Exercise to Improve Outcomes in Pancreatic Cancer (ExO-PanC)
Exercise-Based Pre-, Peri- and Post-Surgery Intervention to Improve Clinical and Translational Outcomes in Patients Undergoing Whipple's Procedure: A Feasibility Study.
Pancreatic cancer surgery (Whipple's procedure) is a major operation that can lead to reduced physical fitness, delayed recovery, and difficulty starting chemotherapy after surgery. Exercise before and after surgery may help improve recovery, but it is not known whether a personalised exercise programme delivered throughout the surgical pathway is practical or acceptable for patients.
The Exercise to Improve Outcomes in Pancreatic Cancer (ExO-PanC) study is a single-arm feasibility study that will recruit adults with suspected pancreatic ductal adenocarcinoma who are scheduled to undergo Whipple's procedure. Participants will receive an individualised exercise programme before surgery, during their hospital stay, and after discharge until the start of adjuvant chemotherapy. The programme will include aerobic exercise and resistance training prescribed according to each participant's fitness level.
The primary objective is to determine whether this exercise programme is feasible by assessing recruitment, participant adherence, compliance with the prescribed exercise programme, and retention. Secondary exploratory objectives include evaluating surgical complications, initiation of adjuvant chemotherapy, physical fitness, quality of life, nutritional status, and blood, stool, and tumour biomarkers associated with clinical outcomes. Findings from this feasibility study will inform the design of a future multicentre randomised controlled trial evaluating the effectiveness of the ExO-PanC programme.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Pancreatic ductal adenocarcinoma (PDAC) is associated with poor survival, reduced physical function, and a high burden of treatment-related morbidity. Patients undergoing pancreaticoduodenectomy (Whipple's procedure) often experience substantial declines in cardiorespiratory fitness and muscle function before and after surgery, which may contribute to postoperative complications, delayed recovery, and reduced likelihood of receiving adjuvant chemotherapy. While prehabilitation programmes are increasingly incorporated into routine care, current approaches are not typically individualised using objective measures of physical fitness and generally do not extend across the entire perioperative pathway.
The Exercise to Improve Outcomes in Pancreatic Cancer (ExO-PanC) study has been developed to evaluate the feasibility of a personalised exercise programme delivered before surgery, during hospital admission, and throughout postoperative recovery until the commencement of adjuvant chemotherapy. Exercise prescriptions will be individualised using cardiopulmonary exercise testing (CPET), muscle strength assessments, and functional performance measures, allowing exercise intensity and progression to be tailored to each participant's physiological capacity.
Participants will undergo repeated assessments of cardiorespiratory fitness, physical function, muscle strength, nutritional status, quality of life, and biological sampling throughout the study. Blood, stool, and surgically resected tumour tissue will be collected to explore biomarkers associated with clinical outcomes and responses to exercise.
The primary objective of this feasibility study is to determine whether the ExO-PanC intervention can be successfully delivered across the perioperative pathway by evaluating participant recruitment, adherence, compliance with prescribed exercise, and study retention. Exploratory analyses will investigate surgical complications, initiation of adjuvant chemotherapy, changes in physical fitness and quality of life, and relationships between biological markers and clinical outcomes.
Results from this study will establish the feasibility of implementing a personalised perioperative exercise programme for patients undergoing pancreatic cancer surgery and will provide essential data to inform the design of a future adequately powered multicentre randomised controlled trial evaluating the effectiveness of the ExO-PanC intervention.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Tarak AM Chouari, BSc (Hons) MBChB
- Número de telefone: 01483688691
- E-mail: t.chouari@nhs.net
Locais de estudo
-
-
Surrey
-
Guildford, Surrey, Reino Unido, GU27XH
- Recrutamento
- University of Surrey
-
Contato:
- Tarak AM Chouari, BSc(Hons) MBChB
- Número de telefone: 01483688691
- E-mail: t.chouari@nhs.net
-
Subinvestigador:
- Tarak AM Chouari, BSc(Hons) MBChB
-
Investigador principal:
- Adam E Frampton, PhD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults aged 18 years or older.
- Planned to undergo upfront pancreatoduodenectomy (Whipple's procedure) for a suspected malignant periampullary mass.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- <18 years age
- Cardiopulmonary exercise test (CPET) contraindications
- Physical inability to perform CPET or undertake the program.
