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Reducing Cancer Side-effects With Systematic Light Exposure (LYS)

9 de fevereiro de 2021 atualizado por: Ali Amidi, Aarhus University Hospital
The main purpose of this interdisciplinary proposal is to conduct two randomized controlled trial (RCT) of the efficacy of self-administered systematic light exposure (Bright White Light (BWL)), an innovative, low cost, and low burden intervention to treat cancer-related fatigue. Another common and often overlapping treatment side-effect is cognitive impairment. A secondary outcome of the proposed RCT is, thus, cognitive functioning. Finally, possible underlying chronobiological (circadian activity rhythms, sleep), biological (pro inflammatory markers), and neurophysiological (brain morphology) mechanisms of BWL will be explored.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Two independent but similar RCTs with a total of 144 breast cancer patients (Group 1 = 72 high risk patients; Group 2 = 72 low risk breast cancer patients) post-treatment screened for fatigue will be randomized to BWL (36 in each of the two groups) or dim light(DL) (36 in each of the two groups) exposure for 30 minutes/morning for 4 weeks, and assessed before, during, immediately and 3 months after the intervention. Measures include questionnaires, cognitive assessment, actigraphy, blood samples, saliva samples, and magnetic resonance imaging (MRI).

1.1 Aims and hypotheses. Aim 1: To test the efficacy of BWL on fatigue (primary outcome) in breast cancer patients.

Hypothesis 1: Compared with control participants exposed to DL, participants randomized to BWL will report less fatigue immediately and 3 months after the intervention.

Aim 2: To test the efficacy of BWL on cognitive functioning (secondary outcome).

Hypothesis 2: Compared with controls, BWL recipients will show improved cognitive functioning immediately and 3 months after the intervention.

Aim 3: To explore the effects of BWL on chronobiological, biological, and neurophysiological markers.

Hypothesis 3: BWL will be associated with normalized circadian activity rhythms (3a); improved sleep (3b); decreased inflammation (3c); increased cortical and subcortical grey matter density (3d); and increased cortical and subcortical white matter integrity (3e). If hypotheses 1 and/or 2 are confirmed, the mediating effects of the markers will be explored.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

72

Estágio

  • Não aplicável

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.

Contato de estudo

  • Nome: Ali Amidi, Ph.D.
  • Número de telefone: +4587165305
  • E-mail: ali@psy.au.dk

Locais de estudo

  • Dinamarca
      • Aarhus, Dinamarca, 8000
        • Recrutamento
        • Aarhus Universitets Hospital
        • Contato:
          • Birgitte Offersen, PhD, MD

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

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

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria - Group 1:

  • High-risk breast cancer patients as defined by the Danish Breast Cancer Cooperative Group (DBCG) having received treatment according to the DBCG guidelines
  • Minimum age of 18 years; completion of adjuvant whole breast radiation treatments
  • A score <34 on the FACIT-Fatigue scale (see below) after radiotherapy
  • Availability for home-based 4-week BWL/DL-treatment.

Exclusion Criteria:

  • History of chronic fatigue disorders
  • Pregnancy
  • Confounding underlying medical illnesses such as significant pre-existing anemia
  • Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment)
  • History of bipolar disease or mania (which are contra-indications for light treatment)
  • Current clinical depression
  • History of seasonal affective disorder
  • Previous diagnosis of sleep apnea, restless legs or other sleep disorders (not including insomnia) known to affect fatigue
  • Employment in shift work
  • Chronic use of oral steroid medication
  • Prior use of light treatment
  • Use of photosensitising medications
  • Plans to travel across meridians
  • Insufficient Danish language proficiency

Inclusion criteria - Group 2:

  • Low-risk postmenopausal patients as defined by the DBCG having received breast-conserving surgery for lymph node-negative breast cancer
  • Completion of adjuvant whole breast radiation treatments
  • A score <34 on the FACIT Fatigue scale (see below) after radiotherapy
  • Availability for home-based 4-week BWL/DL-treatment.

