Assessing lymphedema in head and neck cancer patients
Lymphoedema for Persons With Head- and Neck Cancer
This study is testing how common lymphedema is in people with head and neck cancer by checking their tissue water levels and neck size before and after treatment, while also looking at their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lund University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lund) |
| Trial ID | NCT05316974 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence of lymphedema in patients diagnosed with head and neck cancer by measuring tissue water content before and after various cancer treatments. Participants will undergo assessments using a MoistureMeterD device and neck circumference measurements, alongside quality of life evaluations through standardized questionnaires at baseline, 3 months, and 9 months post-treatment. The study will also track any interventional therapies for lymphedema that may occur during the follow-up period.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with biopsy-confirmed head and neck cancer who are planned for curative treatment.
Not a fit: Patients who have previously received treatment for head and neck cancer or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of lymphedema prevalence and its impact on quality of life for patients with head and neck cancer.
How similar studies have performed: While studies on lymphedema in cancer patients exist, this specific approach focusing on head and neck cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lund
- ENT department Skane University Hospital — Lund, Sweden (Recruiting)
Study contacts
- Principal investigator: Eva Ekvall Hansson, Professor — Lund University, Medical Faculty, Dep of Health Sciences
- Study coordinator: Agneta Hagren, MSc
- Email: agneta.hagren@med.lu.se
- Phone: +4646175964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.