- Lacking the capacity to consent
- Unable to understand instructions in English
- Not scheduled for surgery
- A new diagnosis of Type 1 or Type 3c diabetes requiring management with insulin prescription will be excluded from the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention group
Participants will receive the ExO-PanC personalised exercise programme in addition to standard perioperative care.
The intervention comprises four phases spanning the surgical pathway: prehabilitation before surgery, supervised inpatient exercise following surgery, structured home-based recovery after hospital discharge, and rehabilitation before commencement of adjuvant chemotherapy.
Exercise is individually prescribed using cardiopulmonary exercise testing (CPET), muscle strength, and functional assessments, and includes aerobic and resistance with progression tailored to each participant's physical capacity.
Participants also undergo repeated assessments of physical fitness, quality of life, nutritional status, and collection of blood, stool, and tumour tissue samples throughout the study.
|
Participants will receive the ExO-PanC personalised exercise programme alongside standard perioperative care.
The intervention comprises four phases delivered across the surgical pathway: (1) prehabilitation before surgery, (2) supervised exercise during postoperative hospital admission, (3) structured home-based recovery following hospital discharge, and (4) rehabilitation before the commencement of adjuvant chemotherapy.
Exercise prescriptions are individualised using cardiopulmonary exercise testing (CPET), muscle strength, and functional assessments.
The programme includes aerobic, resistance, flexibility, and home-based exercise, with intensity and progression tailored to each participant's fitness level.
Exercise may be delivered in supervised or semi-supervised formats, with heart rate monitoring used to support exercise prescription and progression.
Participants continue to receive all standard NHS perioperative care throughout the study.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of the ExO-PanC exercise programme
Prazo: From enrolment until completion of the intervention (approximately 16-24 weeks)
|
Feasibility will be assessed using participant recruitment, adherence to the prescribed exercise programme (target >85% of prescribed sessions completed), compliance with prescribed exercise intensity, duration and type (target >80%), and participant retention (target <20% withdrawal for non-clinical reasons).
Feasibility will be evaluated separately across the preoperative, perioperative and postoperative phases of the intervention.
|
From enrolment until completion of the intervention (approximately 16-24 weeks)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative surgical complications
Prazo: Up to approximately 6 weeks following surgery.
|
Occurrence and severity of postoperative complications, including pancreatic fistula and other clinically relevant surgical complications
|
Up to approximately 6 weeks following surgery.
|
|
Commencement and completion of adjuvant chemotherapy
Prazo: From surgery until planned commencement and completion of adjuvant chemotherapy.
|
Proportion of participants who commence planned adjuvant chemotherapy following pancreaticoduodenectomy and proportion who complete it
|
From surgery until planned commencement and completion of adjuvant chemotherapy.
|
|
Cardiorespiratory fitness (CRF) measured by cardiopulmonary excercise testing (CPET)
Prazo: Baseline through completion of the intervention (approximately 16-24 weeks)
|
Difference in anaerobic threshold (mL/kg/min) and peak oxygen uptake (VO₂peak, mL/kg/min) measured during CPET.
|
Baseline through completion of the intervention (approximately 16-24 weeks)
|
|
Muscle strength
Prazo: Baseline through completion of the intervention (approximately 16-24 weeks).
|
Changes in upper and lower body muscle strength measured using standardised strength assessments.
|
Baseline through completion of the intervention (approximately 16-24 weeks).
|
|
Change in health-related quality of life measured using the EORTC QLQ-C30
Prazo: Serial measurements from baseline through completion of the intervention (approximately 16-24 weeks).
|
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Change in EORTC QLQ-C30 global health status, functional scales and symptom scales.
Scores range from 0-100.
|
Serial measurements from baseline through completion of the intervention (approximately 16-24 weeks).
|
|
Nutritional status
Prazo: Baseline through completion of the intervention (approximately 16-24 weeks).
|
Nutritional status assessed using the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF).
|
Baseline through completion of the intervention (approximately 16-24 weeks).
|
|
Change in pancreatic cancer-specific quality of life measured using the EORTC QLQ-PAN26
Prazo: This will be measured at five timepoints from recruitment through to commencement of adjuvant chemotherapy
|
Serial changes in EORTC QLQ-PAN26 symptom scores.
Scores range from 0-100.
|
This will be measured at five timepoints from recruitment through to commencement of adjuvant chemotherapy
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Adam E Frampton, PhD, University of Surrey
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
Outros números de identificação do estudo
- 350182
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 .