Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors
Feasibility and Immunometabolic Effects of Intermittent Fasting During Immune Checkpoint Inhibitor Therapy: A Randomized Pilot Study in Advanced Solid Tumors
This single-site, randomized pilot study will evaluate whether intermittent fasting is feasible and safe for patients with advanced solid tumors who are starting immune checkpoint inhibitor (ICI) therapy at the WVU Cancer Institute. Participants will be assigned to 1 of 3 groups: usual care with no fasting, alternate-day fasting (ADF), or time-restricted eating (TRE).
Participants in the ADF group will follow cycles of 12 hours of eating followed by 36 hours of fasting every other day. Participants in the TRE group will eat all daily calories within an 8-hour window each day. The fasting intervention will begin within 1 week of starting ICI treatment and continue for approximately 20-24 weeks during 8 cycles of therapy.
The study will evaluate adherence to the fasting regimens and compare side effects between groups. Researchers will also study changes in metabolic and immune biomarkers, fatigue, sleep, and quality of life. Participants will be followed for 30 days after completion of the intervention to monitor safety and tolerability.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Meg Zafiris
- Número de telefone: 304-293-6065
- E-mail: margaret.zafiris@hsc.wvu.edu
Estude backup de contato
- Nome: Joni Aldinger
- Número de telefone: 304-293-5949
- E-mail: jlaldinger@hsc.wvu.edu
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Diagnosis of advanced esophageal, gastric, non-small cell lung cancer (NSCLC), HCC, cholangiocarcinoma, melanoma, RCC, or MSI-H cancer
- Planned treatment with ICI-based therapy
- ECOG 0-2
- Ability to provide informed consent
- Willingness to follow dietary guidance and record adherence
- BMI = 23-40
Exclusion Criteria:
Diabetes requiring insulin
- Active eating disorders
- Sarcopenia and/or cachexia (mild, moderate, severe), including sarcopenic obesity
- A history of hypoglycemia, including idiopathic and postbariatric hypoglycemia
- Patients taking sulfonylureas (concern for hypoglycemia with fasting)
- Night shift workers (at discretion of investigator)
- >10% weight loss within the past 3 months through self-reporting or chart review.
- Any uncontrolled autoimmune condition or recent high-dose steroid use
- Severe GI or endocrine disorders precluding fasting including but not limited to malabsorption syndromes, gastroparesis, or Addison's/Cushing's
- Pregnant or breastfeeding
Plano de estudo
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 |
|---|---|
|
Sem intervenção: Usual Care, No Fasting
Participants will receive standard nutrition education materials per institutional practice.
No fasting regimen will be prescribed during immune checkpoint inhibitor (ICI) therapy.
|
|
|
Experimental: Alternate-Day Fasting (ADF)
Participants will follow a repeating cycle of approximately 12 hours of eating followed by 36 hours of fasting every other day during ICI therapy.
During fasting periods, participants may consume plain coffee, sugar-free tea, sugar-free herbal tea, sugar-free chewing gum, and 1-2 cups per day of clear vegetable or meat broth (up to 500 kcal/day).
The fasting intervention will begin within 1 week of ICI initiation and continue for 8 cycles of therapy (approximately 20-24 weeks).
|
Participants will follow an alternate-day fasting regimen during ICI therapy consisting of approximately 12 hours of eating followed by 36 hours of fasting every other day.
|
|
Experimental: Time-Restricted Eating (TRE)
Participants will consume all daily calories within an 8-hour eating window each day during ICI therapy, typically between 10:00 AM and 6:00 PM, with flexibility to shift the window by 1 hour earlier or later.
Outside the eating window, participants may consume plain coffee, tea, herbal tea, sugar-free chewing gum, and 1-2 cups per day of clear broth.
The fasting intervention will begin within 1 week of ICI initiation and continue for 8 cycles of therapy (approximately 20-24 weeks).
|
Participants will follow a time-restricted eating regimen during ICI therapy by consuming all daily calories within an 8-hour window each day, typically between 10:00 AM and 6:00 PM, with flexibility to shift the window by 1 hour earlier or later.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adherence to Assigned Intermittent Fasting Regimen
Prazo: Up to approximately 24 weeks (8 treatment cycles)
|
Adherence will be assessed using participant-completed fasting diaries. For the time-restricted eating (TRE) arm, adherence is defined as meeting the assigned fasting window on ≥5 days per week. For the alternate-day fasting (ADF) arm, adherence is defined as meeting fasting-day criteria on ≥5 days within each 14-day period. Adherence will be summarized as the proportion of participants who meet the assigned regimen-specific adherence criteria during the study period. |
Up to approximately 24 weeks (8 treatment cycles)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Adverse Events
Prazo: Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-up
|
Adverse events (AEs) and immune-related AEs (irAE) will be summarized and compared descriptively between study arms.
Events will be graded according to CTCAE.
The proportion of participants experiencing irAEs, including grade ≥3 irAEs, will be summarized by treatment group.
|
Up to approximately 24 weeks (8 treatment cycles) plus 30-day safety follow-up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nour Daboul, MD, West Virginia University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- Doenças urogenitais
- Neoplasias urogenitais
- Neoplasias por local
- Doenças Urogenitais Masculinas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Neoplasias por Tipo Histológico
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças do Fígado
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Neoplasias Hepáticas
- Doenças de pele
- Neoplasias Urológicas
- Carcinoma
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Neoplasias Renais
- Tumores Neuroendócrinos
- Nevos e Melanomas
- Neoplasias Cutâneas
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias
- Carcinoma Hepatocelular
- Carcinoma de Células Renais
- Colangiocarcinoma
- Melanoma
Outros números de identificação do estudo
- STUDY00000260
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .