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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316974
• Other study ID #: 2020-01066
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Lund University
• Contact: Agneta Hagren, MSc
• Phone: +4646175964
• Email: agneta.hagren[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Prevalence of lymphoedema
Measures of lymphoedema

Locations

Country	Name	City	State
Sweden	ENT department Skane University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	QoL	Quality of life measured by LyQLI	3 and 9 months
Secondary	Change in QoL QLQ-c30	Change in Quality of life measured by QLQ-c30	Baseline and after 3 and 9 months
Secondary	Change in QoL QLQ H&N35	Change in Quality of life measured by QLQ H&N35	Baseline and after 3 and 9 months
Secondary	QoL	Quality of Life measured by Lymphedema Quality of Life Invetory (LyQLI), a scale from	After 9 months