Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer

Esophageal Cancer Clinical Trial

— PRESO  

Official title:

Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04894149
• Other study ID #: 21/001
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: May 2023

Study information

• Verified date: May 2021
• Source: Karolinska University Hospital
• Contact: Gabriella A von Döbeln, MD, PhD
• Phone: +46 8 517 700 00
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

Other:
• Physiotherapy
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)

Locations

Country	Name	City	State
Sweden	Karolinska University hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Gabriella Alexandersson von Döbeln

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to exercise sessions.	Percentage of sessions completed out of number of sessions planned	Up to 40 weeks
Primary	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