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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

Fitness AfteR Oesophagectomy - an external pilot trial of the impact of rehabilitation on quality of life after surgery for oesophageal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73024784
Enrollment
60
Registered
2021-11-02
Start date
2021-10-18
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophageal cancer Cancer

Interventions

Sixty patients will be recruited into the study from one centre (Northern Oesophagogastric Unit, Royal Victoria Infirmary, Newcastle Upon Tyne), with 30 patients in each group. The rehabilitation pr

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
1. Physical fitness- measured using the 6-minute walking test at 6 weeks post-hospital discharge and 3- and 6 months post-oesophagectomy. 2. Post-operative physical activity levels- measured by an activity tracker and patient-recorded study diary at 6 weeks post-hospital discharge and 3- and 6 months post-oesophagectomy. 3. Functional impact of sarcopenia (generalised loss of muscle mass and strength) - measured by hand-grip strength at 6 weeks post-hospital discharge and 3- and 6 months post-oesophagectomy. 4. Recruitment rate- measured by the proportion of eligible patients successfully recruited at the end of the study period. 5. Individual compliance- measured by activity tracker and concordance with study diary during the 6-month patient enrollment. 6. Effects of dietary counselling- measured by changes in micronutrient levels on blood tests and weight at 6 weeks post-hospital discharge and 3- and 6 months post-oesophagectomy.

Countries

England, United Kingdom

Contacts

Public ContactPooja Prasad
p.prasad2@newcastle.ac.uk+44 (0)1912336161

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026