Lymphoedema for Persons With Head- and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in level of tissue water
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Planned for treatment with curative intent as recommended at the multidisciplinary tumour board.
- •Age >18 years. Able to give informed consent
排除标准
- •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
结局指标
主要结局
Change in level of tissue water
时间窗: Baseline and after 3 and 9 months
Change in tissue water in the head and neck before and after cancer treatment
次要结局
- Change in QoL QLQ-c30(Baseline and after 3 and 9 months)
- QoL(After 9 months)
- Change in QoL QLQ H&N35(Baseline and after 3 and 9 months)
研究者
Eva Ekvall-Hansson
Professor
Lund University