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Completed

NCT Number: NCT07376213

Effects of a Home-Based Exercise Program During Radiotherapy

The purpose of this study is to examine the effects of exercise on individuals with head and neck cancer who are receiving postoperative radiotherapy.

The study is based on three primary hypotheses:

1. Exercise may help reduce or prevent the loss of normal range of motion that can occur during radiotherapy. 2. Exercise may help maintain muscle strength or lead to improvements in muscle strength. 3. Exercise may help maintain or improve postural alignment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University, Faculty of Health Sciences

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of squamous cell carcinoma of the head and neck.
  • Undergoing unilateral neck dissection surgery.
  • Scheduled to receive curative radiotherapy.
  • Age 18 years or older.
  • Willingness to participate and ability to comprehend exercise instructions.

Exclusion criteria

  • Presence of distant metastasis.
  • Presence of a tracheostomy.
  • History of previous trauma or surgery involving the shoulder or cervical region.
  • Neurological disorders affecting upper quadrant function. Recurrence of disease during the study period.

Treatment and study plan

Home-based exercise

Procedure

The home-based rehabilitation approach was conducted for the patients, consisting of neck and upper extremity mobilization, strengthening, stretching, and breathing exercises, 5 days a week.

Primary outcomes

  1. Range of Motion

    Time frame: Baseline and Day 25 (end of radiotherapy)

    Range of motion of the cervical region will be assessed using a cervical range of motion (CROM) device, and shoulder range of motion will be assessed using a goniometer, including flexion, extension, lateral flexion, rotation, abduction, and external rotation.

Secondary outcomes

  1. Muscle Strength

    Time frame: Baseline and Day 25 (end of radiotherapy)

    Muscle strength of the cervical and shoulder girdle muscles will be evaluated using manual muscle testing.

  2. Postural Alignment

    Time frame: Baseline and Day 25 (end of radiotherapy)

    Postural alignment will be assessed through observational postural analysis focusing on head, neck, and shoulder alignment.

  3. Fibrosis Severity

    Time frame: Day 25 (end of radiotherapy)

    Radiation-induced fibrosis will be evaluated using a standardized clinical fibrosis grading scale.

  4. Lymphedema

    Time frame: Day 25 (end of radiotherapy)

    Head and neck lymphedema will be assessed using circumferential measurements and/or clinical lymphedema grading.

  5. Swallowing Function

    Time frame: Baseline and Day 25 (end of radiotherapy)

    Swallowing function will be evaluated using a validated swallowing assessment scale (Swal-QoL).

Sponsors and collaborators

Lead sponsor

Burak Ertürk

Other

Registry information

Official study title

Investigation of the Effects of Home-Based Exercise Program Applied During Radiotherapy on Posture, Range of Motion, Muscle Strength, Fibrosis, Lymphedema and Swallowing Functions in Patients Diagnosed With Head and Neck Cancer

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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