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Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer (PRESO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04894149
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Gabriella Alexandersson von Döbeln, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Other: Physiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Physiotherapy 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)




Primary Outcome Measures :
  1. Adherence to exercise sessions. [ Time Frame: Up to 40 weeks ]
    Percentage of sessions completed out of number of sessions planned

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 0-2.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894149


Contacts
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Contact: Gabriella A von Döbeln, MD, PhD +46 8 517 700 00

Locations
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Sweden
Karolinska University hospital Recruiting
Stockholm, Sweden
Contact: Gabriella Alexandersson von Dobeln, MD, PhD         
Sponsors and Collaborators
Gabriella Alexandersson von Döbeln
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Responsible Party: Gabriella Alexandersson von Döbeln, Principal Investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT04894149    
Other Study ID Numbers: 21/001
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No