ENT department Skane University Hospital
Lund, 22100, Sweden
NCT Number: NCT05316974
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.
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Notify Me18 year and older
All sexes
Observational
Lund, 22100, Sweden
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measures of lymphoedema
Time frame: Baseline and after 3 and 9 months
Change in tissue water in the head and neck before and after cancer treatment
Time frame: 3 and 9 months
Quality of life measured by LyQLI
Time frame: Baseline and after 3 and 9 months
Change in Quality of life measured by QLQ-c30
Time frame: Baseline and after 3 and 9 months
Change in Quality of life measured by QLQ H&N35
Time frame: After 9 months
Quality of Life measured by Lymphedema Quality of Life Invetory (LyQLI), a scale from
Lund University
Other
Lymphoedema for Persons With Head- and Neck Cancer
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