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Status unknownNCT04894149PRESOUpdated May 20, 2021

Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer

An interventional study of Physiotherapy in Esophageal Cancer, sponsored by Gabriella Alexandersson von Döbeln. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.

Sponsored by Gabriella Alexandersson von Döbeln · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Esophageal Cancer
03

In context

Lead sponsor

Gabriella Alexandersson von Döbeln is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Physiotherapy

    Other: Physiotherapy

Interventions

  • OtherPhysiotherapy

    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)

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What researchers measure

Primary outcomes

  1. Adherence to exercise sessions.

    Percentage of sessions completed out of number of sessions planned

    Time frame: Up to 40 weeks

  2. 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

    Time frame: Up to 40 weeks

07

Study locations

1 of 1 sites recruiting
  • Karolinska University hospital
    Stockholm, Sweden
    • Gabriella Alexandersson von Dobeln, MD, PhD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04894149
Lead sponsor
Gabriella Alexandersson von Döbeln
Responsible party
Gabriella Alexandersson von Döbeln (Principal Investigator, Karolinska University Hospital) — Sponsor-investigator
First posted
May 20, 2021
Start date
Apr 22, 2021
Primary completion
Jan 2023 (estimated)
Completion
May 2023 (estimated)
Last update
May 20, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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