Esophageal CancerPRESONCT04894149
Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer
A study testing Physiotherapy in people with Esophageal Cancer, run by Gabriella Alexandersson von Döbeln at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 22 Apr 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Gabriella A von Döbeln, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University hospital
Stockholm
Gabriella Alexandersson von Dobeln, MD, PhD
About this study
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.
- Conditions
- Esophageal Cancer
- Being tested
- Physiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
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 group | Role | What they receive |
|---|---|---|
| Physiotherapy | Experimental | Not described Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to exercise sessions.
Percentage of sessions completed out of number of sessions planned
Measured: 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
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start22 Apr 2021
- Primary completionJan 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gabriella Alexandersson von Döbeln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriella Alexandersson von Döbeln, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894149
- Sponsor's protocol ID
- 21/001
- Acronym
- PRESO
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer
- ClinicalTrials.gov ID
- NCT04894149
- Acronym / sponsor ID
- PRESO / 21/001
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Gabriella Alexandersson von DöbelnUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Experimental | Other: Physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapySupervised 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) | Other | Physiotherapy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriella A von Döbeln, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Esophageal Cancer, run by Gabriella Alexandersson von Döbeln at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriella A von Döbeln, MD, PhD (+46 8 517 700 00), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to exercise sessions. (time frame: Up to 40 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.