Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer

NCT ID: NCT04894149

Last Updated: 2021-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2023-05-31

Brief Summary

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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

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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

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Physiotherapy

Group Type EXPERIMENTAL

Physiotherapy

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gabriella Alexandersson von Döbeln

OTHER

Sponsor Role lead

Responsible Party

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Gabriella Alexandersson von Döbeln

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Karolinska University hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Gabriella A von Döbeln, MD, PhD

Role: CONTACT

+46 8 517 700 00

Facility Contacts

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Gabriella Alexandersson von Dobeln, MD, PhD

Role: primary

Other Identifiers

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21/001

Identifier Type: -

Identifier Source: org_study_id

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