Exclusion Criteria:

  • History of chronic fatigue disorders
  • Pregnancy
  • Confounding underlying medical illnesses such as significant pre-existing anemia
  • Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment)
  • History of bipolar disease or mania (which are contra-indications for light treatment)
  • Current clinical depression
  • History of seasonal affective disorder
  • Previous diagnosis of sleep apnea, restless legs or other sleep disorders (not including insomnia) known to affect fatigue
  • Employment in shift work
  • Chronic use of oral steroid medication
  • Prior use of light treatment
  • Use of photosensitising medications
  • Plans to travel across meridians
  • Insufficient Danish language proficiency

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: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Systematic bright light exposure
Systematic bright light exposure for 30 min. for 4 weeks
Dispositivo: Litebook
Comparador Ativo: Systematic dim light exposure
Systematic dim light exposure for 30 min. for 4 weeks
Dispositivo: Litebook

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Cancer-related fatigue (FACIT-fatigue)
Prazo: Changes in fatigue from baseline to immediately after intervention (T1-T2)
Changes in fatigue from baseline to immediately after intervention (T1-T2)
Cancer-related fatigue (FACIT-fatigue)
Prazo: Changes in fatigue from baseline to 3 months after intervention
Changes in fatigue from baseline to 3 months after intervention

Medidas de resultados secundários

Medida de resultado
Prazo
Pittsburgh Sleep Quality Index (PSQI)
Prazo: Immediately after intervention and 3 months after intervention
Immediately after intervention and 3 months after intervention
Beck's Depression Inventory - II (BDI-II)
Prazo: Immediately after intervention and 3 months after intervention
Immediately after intervention and 3 months after intervention
Connors Continous performance test (CPT-3)
Prazo: Immediately after intervention
Immediately after intervention
Psychomotor vigilance test (PVT)
Prazo: Immediately after intervention
Immediately after intervention
Hopkins Verbal Learning Test (HVLT-R)
Prazo: Immediately after intervention
Immediately after intervention
Health-related quality of life (SF-36)
Prazo: Immediately after intervention and 3 months after intervention
Immediately after intervention and 3 months after intervention
Anxiety symptoms (HADS Anxiety)
Prazo: Immediately after intervention and 3 months after intervention
Immediately after intervention and 3 months after intervention
Impact of events (IES-R)
Prazo: Immediately after intervention and 3 months after intervention
Immediately after intervention and 3 months after intervention
Patients assessment of own functioning Inventory (POAFI)
Prazo: Immediately after intervention and 3 months after intervention
Immediately after intervention and 3 months after intervention
Overall neuropsychological composite score
Prazo: Immediately after intervention and 3 months after intervention
Immediately after intervention and 3 months after intervention

Outras medidas de resultado

Medida de resultado
Prazo
Mediators: Changes in brain white mater diffusion integrity as measured with diffusion-weighted MR imaging: Diffusion/kurtosis parameters.
Prazo: Immediately after intervention
Immediately after intervention
Mediators: Changes in Pro-inflammatory cytokines (Il-1, Il-6, Tnf-alpha) (blood draw)
Prazo: Changes from baseline to immediately after intervention
Changes from baseline to immediately after intervention
Mediators: Changes in circadian activity rhythms (actigraphy)
Prazo: Changes from baseline to immediately after intervention
Changes from baseline to immediately after intervention
Mediators: Changes in diurnal Cortisol (saliva samples)
Prazo: From baseline to immediately after intervention
From baseline to immediately after intervention
Mediators: Changes in diurnal melatonin (as measured with saliva samples)
Prazo: From baseline to immediately after intervention
From baseline to immediately after intervention
Mediators: Changes in grey matter density as measured by T-1 weighted MR imaging (voxel-based morphometry)
Prazo: Immediately after intervention
Immediately after intervention

Colaboradores e Investigadores

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

Patrocinador

Aarhus University Hospital

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 (Real)

1 de março de 2016

Conclusão Primária (Antecipado)

1 de agosto de 2021

Conclusão do estudo (Antecipado)

1 de dezembro de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

15 de dezembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de janeiro de 2016

Primeira postagem (Estimativa)

22 de janeiro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de fevereiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de fevereiro de 2021

Última verificação

1 de fevereiro de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Sagsnr. 1-10-72-286-15

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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