Cancer of Head and NeckNCT05316974
Lymphoedema Among Persons With Head- and Neck Cancer
An observational study of Cancer of Head and Neck, run by Lund University at 1 site in Sweden.
Trial summary
Lymphedema in the head and neck area is common after treatment for head and neck cancer. The aim of the research project is: to assess the prevalence of lymphedema in patients with head and neck cancer (HNC) by measuring the amount of tissue water in the head and neck area before and after different kinds of cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- Prevalence of lymphoedema
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2022to 4 Apr 2025
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients treated for head and neck cancer at the ENT department and the Oncology department at Skane University Hospital
Who may be able to join
- Biopsy or cytology confirmed HNC (all malignant types are accepted) from the oropharynx (OPC), oral cavity (OC) or neck metastases from unknown primary cancer of the head and neck (CUP).
- Tumour stage T1-4, N0-3.
- Planned for treatment with curative intent as recommended at the multidisciplinary tumour board.
- Age >18 years. Able to give informed consent
Who cannot join
- Previous treatment of HNC or radiation to the head and neck area.
- Planned surgery that includes free tissue transfer or pedicled flaps in the neck (local facial pedicled flaps are accepted).
- Planned neck dissection involving less than three regions of the neck.
- Planned proton therapy.
- Pre-treatment surgery or Botox injections in the tissue in the head and neck area.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lymphoedema for Persons With Head- and Neck Cancer
Lymphedema in the head and neck area is common after treatment for head and neck cancer.
The aim of the research project is:
- to assess the prevalence of lymphedema in patients with head and neck cancer (HNC) by measuring the amount of tissue water in the head and neck area before and after different kinds of cancer treatment, and to evaluate the quality of life before and after cancer treatment.
Read the detailed description
Measurement of tissue water is performed with a device (MoistureMeterD) see appendix 1. In addition, the neck circumference will be assessed with a measuring tape, according to Purcell (9), see appendix 2. The measurement will be completed by Agneta Hagren, or one of her colleagues, with specific education.
The assessments will be performed before treatment begins as part of the clinical routine (baseline), and at 3 months, and 9 months after treatment completion.
Each participant will respond to quality-of-life QLQ-c30 and QLQ H\&N35 questionnaires, appendix 3 and 4, at the same time points as the measurements of tissue water. Ratings of physical activity according to Frändin and Grimby will also be performed (23). The questionnaires will be sent home to the patients before the time for follow-up. A modified LyQLI questionnaire will be given to all patients with lymphedema and filled out at 9 months after treatment completion, appendix 5.
Post-treatment measurements +/- four weeks of the dedicated time point will be considered appropriate.
Discontinuing participation in the trial will be on:
- Patient request
- Locoregional tumor progression or failure during the study period. For example, residual neck tumor requiring neck dissection after (C)RT for OPC
- Locoregional deep infection i.e., suspected abscess at the scheduled time points for measurements.
Any interventional therapy for lymphedema during the follow-up is not cause for exclusion but will be registered.
- Conditions
- Cancer of Head and Neck
- Being tested
- Prevalence of lymphoedema
- Keywords
- Lymphoedema, Quality of life, Head and neck cancer treatment
- Medical subject headings
- Head and Neck Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence of lymphoedemaOther
Measures of lymphoedema
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of tissue water
Change in tissue water in the head and neck before and after cancer treatment
Measured: Baseline and after 3 and 9 months
Secondary outcomes (4)
QoL
Quality of life measured by LyQLI
Measured: 3 and 9 months
Change in QoL QLQ-c30
Change in Quality of life measured by QLQ-c30
Measured: Baseline and after 3 and 9 months
Change in QoL QLQ H&N35
Change in Quality of life measured by QLQ H\&N35
Measured: Baseline and after 3 and 9 months
QoL
Quality of Life measured by Lymphedema Quality of Life Invetory (LyQLI), a scale from
Measured: After 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Oct 2022
- Primary completion31 Oct 2024
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital
- Responsible party
- Principal investigator, Eva Ekvall-Hansson, Lund University
- Investigators
- Eva Ekvall Hansson, Professor, Principal investigator, Lund University, Medical Faculty, Dep of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316974
- Sponsor's protocol ID
- 2020-01066
- Status last verified
- Oct 2025
- First submitted
- 21 Mar 2022
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to Swedish law, sharing IPD is not possible. De-identified data can be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphoedema for Persons With Head- and Neck Cancer
- ClinicalTrials.gov ID
- NCT05316974
- Acronym / sponsor ID
- 2020-01066
- Conditions
- Cancer of Head and Neck
- Keywords
- Lymphoedema, Quality of life, Head and neck cancer treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Skane University Hospital
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 7 Apr 2022 (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.
