Improving fitness after gullet cancer surgery: a pilot trial of the impact of rehabilitation on quality of life, physical fitness and nutrition following surgery for cancer of the gullet

Not Applicable

• Conditions: Oesophageal cancer; Cancer

• Registration Number: ISRCTN73024784
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-02
• Last Update Posted: 23 May 2022
• Study Completion: 2024-08-02

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Any patient undergoing a curative trans-thoracic oesophagectomy for malignancy. This includes open or minimally invasive or robotic Ivor Lewis oesophagectomy and three-stage three-field oesophagectomy with cervical anastomoses.
2. Age 18 years or over
3. Ability to provide consent to participation.
4. Ability to be able to complete planned interventions within the programme.
5. Any patient undergoing an oesophagectomy for cancer

Patients who have or due to undergo neoadjuvant or adjuvant chemotherapy will be included in the study, provided they meet the above inclusion criteria

Exclusion Criteria

1. Absolute and relative contraindications to the 6-minute walk test, as defined by the American Thoracic Society.
2. Orthopaedic limitations to participating in the study intervention (daily walking and/or daily exercise), for example severe hip or knee disease such as osteoarthritis; lower limb amputation.
3. Post-operative complications precluding participation, for example- neutropenic sepsis with prolonged hospital admission during a cycle of adjuvant chemotherapy- such that the patient cannot commence the programme within 12 weeks of having their surgery.
4. Prolonged post-operative recovery that prevents commencing participation in study within 12 weeks of having their surgery.
5. Oesophago-gastrectomy with colonic interposition.
6. Patients with concurrent malignancies requiring surgical treatment (e.g.: breast) or radio/chemotherapy or immunotherapy (e.g.: haematological malignancies)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life measured using European Organisation For Research and Treatment of Cancer (EORTC) QLQ-C30 and OG-25 questionnaires at 6 weeks post-discharge from hospital (after oesophagectomy); 3- and 6 months post-oesophagectomy