Physical Activity Directly Before Immunotherapy (Nivolumab and Ipilimumab) in Melanoma (SPRINT)
SPRINT - Short Moderate Physical Regime INtervention Directly Before ImmunoTherapy for Melanoma
The aim of this research project is to determine whether a short bout of physical exercise immediately before the start of immunotherapy (Nivolumab and Ipilimumab) is feasible and has a positive effect on the effectiveness of immunotherapy. It is known that short-term physical exercise leads to marked changes in the innate and adaptive immune system. These changes-specifically an increase in natural killer (NK) cells and cytotoxic T cells-are associated with a better response to immunotherapy.
The patient population selected for this study consists of patients with advanced-stage melanoma who are receiving Nivolumab and Ipilimumab.
First, we aim to assess whether such an intervention is feasible in a large proportion of patients, as many patients experience disease-related and treatment-related side effects.
Secondary objectives are to demonstrate that the exercise intervention positively influences the immune system and that this, in turn, leads to an improved response to therapy, thereby positively affecting patient survival, improving quality of life, and reducing treatment-related side effects.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Joseph Tintelnot, MD
- Número de telefone: +49 040 7410 0
- E-mail: j.tintelnot@uke.de
Estude backup de contato
- Nome: Julian Kött, MD
- E-mail: j.koett@uke.de
Locais de estudo
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Free and Hanseatic City of Hamburg
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Hamburg, Free and Hanseatic City of Hamburg, Alemanha, 20251
- Recrutamento
- University Medical Center Hamburg-Eppendorf
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Contato:
- Julian Koett, MD
- Número de telefone: +49 40 7410 0
- E-mail: j.koett@uke.de
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Histologically confirmed metastatic malignant melanoma with an indication for immunotherapy (Nivolumab and Ipilimumab).
- The participant provides written informed consent for the study.
- The participant is at least 18 years of age on the day the informed consent is signed.
- No prior systemic anticancer therapy for metastatic disease (e.g., cytotoxic or targeted agents).
- ECOG (Eastern Cooperative Oncology Group) performance status score of ≤ 2.
- No physical impairment that would preclude participation in physical exercise.
Exclusion Criteria:
- Major surgery within 2 weeks prior to the start of the study intervention, or participants who have not fully recovered from the effects of a previous surgery.
- Participants with a diagnosed immunodeficiency, or those receiving chronic systemic corticosteroid therapy (at a dose greater than 10 mg prednisone equivalent per day), or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study medication.
- Participants with an active infection requiring systemic therapy.
- Participants with a known history of infection with human immunodeficiency virus (HIV) or hepatitis.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Control Arm
Treatment as standard of care
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Experimental: Sport
Before the start of therapy: Bicycle spiroergometry is performed to assess physical performance and to determine the anaerobic threshold, as well as to establish the heart rate range corresponding to an exertion level of 60-65% of maximal capacity. Prior to the first four immunotherapy infusions (administered every three weeks), patients perform moderate physical exercise on a cycle ergometer at 60-65% of maximal power output for 30 minutes. This exercise is performed immediately before the infusion. Exercise intensity is controlled using the heart rate range determined during the initial performance assessment. This intervention is repeated for a total of four times before the first 4 infusions of standard-of-care ICI. |
Moderate physical activity for 30 minutes on a cycle ergometer
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibility rate
Prazo: 9 weeks
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Rate of >70%
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9 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PFS
Prazo: Time from randomization to progression or death from any cause, up to 30 months.
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Median time is reported
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Time from randomization to progression or death from any cause, up to 30 months.
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Increase of NK cells and T cells or T cell subsets auch as CD103/CD39-positive CD8 T cells in the peripheral blood after cycling
Prazo: Difference calculated between blood draw directly before and directly after sport intervention.
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Difference calculated between blood draw directly before and directly after sport intervention.
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OS
Prazo: Time from randomization to progression or death from any cause, up to 30 months.
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Median OS is reported.
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Time from randomization to progression or death from any cause, up to 30 months.
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Increase of cytokines and chemokines, i.e. IL-15 after cycling
Prazo: Difference measured from the blood draw directly before and the blood draw directly after the sport intervention.
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Absolute concentrations
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Difference measured from the blood draw directly before and the blood draw directly after the sport intervention.
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Side effects
Prazo: Occurrence of side effects during active therapy with nivolumab and ipilimumab; the rate per patient is calculated from randomization to the end of the trial. Up to 30 months.
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Amount of patients and fraction experiencing AE and grade according to CTCAE v4.0 is reported.
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Occurrence of side effects during active therapy with nivolumab and ipilimumab; the rate per patient is calculated from randomization to the end of the trial. Up to 30 months.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
- Neoplasias por local
- Neoplasias
- Neoplasias por Tipo Histológico
- Doenças de pele
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Tumores Neuroendócrinos
- Nevos e Melanomas
- Neoplasias Cutâneas
- Comportamento
- Doenças da Pele e do Tecido Conjuntivo
- Melanoma
- Atividade motora
Outros números de identificação do estudo
- Version 1.0
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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