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Clinical Trials/NCT04894149
NCT04894149
Unknown
Not Applicable

Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer

Gabriella Alexandersson von Döbeln1 site in 1 country25 target enrollmentApril 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
Gabriella Alexandersson von Döbeln
Enrollment
25
Locations
1
Primary Endpoint
Adherence to exercise sessions.
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2021
End Date
May 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Gabriella Alexandersson von Döbeln
Responsible Party
Sponsor Investigator
Principal Investigator

Gabriella Alexandersson von Döbeln

Principal Investigator

Karolinska University Hospital

Eligibility Criteria

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-
  • 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.

Outcomes

Primary Outcomes

Adherence to exercise sessions.

Time Frame: Up to 40 weeks

Percentage of sessions completed out of number of sessions planned

Un-planned interruptions in the prehabilitation/rehabilitation programme

Time Frame: Up to 40 weeks

Percentage of patients having an unplanned interruption of ten days or more of the supervised prehabilitation/rehabilitation programme

Study Sites (1)

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