Breast CancerNCT06669910
Investıgatıon of Temporomandıbular Dysfunctıon in Patıents Wıth Breast Cancer-Related Lymphedema
An observational study of Breast Cancer and Lymphedema, run by arife akbulut at 1 site in Turkey (Türkiye).
Trial summary
This study is the first study to examine temporomandibular joint dysfunction (TMD) in patients with breast cancer. The aim of the study was to investigate the relationship between lymphedema (LÖ) and TMD in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- only assesment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 31 Jul 2024
- Phase
- Observational
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients who were treated for unilateral breast cancer and developed breast cancer-related LE
Who may be able to join
- Female patients aged 18-75 years who were treated for unilateral breast cancer and developed breast cancer-related LE were included in the study
Who cannot join
- Patients with general joint diseases affecting the head and neck region that may cause TMD (e.g. rheumatoid arthritis),
- jaw fracture,
- trauma or orthognathic surgery history,
- cervical disc herniation,
- congenital disease,
- facial paralysis,
- patients who have been treated for TMD for the last 3 months and patients who use antidepressant drugs were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This study is the first study to examine temporomandibular joint dysfunction (TMD) in patients with breast cancer. The aim of the study was to investigate the relationship between lymphedema (LÖ) and TMD in patients with breast cancer. Socio-demographic characteristics of 38 individuals included in the study were recorded. Patients were divided into stage 0, 1 and 2 groups according to their LÖ stage and mild, moderate and advanced groups according to their TMD levels. In the evaluation of severity of lymphedema, Symptoms and Signs of TMD, pain threshold and tolerance assessment and normal range of motion, anxiety and depression, posture analysis environmental measurement, Craniomandibular Dysfunction Index for Clinical, Visual Analogue Scale (VAS) and algometer , goniometer and inclinometer, Turkish version of the Hospital Anxiety and Depression Scale (HAD) ,photogrammetric assessment method and inclinometer were used
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- only assesment
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
only assesmentOther
only assesment
| Study group | Role | What they receive |
|---|---|---|
| mild TMD | Not described Receives: Other: only assesment | |
| moderate TMD | Not described Receives: Other: only assesment | |
| advanced TMD | Not described Receives: Other: only assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
temporomandibular dysfunction
The Clinical Craniomandibular Dysfunction Index (CDI) was used. CDI consists of five components including limited mandibular normal joint motion (RMJ), pain during mandibular RMJ, pain during TMJ palpation, pain during palpation of masticatory muscles and pain during mandibular function. 3 points can be given for each component as 0, 1 or 5 points and individuals are graded as no TMD (0 points), mild TMD (1-4 points), moderate TMD (5-9 points) and severe TMD (10-25 points) according to the scores received.
Measured: through study completion, an average of 1 year
lymhedema
It was determined according to the criteria determined by the International Lymphology Association . To determine the severity of LE, circumference measurements were taken from both arms at 4 cm intervals. If the difference between the two extremities was up to 1.5 cm, it was classified as "normal", between 1.5-3 cm as "mild", between 3-5 cm as "moderate" and over 5 cm as "severe" LE
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
pain
The pain was assessed with the Visual Analog Scale (VAS) at rest and activity. Patients were asked to mark the point that best described their pain on a 10 cm line (0: no pain, 10: unbearable pain). The pain intensity with activity was assessed during mouth opening, mouth closing and 60 seconds of gum chewing. Patients were asked to chew gum using both sides for 60 seconds. At the end of this period, patients evaluated their pain in the TMJ according to the VAS
Measured: through study completion, an average of 1 year
posture
Kyphosis and lordosis angles of the patients were measured with Baseline® Digital inclinometer while the patients were standing in a comfortable position. "Posture Analysis Method with Photography" was used.
Measured: through study completion, an average of 1 year
Measurement of range of motion of cervical joints and shoulder joint
The measurements were made with a Baseline® universal goniometer with a plastic 360 degree quadrant. Flexion, extension, right-left lateral flexion and rotation angles for the cervical region, and flexion, abduction, external and internal rotation ROM angles for the shoulder joint were measured. The measurements were made in the sitting position for the cervical region and in the supine position for the shoulder. Each measurement was repeated 3 times and the average values were recorded.
