per week)
- No diabetes requiring insulin
- Diabetes requiring an oral hypoglycemic agent or diet control allowed
PRIOR CONCURRENT THERAPY:
Chemotherapy:
- Concurrent chemotherapy allowed
Endocrine therapy:
- At least 1 month since prior adrenal steroids, androgens, progestational agents, or appetite stimulants (e.g., dronabinol)
No concurrent adrenal steroids, androgens, other progestational agents, or appetite stimulants (e.g., dronabinol)
- Inhalant, topical, or optical steroids allowed
- Short-term dexamethasone as an anti-emetic during chemotherapy allowed
Radiotherapy:
- Concurrent radiotherapy allowed
Other:
- No tube feedings or parenteral nutrition
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: megestrol + placebo
Patients receive oral megestrol once daily and oral placebo twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years. |
|
Comparador Ativo: eicosapentaenoic acid + placebo
Patients receive oral placebo once daily and an eicosapentaenoic acid (EPA)-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years. |
|
Experimental: megestrol + eicosapentaenoic acid
Patients receive oral megestrol once daily and an EPA-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite)
Prazo: Up to 5 years
|
Up to 5 years
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Sobrevida geral
Prazo: Até 5 anos
|
Até 5 anos
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Assess quality of life
Prazo: Up to 5 years
|
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Metabólicas
- Sinais e Sintomas Digestivos
- Distúrbios Nutricionais
- Peso corporal
- Alterações de Peso Corporal
- Emagrecimento
- Perda de peso
- Anorexia
- Síndrome de Desperdício
- Caquexia
- Efeitos Fisiológicos das Drogas
- Agentes Antineoplásicos
- Agentes Antineoplásicos Hormonais
- Agentes Contraceptivos Hormonais
- Anticoncepcionais
- Agentes de Controle Reprodutivo
- Anticoncepcionais Orais
- Agentes Contraceptivos, Feminino
- Anticoncepcionais Orais Sintéticos
- Anticoncepcionais, Orais, Hormonais
- Estimulantes do Sistema Nervoso Central
- Estimulantes de Apetite
- Megestrol
- Acetato de Megestrol
Outros números de identificação do estudo
- NCCTG-989255
- CDR0000069218 (Identificador de registro: PDQ (Physician Data Query))
- CAN-NCIC-SC18
- NCI-P02-0205
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 .