Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer
PRESO
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2021
CompletedFirst Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedMay 20, 2021
May 1, 2021
1.7 years
May 4, 2021
May 16, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Adherence to exercise sessions.
Percentage of sessions completed out of number of sessions planned
Up to 40 weeks
Un-planned interruptions in the prehabilitation/rehabilitation programme
Percentage of patients having an unplanned interruption of ten days or more of the supervised prehabilitation/rehabilitation programme
Up to 40 weeks
Study Arms (1)
Physiotherapy
EXPERIMENTALInterventions
Supervised physiotherapy one hour twice weekly and 20 minutes three times weekly during 14- 17 weeks before surgery during neoadjuvant chemotherapy or chemoradiotherapy and during eight weeks after surgery (sometimes during adjuvant chemotherapy)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University hospital
Stockholm, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 20, 2021
Study Start
April 22, 2021
Primary Completion
January 1, 2023
Study Completion
May 1, 2023
Last Updated
May 20, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share