Measured: through study completion, an average of 1 year
anxiety-depression
The Turkish version of the Hospital Anxiety and Depression Scale (HAD) was used. HAD is a 4-point Likert-type scale with a score between 0 and 21, consisting of 14 questions, 7 of which evaluate anxiety and 7 of which evaluate depression.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Nov 2019
- Primary completion31 Mar 2020
- Study completion31 Jul 2024
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 Breast 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- arife akbulut
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Sponsor-investigator, arife akbulut, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669910
- Sponsor's protocol ID
- AYBU-AKBULUT-001
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akbulut Bayrak A, Tekbudak MY, Gultekin S, Keser I. Investigation of temporomandibular dysfunction in patients with breast cancer-related lymphedema. Support Care Cancer. 2025 May 7;33(6):455. doi: 10.1007/s00520-025-09500-y.
PubMed 40332621
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investıgatıon of Temporomandıbular Dysfunctıon in Patıents Wıth Breast Cancer-Related Lymphedema
- ClinicalTrials.gov ID
- NCT06669910
- Acronym / sponsor ID
- AYBU-AKBULUT-001
- Conditions
- Breast Cancer, Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- arife akbulutUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 1 Nov 2024 (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.
This study is the first study to examine temporomandibular joint dysfunction (TMD) in patients with breast cancer. The aim of the study was to investigate the relationship between lymphedema (LÖ) and TMD in patients with breast cancer. Socio-demographic characteristics of 38 individuals included in the study were recorded. Patients were divided into stage 0, 1 and 2 groups according to their LÖ stage and mild, moderate and advanced groups according to their TMD levels. In the evaluation of severity of lymphedema, Symptoms and Signs of TMD, pain threshold and tolerance assessment and normal range of motion, anxiety and depression, posture analysis environmental measurement, Craniomandibular Dysfunction Index for Clinical, Visual Analogue Scale (VAS) and algometer , goniometer and inclinometer, Turkish version of the Hospital Anxiety and Depression Scale (HAD) ,photogrammetric assessment method and inclinometer were used
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild TMD | – | Other: only assesment |
| moderate TMD | – | Other: only assesment |
| advanced TMD | – | Other: only assesment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients who were treated for unilateral breast cancer and developed breast cancer-related LE
Key inclusion criteria (1 listed)
- Female patients aged 18-75 years who were treated for unilateral breast cancer and developed breast cancer-related LE were included in the study
Key exclusion criteria (7 listed)
- Patients with general joint diseases affecting the head and neck region that may cause TMD (e.g. rheumatoid arthritis),
- jaw fracture,
- trauma or orthognathic surgery history,
- cervical disc herniation,
- congenital disease,
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 |
|---|---|---|
| only assesmentonly assesment | Other | advanced TMD, mild TMD, moderate TMD |
Primary outcome
temporomandibular dysfunction
Time frame: through study completion, an average of 1 year
The Clinical Craniomandibular Dysfunction Index (CDI) was used. CDI consists of five components including limited mandibular normal joint motion (RMJ), pain during mandibular RMJ, pain during TMJ palpation, pain during palpation of masticatory muscles and pain during mandibular function. 3 points can be given for each component as 0, 1 or 5 points and individuals are graded as no TMD (0 points), mild TMD (1-4 points), moderate TMD (5-9 points) and severe TMD (10-25 points) according to the scores received.
lymhedema
Time frame: through study completion, an average of 1 year
It was determined according to the criteria determined by the International Lymphology Association . To determine the severity of LE, circumference measurements were taken from both arms at 4 cm intervals. If the difference between the two extremities was up to 1.5 cm, it was classified as "normal", between 1.5-3 cm as "mild", between 3-5 cm as "moderate" and over 5 cm as "severe" LE
4 secondary outcomes
pain
Time frame: through study completion, an average of 1 year
posture
Time frame: through study completion, an average of 1 year
Measurement of range of motion of cervical joints and shoulder joint
Time frame: through study completion, an average of 1 year
anxiety-depression
Time frame: through study completion, an average of 1 year
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 1 Nov 2024.
- Derived from this study: PubMed 40332621Akbulut Bayrak A, Tekbudak MY, Gultekin S, Keser I. Investigation of temporomandibular dysfunction in patients with breast cancer-related lymphedema. Support Care Cancer. 2025 May 7;33(6):455. doi: 10.1007/s00520-025-09500-y.
- 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?
An observational study of Breast Cancer and Lymphedema, run by arife akbulut 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 1 inclusion and 7 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 1 Nov 2024. 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?
temporomandibular dysfunction (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT06669910, 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 1 Nov 2024.