- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02217033
Effects of 'R' (Electro-kinetic Beverage) on Insomnia, Fatigue, and Depression in Breast Cancer Patients Having Adjuvant Chemo
A Pilot Study Evaluating the Effect of 'R' (Electro-Kinetically Altered Beverage) on Insomnia, Fatigue and Depression in Breast Cancer Patients Receiving Adjuvant Chemotherapy
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Female breast cancer patients eligible for adjuvant therapy with four cycles of Taxotere and Cytoxan chemotherapy after surgery will be enrolled for the study.
Eligible subjects will begin to consume either "R" or purified water (placebo) just prior to the 1st cycle of chemotherapy. Subjects will continue to consume either "R" or placebo through Cycle 1, Cycle 2, Cycle 3, Cycle 4, and for an additional 12 weeks after completing chemotherapy.
Study procedures will include clinical lab assessments, analysis of inflammatory markers, RNA biomarkers, adverse events, subject diary, and quality of life measurements for insomnia, fatigue and depression.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Washington
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Bonney Lake, Washington, Estados Unidos, 98391
- NWMS Bonney Lake - Medical Oncology
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Federal Way, Washington, Estados Unidos, 98003
- NWMS Federal Way - Medical Oncology
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Gig Harbor, Washington, Estados Unidos, 98332
- NWMS Gig Harbor - Medical Oncology
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Lakewood, Washington, Estados Unidos, 98499
- NWMS Lakewood - Medical Oncology
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Puyallup, Washington, Estados Unidos, 98373
- Rainier Hematology-Oncology, WA
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Tacoma, Washington, Estados Unidos, 98405
- NWMS Tacoma - Medical Oncology & Infectious Diseases
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Female, non-smokers ≥ 18 years of age
- Histologically or cytologically confirmed diagnosis of Stage I or II adenocarcinoma of the breast and a candidate for adjuvant chemotherapy
- Scheduled to receive 4 cycles of adjuvant Taxotere and Cytoxan chemotherapy (TC): docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on Day 1 of each 21-day cycle
- Eastern Cooperative Oncology Group Status (ECOG) performance status of ≤ 1
- No prior treatment for breast cancer other than surgery
Adequate baseline organ function as evidenced by:
- Hemoglobin ≥ 9 g/dL
- Absolute neutrophil count ≥ 1.5 x 109 cells/mm3
- Platelet count ≥ 100,000 cells/mm3
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
- Alkaline phosphatase ≤ 1.5 x ULN
- No history of other malignancies within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma or squamous cell carcinoma of the skin that have been previously treated with curative intent
- Women of childbearing potential who commit to using two forms of highly effective non-hormonal contraception either by the subject and/or partner during the study
- Negative urine pregnancy test at screening
- Negative urine drug screen (UDS) for drugs of abuse including cotinine (nicotine) at screening
- Subjects must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent
Exclusion Criteria:
- Preexisting diagnosed psychiatric disorder as defined by The Diagnostic and Statistical Manual (DSM) of Mental Disorders (published by the American Psychiatric Association). Subjects with a diagnosis of depression will be allowed to enter into study as long as they have been treated with medication for ≥ 6 months and/or depression is considered to be well controlled
- Pregnant or lactating
- Diabetes
- Concomitant use of any sleeping agents during the course of the study (Anti- anxiety medications will be allowed)
Steroid therapy other than the standard prescribed therapy of either of the following during the course of the study:
- Dexamethasone 4-12 mg IV on Day 1 of any cycle
- Dexamethasone 4-12 mg PO on Day 2 and Day 3 of any cycle
Anti-estrogen therapy other than the standard prescribed therapy of one of the following:
- Tamoxifen/Nolvadex 20 mg PO daily
- Anastrazole/Arimidex 1 mg PO daily
- Letrozole/Femara 2.5 mg PO daily
- Exemestane/Aromasin 25 mg PO daily
Use of any other antiemetic regimen other than the following (with the exception of PO antiemetics):
- Emend /Aprepitant150 mg IV on Day 1 of any cycle
- Aloxi/Palonosetron 0.25 mg IV on Day 1 of any cycle
- Dexamethasone 8 mg IV on Day 1 of any cycle
- Dexamethasone 8 mg PO on Day 2 and Day 3 of any cycle
- Zofran/Ondansetron 12 mg IV on Day 1 of any cycle
- Kytrile/Granisetron 1-2 mg IV on Day 1 of any cycle
- Therapy with any immunomodulatory or immunosuppressive drugs within 6 months prior to enrollment
- Known history of positive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and Hepatitis C antibody
- Any change in the initially prescribed chemotherapy
- Use of herbal remedies, dietary supplements or mega-vitamins, with the exception of a multi-vitamin
- Investigator deems the subject to be unable or unwilling to comply with the requirements of the protocol
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador de Placebo: Purified Water
In this arm, eligible subjects will begin to consume purified water (placebo) just prior to the 1st cycle of chemotherapy. Subjects will continue to consume the placebo through their chemotherapy and then for an additional 12 weeks after completing chemotherapy. Subjects will consume a specific volume based on the following weight categories: <150 lb = 2 bottles/day; ≥150 lb and <225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume placebo for a minimum of 168 days. |
|
Experimental: 'R' (Electro-kinetically altered beverage)
Patients randomized to this arm will begin to consume "R" (Electro-kinetically altered beverage) just prior to the 1st cycle of chemotherapy and continue it through their chemotherapy cycles and then for an additional 12 weeks after completing chemotherapy. Subjects will consume a specific volume based on the following weight categories: <150 lb = 2 bottles/day; ≥150 lb and <225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume R for a minimum of 168 days. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The effects of consuming "R" on quality of life in the areas of insomnia in breast cancer patients receiving multi-cycle adjuvant chemotherapy
Prazo: Patients will be followed for up to 25 weeks
|
SleepMed Insomnia Questionnaire: This is a test to assess, in general, how a subject is feeling about their sleep using a "0-4" point scale - with the "0" representing no problem with sleep and "4" representing a big problem with how a subject feels about the quality of their sleep.
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Patients will be followed for up to 25 weeks
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The effects of consuming "R" on quality of life in the areas of fatigue in breast cancer patients receiving multi-cycle adjuvant chemotherapy
Prazo: Patients will be followed for up to 25 weeks
|
FACIT Fatigue Scale: A list of questions that asks a patient how fatigued they have felt in the last 7 days.
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Patients will be followed for up to 25 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The effects of consuming "R" on quality of life in the areas of depression in breast cancer patients receiving multi-cycle adjuvant chemotherapy
Prazo: Patients will be followed for up to 25 weeks
|
Beck Depression Inventory-II: A list of statements that ask a subject about the way they have been feeling for the last two weeks.
|
Patients will be followed for up to 25 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Francis (Frank) Senecal, MD, Northwest Medical Specialties
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Sintomas Comportamentais
- Transtornos Mentais, Desordem Mental
- Doenças do Sistema Nervoso
- Doenças de pele
- Neoplasias
- Distúrbios do Sono Intrínsecos
- Dissônias
- Distúrbios do Sono Vigília
- Neoplasias por local
- Doenças da mama
- Depressão
- Neoplasias da Mama
- Fadiga
- Distúrbios de Iniciação e Manutenção do Sono
Outros números de identificação do estudo
- R822662
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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