Lymphoedema Among Persons With Head- and Neck Cancer

Cancer of Head and Neck Clinical Trial

Official title: Lymphoedema for Persons With Head- and Neck Cancer

Status Recruiting

Clinical 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 treatment, and to evaluate the quality of life before and after cancer treatment.

Clinical Trial 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:

1. Patient request

2. Locoregional tumor progression or failure during the study period. For example, residual neck tumor requiring neck dissection after (C)RT for OPC

3. 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. ;

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms
• Lymphedema

• NCT number: NCT05316974
• Study type: Observational
• Source: Lund University
• Contact: Agneta Hagren, MSc
• Phone: +4646175964
• Email: agneta.hagren@med.lu.se
• Status: Recruiting
• Start date: October 1, 2022
• Completion date: December 31, 2024