Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer

Not Applicable

• Conditions: Esophageal Cancer
• Interventions: Other: Physiotherapy

• Registration Number: NCT04894149
• Lead Sponsor: Gabriella Alexandersson von Döbeln

Brief Summary

Patients with oesophageal cancer selected for oncological and surgical treatment with curative intent are offered supervised physiotherapy and home-based training before and after surgery.

Detailed Description

Patients with loco-regional oesophageal cancer who will receive neoadjuvant chemotherapy or chemoradiotherapy followed by surgery and sometimes adjuvant chemotherapy are eligible to be enrolled in the trial. Study treatment is supervised group training twice weekly and home-based training three times weekly during neoadjuvant treatment and after surgery.

Study Timeline

• Study Start: 2021-04-22
• Status Verified: 2021-05
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-16
• Last Update Submitted: 2021-05-16
• Study First Posted: 2021-05-20
• Last Update Posted: 2021-05-20
• Primary Completion: 2023-01
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Histopathologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma in the oesophagus or cardia (Siewert I or II), cT1 N+ or cT2-4a any N, M0, according to the 8th version of the AJCC TNM classification.
• Assessed at a multidisciplinary conference to be suitable for curatively intended oncological and surgical treatment.
• Age > 18 years.
• Performance status ECOG 0-2.
• Patient has provided written informed consent.

Exclusion Criteria

• Previous radiotherapy in the thorax (except for tangential field radiotherapy for breast cancer).
• Inability to understand written and spoken instructions and to comply with protocol requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physiotherapy	Physiotherapy	-

Primary Outcome Measures

Name	Time	Method
Adherence to exercise sessions.	Up to 40 weeks	Percentage of sessions completed out of number of sessions planned
Un-planned interruptions in the prehabilitation/rehabilitation programme	Up to 40 weeks	Percentage of patients having an unplanned interruption of ten days or more of the supervised prehabilitation/rehabilitation programme

Trial Locations

Locations (1)

Karolinska University hospital; 🇸🇪 Stockholm, Sweden