NCT07376213

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

January 21, 2026

Last Update Submit

January 29, 2026

Conditions

Head and Neck Cancer

Keywords

head and neck neoplasmsRadiotherapyExercisePhysiotherapyLymphedema

Outcome Measures

Primary Outcomes (1)

  • Range of Motion

    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.

    Baseline and Day 25 (end of radiotherapy)

Secondary Outcomes (5)

  • Muscle Strength

    Baseline and Day 25 (end of radiotherapy)

  • Postural Alignment

    Baseline and Day 25 (end of radiotherapy)

  • Fibrosis Severity

    Day 25 (end of radiotherapy)

  • Lymphedema

    Day 25 (end of radiotherapy)

  • Swallowing Function

    Baseline and Day 25 (end of radiotherapy)

Study Arms (2)

Structured Home-Based Physiotherapy Program

EXPERIMENTAL

Participants in the intervention group will receive instruction in a structured home-based exercise program to be implemented throughout the radiotherapy period. Adherence, technique, and progression will be monitored and reinforced through weekly in-person sessions with a qualified professional.

Procedure: Home-based exercise

Usual Care / Standard Follow-Up

NO INTERVENTION

Participants in the control group will receive only radiotherapy and will not undergo any physiotherapy interventions during this period. At the end of the radiotherapy, both groups will be re-evaluated, and participants in the control group will then be provided with appropriate treatment and home-based exercise programs.

Interventions

Home-based exercisePROCEDURE

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.

Structured Home-Based Physiotherapy Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, Faculty of Health Sciences

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsMotor ActivityLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBehaviorLymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This was an open-label study. Outcome assessments and interventions were performed by the same researcher. Statistical analysis was conducted by an independent biostatistician.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 29, 2026

Study Start

January 2, 2022

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)