Lymphedema in the head and neck area is common after treatment for head and neck cancer.
The aim of the research project is:
- to assess the prevalence of lymphedema in patients with head and neck cancer (HNC) by measuring the amount of tissue water in the head and neck area before and after different kinds of cancer treatment, and to evaluate the quality of life before and after cancer treatment.
Detailed description
Measurement of tissue water is performed with a device (MoistureMeterD) see appendix 1. In addition, the neck circumference will be assessed with a measuring tape, according to Purcell (9), see appendix 2. The measurement will be completed by Agneta Hagren, or one of her colleagues, with specific education.
The assessments will be performed before treatment begins as part of the clinical routine (baseline), and at 3 months, and 9 months after treatment completion.
Each participant will respond to quality-of-life QLQ-c30 and QLQ H\&N35 questionnaires, appendix 3 and 4, at the same time points as the measurements of tissue water. Ratings of physical activity according to Frändin and Grimby will also be performed (23). The questionnaires will be sent home to the patients before the time for follow-up. A modified LyQLI questionnaire will be given to all patients with lymphedema and filled out at 9 months after treatment completion, appendix 5.
Post-treatment measurements +/- four weeks of the dedicated time point will be considered appropriate.
Discontinuing participation in the trial will be on:
- Patient request
- Locoregional tumor progression or failure during the study period. For example, residual neck tumor requiring neck dissection after (C)RT for OPC
- Locoregional deep infection i.e., suspected abscess at the scheduled time points for measurements.
Any interventional therapy for lymphedema during the follow-up is not cause for exclusion but will be registered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated for head and neck cancer at the ENT department and the Oncology department at Skane University Hospital
Key inclusion criteria (4 listed)
- Biopsy or cytology confirmed HNC (all malignant types are accepted) from the oropharynx (OPC), oral cavity (OC) or neck metastases from unknown primary cancer of the head and neck (CUP).
- Tumour stage T1-4, N0-3.
- Planned for treatment with curative intent as recommended at the multidisciplinary tumour board.
- Age >18 years. Able to give informed consent
Key exclusion criteria (6 listed)
- Previous treatment of HNC or radiation to the head and neck area.
- Planned surgery that includes free tissue transfer or pedicled flaps in the neck (local facial pedicled flaps are accepted).
- Planned neck dissection involving less than three regions of the neck.
- Planned proton therapy.
- Pre-treatment surgery or Botox injections in the tissue in the head and neck area.
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 |
|---|---|---|
| Prevalence of lymphoedemaMeasures of lymphoedema | Other | – |
Primary outcome
Change in level of tissue water
Time frame: Baseline and after 3 and 9 months
Change in tissue water in the head and neck before and after cancer treatment
4 secondary outcomes
QoL
Time frame: 3 and 9 months
Change in QoL QLQ-c30
Time frame: Baseline and after 3 and 9 months
Change in QoL QLQ H&N35
Time frame: Baseline and after 3 and 9 months
QoL
Time frame: After 9 months
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 7 Oct 2025.
- Individual participant dataSharing planned: No. According to Swedish law, sharing IPD is not possible. De-identified data can be shared on request
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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.
Eva Ekvall Hansson, Professor principal investigator
Lund University, Medical Faculty, Dep of Health Sciences
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 Cancer of Head and Neck, run by Lund University at 1 site in Sweden.
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 4 inclusion and 6 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 7 Oct 2025. 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 Sweden. 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?
Change in level of tissue water (time frame: Baseline and after 3 and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2025.