Clinical trial NCT05316974: Lymphoedema Among Persons With Head- and Neck Cancer
Official title: Lymphoedema for Persons With Head- and Neck Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of Head and Neck
Keywords: Lymphoedema
Quality of life
Head and neck cancer treatment
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Skane University Hospital
First posted: 2022-04-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in level of tissue water
timeFrame: Baseline and after 3 and 9 months
Secondary outcomes:
measure: QoL
timeFrame: 3 and 9 months
measure: Change in QoL QLQ-c30
timeFrame: Baseline and after 3 and 9 months
measure: Change in QoL QLQ H&N35
timeFrame: Baseline and after 3 and 9 months
measure: QoL
timeFrame: After 9 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: ENT department Skane University Hospital
Study officials:
affiliation: Lund University, Medical Faculty, Dep of Health Sciences
name: Eva Ekvall Hansson, Professor
role: PRINCIPAL_INVESTIGATOR
References: