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Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer (PRESO)

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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

Tracking Information
First Submitted Date  ICMJE May 4, 2021
First Posted Date  ICMJE May 20, 2021
Last Update Posted Date May 20, 2021
Actual Study Start Date  ICMJE April 22, 2021
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2021)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer
Official Title  ICMJE Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: Physiotherapy
Intervention: Other: Physiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2021)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gabriella A von Döbeln, MD, PhD +46 8 517 700 00
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04894149
Other Study ID Numbers  ICMJE 21/001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gabriella Alexandersson von Döbeln, Karolinska University Hospital
Study Sponsor  ICMJE Gabriella Alexandersson von Döbeln
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Karolinska University Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP