Lymphoedema Among Persons With Head- and Neck Cancer

NCT05316974 | Completed

• 1 other identifier: 2020-01066
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer of Head and Neck

Keywords

Lymphoedema; Quality of life; Head and neck cancer treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• QoL

  3 and 9 months

• Change in QoL QLQ-c30

  Baseline and after 3 and 9 months

• Change in QoL QLQ H&N35

  Baseline and after 3 and 9 months

• QoL

  After 9 months

Interventions

Prevalence of lymphoedema OTHER

Measures of lymphoedema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• Skane University Hospital: collaborator

Study Sites (1)

ENT department Skane University Hospital

Lund, 22100, Sweden

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Eva Ekvall Hansson, Professor

  Lund University, Medical Faculty, Dep of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 7, 2022
• Study Start: October 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: April 4, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)