Head and Neck CancerNCT07376213
Effects of a Home-Based Exercise Program During Radiotherapy
A study testing Home-based exercise in people with Head and Neck Cancer, run by Burak Ertürk at 1 site in Turkey (Türkiye).
Trial 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. Exercise may help reduce or prevent the loss of normal range of motion that can occur during radiotherapy. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Home-based exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2022to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences
Ankara
About this study
Official 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
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:
- Exercise may help reduce or prevent the loss of normal range of motion that can occur during radiotherapy.
- Exercise may help maintain muscle strength or lead to improvements in muscle strength.
- Exercise may help maintain or improve postural alignment.
- Conditions
- Head and Neck Cancer
- Being tested
- Home-based exercise
- Keywords
- head and neck neoplasms, Radiotherapy, Exercise, Physiotherapy, Lymphedema
- Medical subject headings
- Head and Neck Neoplasms, Motor Activity, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exerciseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 25 (end of radiotherapy)
Secondary outcomes (5)
Muscle Strength
Muscle strength of the cervical and shoulder girdle muscles will be evaluated using manual muscle testing.
Measured: Baseline and Day 25 (end of radiotherapy)
Postural Alignment
Postural alignment will be assessed through observational postural analysis focusing on head, neck, and shoulder alignment.
Measured: Baseline and Day 25 (end of radiotherapy)
Fibrosis Severity
Radiation-induced fibrosis will be evaluated using a standardized clinical fibrosis grading scale.
Measured: Day 25 (end of radiotherapy)
Lymphedema
Head and neck lymphedema will be assessed using circumferential measurements and/or clinical lymphedema grading.
Measured: Day 25 (end of radiotherapy)
Swallowing Function
Swallowing function will be evaluated using a validated swallowing assessment scale (Swal-QoL).
Measured: Baseline and Day 25 (end of radiotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start2 Jan 2022
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burak Ertürk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burak Ertürk, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376213
- Sponsor's protocol ID
- E-77082166-302.08.01-805534
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erturk B, Duzlu M, Erpolat OP, Keser I. Prophylactic Home-Based Exercises During Radiotherapy in Head and Neck Cancer: A Randomized Controlled Trial. Otolaryngol Head Neck Surg. 2026 Sep 13. doi: 10.1002/ohn.70442. Online ahead of print.
PubMed 42732471
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07376213
- Acronym / sponsor ID
- E-77082166-302.08.01-805534
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck neoplasms, Radiotherapy, Exercise, Physiotherapy, Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Burak ErtürkUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Exercise may help reduce or prevent the loss of normal range of motion that can occur during radiotherapy.
- Exercise may help maintain muscle strength or lead to improvements in muscle strength.
- Exercise may help maintain or improve postural alignment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Home-Based Physiotherapy Program | Experimental | Procedure: Home-based exerciseParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exerciseThe 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. | Procedure or surgery | Structured Home-Based Physiotherapy Program |
Primary outcome
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.
5 secondary outcomes
Muscle Strength
Time frame: Baseline and Day 25 (end of radiotherapy)
Postural Alignment
Time frame: Baseline and Day 25 (end of radiotherapy)
Fibrosis Severity
Time frame: Day 25 (end of radiotherapy)
Lymphedema
Time frame: Day 25 (end of radiotherapy)
Swallowing Function
Time frame: Baseline and Day 25 (end of radiotherapy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Derived from this study: PubMed 42732471Erturk B, Duzlu M, Erpolat OP, Keser I. Prophylactic Home-Based Exercises During Radiotherapy in Head and Neck Cancer: A Randomized Controlled Trial. Otolaryngol Head Neck Surg. 2026 Sep 13. doi: 10.1002/ohn.70442. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise in people with Head and Neck Cancer, run by Burak Ertürk at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: Baseline and Day 25 (end of radiotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07376213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.