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Completed

NCT Number: NCT05316974

Lymphoedema Among 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ENT department Skane University Hospital

Lund, 22100, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Prevalence of lymphoedema

Other

Measures of lymphoedema

Primary outcomes

  1. 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

Secondary outcomes

  1. QoL

    Time frame: 3 and 9 months

    Quality of life measured by LyQLI

  2. Change in QoL QLQ-c30

    Time frame: Baseline and after 3 and 9 months

    Change in Quality of life measured by QLQ-c30

  3. Change in QoL QLQ H&N35

    Time frame: Baseline and after 3 and 9 months

    Change in Quality of life measured by QLQ H&N35

  4. QoL

    Time frame: After 9 months

    Quality of Life measured by Lymphedema Quality of Life Invetory (LyQLI), a scale from

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Skane University Hospital

Registry information

Official study title

Lymphoedema for Persons With Head- and Neck Cancer

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 7, 2022
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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