Prehabilitation of Patients With oEsophageal Malignancy Undergoing Peri-operative Treatment

Surgery Clinical Trial

— Pre-EMPT  

Official title:

'Pre-EMPT' - An Interventional Study to Assess the Effects of Pre-emptive Exercise , or 'Prehabilitation', in Patients Undergoing Peri-operative Treatment for Adenocarcinoma of the Oesophagus and Gastro-oesophageal Junction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03626610
• Other study ID #: IRAS 204711 Pre-EMPT PROTOCOL
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: June 2021

Study information

• Verified date: August 2018
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Janine Zylstra
• Phone: +44 (0) 20 7188 7188
• Email: janine.zylstra[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

'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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 18+

3. </=79 (patients above this age may be included in studies after the feasibility study has been completed)

4. Participants must be able to understand and independently consent to participation in the study.

5. Participants must be able to understand and complete the questionnaires.

6. 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.

7. Participants must be willing to wear the Fibit monitoring device and agree with its use

8. Participants must be ASA 1-3 and fit for surgical resection

9. 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:

1. Are not considered medically fit for surgery at diagnosis, as decided by the Multidisciplinary team

2. Will undergo primary or palliative chemotherapy

3. Are recommended to have chemoradiotherapy

4. Are under 18 years old

5. Are over 79 years old

6. Are unable to undergo CPEX testing

7. Do not wish to take part in selected aspects of the study

8. Cannot or do not wish to attend the CHHP for assessment and/or advice on exercise

9. Cannot understand and give informed consent to the study

10. Cannot understand and complete the questionnaires

11. Do not wish to wear a Fitbit monitoring device

12. ASA 4+

13. Patients with BMI of less than 18.5 with self-reported unintentional weight loss of 10% or more at diagnosis.

Related Conditions & MeSH terms

• Adenocarcinoma
• Chemotherapy Effect
• Esophageal Neoplasms
• Oesophageal Adenocarcinoma
• Surgery

Intervention

Behavioral:
• Exercise prehabilitation during chemotherapy before surgery
Monitored exercise training in patients with a new diagnosis of oesophageal adenocarcinoma

Locations

Country	Name	City	State
United Kingdom	St Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary fitness	Cardiopulmonary exercise test on bicycle ergometer	Baseline to 5 months
Secondary	Post-operative complications	Clavien-Dindo; ECCG- Esophageal Complications Consensus Group	Date of surgery to date of discharge, up to 45 days post-surgery
Secondary	Post-operative length of hospital stay	Number of in-hospital days from date of surgery	Date of surgery to date of discharge, up to 45 days post-surgery
Secondary	Lean body mass	Computerised tomography assessment of lean body mass	Baseline to 5 months
Secondary	Daily activity levels	Steps per day measured by Fitbit	Baseline to 5 months
Secondary	Sleep quality assessment	Sleep data from Fitbit	Baseline to 5 months
Secondary	Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire	EORTC QLQ-OES18	Baseline to 12 months post-surgery
Secondary	Change in Health-related Quality of Life: Cancer questionniare	EORTC QLQ-C30	Baseline to 12 months post-surgery
Secondary	Change in Well-being	SWEMWEBS questionnaire	Baseline to 12 months post-surgery
Secondary	Disease recurrence	Pathological or radiological confirmation of recurrent disease	Date of surgery to date of recurrence, up to 12 months post-surgery
Secondary	Post-operative mortality	In-patient, 30-day, 90-day, 1-year	Date of surgery to date of death, up to 12 months post-surgery