Lymphoedema Among Persons With Head- and Neck Cancer

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Head and Neck
• Intervention / Treatment: Other: Prevalence of lymphoedema

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:

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22100
    • ENT department Skane University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients treated for head and neck cancer at the ENT department and the Oncology department at Skane University Hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Skane University Hospital
• Investigators: Principal Investigator: Eva Ekvall Hansson, Professor, Lund University, Medical Faculty, Dep of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): April 4, 2025

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Lymphoedema; Head and neck cancer treatment
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphedema; Head and Neck Neoplasms
• Other Study ID Numbers: 2020-01066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to Swedish law, sharing IPD is not possible. De-identified data can be shared on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No