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| Name | Class |
|---|---|
| Skane University Hospital | OTHER |
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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.
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:
Any interventional therapy for lymphedema during the follow-up is not cause for exclusion but will be registered.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevalence of lymphoedema | Other | Measures of lymphoedema |
| Measure | Description | Time Frame |
|---|---|---|
| Change in level of tissue water | Change in tissue water in the head and neck before and after cancer treatment | Baseline and after 3 and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| QoL | Quality of life measured by LyQLI | 3 and 9 months |
| Change in QoL QLQ-c30 | Change in Quality of life measured by QLQ-c30 | Baseline and after 3 and 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated for head and neck cancer at the ENT department and the Oncology department at Skane University Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Eva Ekvall Hansson, Professor | Lund University, Medical Faculty, Dep of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT department Skane University Hospital | Lund | 22100 | Sweden |
According to Swedish law, sharing IPD is not possible. De-identified data can be shared on request
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Change in QoL QLQ H&N35 | Change in Quality of life measured by QLQ H&N35 | Baseline and after 3 and 9 months |
| QoL | Quality of Life measured by Lymphedema Quality of Life Invetory (LyQLI), a scale from | After 9 months |