Preventive Physical Activity Intervention in Head and Neck Cancer

NCT ID: NCT05432297

Last Updated: 2024-11-29

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

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2031-12-31

Brief Summary

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The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment

Detailed Description

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Conditions

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Head and Neck Neoplasms Physical Inactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Physical exercise intervention

The physical activity intervention is based on national guidelines of physical activity in cancer rehabilitation. A physiotherapist together with each patient will develop individual adaptations to the exercise protocol, with suggestions on which type of exercise the participant is able to perform depending on their daily condition. Suggestions on physical activity for good, bad and in-between-days will be listed in collaboration with the participant, and the participant will report number of minutes/day in each of the 3 physical activity levels stated.

Group Type EXPERIMENTAL

Preventive physical exercise

Intervention Type BEHAVIORAL

Daily physical activity depending on daily condition

Control

The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preventive physical exercise

Daily physical activity depending on daily condition

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
* Receiving radiohterapy (+/- chemotherapy) with curative intent

Exclusion Criteria

* Surgery due to head and neck cancer
* Previous treatment for head and neck cancer
* Tracheostomized patients
* Inability to perform exercise intervention
* Inability to perform part of 6-minute walking test
* Inability to independently fill out questionnaires in Swedish
* Previous neurologic or neuromuscular disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lisa Tuomi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa Tuomi, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Lisa Tuomi, PhD

Role: CONTACT

+46313421000

Facility Contacts

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Lisa Tuomi

Role: primary

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id