Prehabilitation of Patients With oEsophageal Malignancy Undergoing Peri-operative Treatment (Pre-EMPT)

G

Guy's and St Thomas' NHS Foundation Trust

Status

Unknown

Conditions

Chemotherapy Effect
Oesophageal Adenocarcinoma
Surgery

Treatments

Behavioral: Exercise prehabilitation during chemotherapy before surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03626610
IRAS 204711 Pre-EMPT PROTOCOL

Details and patient eligibility

About

'Pre-EMPT' - A cohort-controlled, interventional study to assess the effects of a pre-emptive exercise programme, or 'prehabilitation', in patients undergoing peri-operative chemotherapy for adenocarcinoma of the lower oesophagus and gastro-oesophageal junction.

Full description

Oesophageal cancer has the fastest rising incidence of any solid tumour in the western world with the UK, and London, having particularly high rates of the disease. Those patients being considered for "cure" will benefit from pre-operative/neo-adjuvant chemotherapy (NAC), which is known to have a deleterious effect on fitness and is associated with increased post-operative morbidity. Post-operative morbidity is also associated with reduced survival. Reduction in fitness is compounded by major surgery and significantly reduces the numbers of patients who commence or complete the standard treatment of post-operative chemotherapy to around 40%. Chemotherapy and surgery for oesophageal cancer both represent significant physiological insults that may have detrimental effects on physical activity and outcomes after surgery. Cardiopulmonary exercise (CPEX) testing has been effectively used in numerous tumour groups to predict outcome after surgery, although its role in oesophageal cancer patients remains uncertain owing to conflicting data from institutional series. Advanced exercise programmes, sometimes termed 'prehabilitation', directed by experienced multidisciplinary teams are increasingly being used to mitigate the secondary effects of cancer treatment. 'Prehabilitation' has been shown to reduce postoperative morbidity and mortality in thoracic patients undergoing elective high-risk surgery. In addition, results of studies examining physical exercise and cancer recurrence/survival which effect immune system function in cancer survivors suggest that physical exercise training may improve a number of immune system parameters that may be important in cancer defence. The investigators believe that optimising patient fitness through a structured and expert-devised exercise programme of 'prehabilitation' during neo-adjuvant chemotherapy and prior to surgery will mitigate the effects of chemotherapy and improve patient outcomes after surgery. The investigators intend to assess the feasibility of a 'prehabilitation' programme and quantify the resultant effects primarily using CPEX testing. In addition, changes in hospital 'length of stay' will be documented with a number of additional parameters.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must be diagnosed with operable oesophageal and gastro-oesophageal adenocarcinoma and scheduled to undergo standard neo-adjuvant chemotherapy and oesophago-gastric surgery as recommended by the Multidisciplinary Meeting decision.
  • 18+
  • </=79 (patients above this age may be included in studies after the feasibility study has been completed)
  • Participants must be able to understand and independently consent to participation in the study.
  • Participants must be able to understand and complete the questionnaires.
  • Participants must be willing to undergo all the standard assessments and interventions included in this study - CPEX testing, blood sampling, questionnaires and exercise intervention where appropriate.
  • Participants must be willing to wear the Fibit monitoring device and agree with its use
  • Participants must be ASA 1-3 and fit for surgical resection
  • Patients should have a Body Mass Index (BMI) equal to or above 18.5 with less than 10% self-reported unintentional weight loss at diagnosis.

Exclusion criteria

Participants will be excluded if they:

  • Are not considered medically fit for surgery at diagnosis, as decided by the Multidisciplinary team
  • Will undergo primary or palliative chemotherapy
  • Are recommended to have chemoradiotherapy
  • Are under 18 years old
  • Are over 79 years old
  • Are unable to undergo CPEX testing
  • Do not wish to take part in selected aspects of the study
  • Cannot or do not wish to attend the CHHP for assessment and/or advice on exercise
  • Cannot understand and give informed consent to the study
  • Cannot understand and complete the questionnaires
  • Do not wish to wear a Fitbit monitoring device
  • ASA 4+
  • Patients with BMI of less than 18.5 with self-reported unintentional weight loss of 10% or more at diagnosis.

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups

Interventional
Experimental group
Description:
Participants will be given a monitored exercise program during their treatment starting before chemotherapy
Treatment:
Behavioral: Exercise prehabilitation during chemotherapy before surgery
Non-interventional
No Intervention group
Description:
Patients will have standard care.

Trial contacts and locations

1

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Central trial contact

Janine Zylstra; Andrew Davies, MBChBMDFRCS

Data sourced from clinicaltrials.gov

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