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Pre-habilitation of Patients With Head and Neck Cancer

NCT02385929 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-03-27

No results posted yet for this study

Summary

The purpose of this study is to explore whether early initiated physical exercise concurrent with a swallowing and mouth opening exercise program will have a positive effect on swallowing function and other quality of life aspects in patients treated with radiotherapy for head and neck cancer. The investigators hypothesize that patients who complete the program will have improved swallowing function and physical function one year after completing their treatment compared to patients who do not participate in the training program.

Conditions

Interventions

BEHAVIORAL

Swallowing therapy & resistance training

i) Individual instructions in swallowing and mouth opening exercises 3 days per week by occupational therapist throughout radiotherapy, ii) Progressive resistance training twice weekly by physiotherapist, either individually or group based, throughout radiotherapy, iii) Daily home-based swallowing and mouth opening exercises from beginning of treatment until 2 months after end-of-treatment. iv) Weekly follow-up phone contacts with occupational therapists from end-of-treatment and 2 months onwards.

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • Danish Association of Occupational Therapist

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Danish Cancer Research Foundation

    collaborator OTHER

  • Irene Wessel

    lead OTHER

Principal Investigators

  • Sara F Hajdú, M.Sc · Rigshospitalet, Denmark

  • Susanne O Dalton, professor · Danish Cancer Society

  • Christoffer Johansen, professor · Rigshospitalet, Denmark

  • Irene Wessel, MD, phd · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-11
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385929 on ClinicalTrials.gov