The Effect of Manual Lymph Drainage for Cancer Treatment-related External Lymphedema in the Head and Neck - a Pilot and Feasibility Study of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Recruitment rate, retention rate, adverse events, and ability to collect outcomes
研究概览
简要总结
This study will evaluate the feasibility of a randomized controlled trial. The future randomized controlled trial will compare two groups following different intensities of manual lymphatic drainage for external head- and neck lymphedema among persons treated with radiotherapy for head- and neck cancer.
详细描述
Methods Study setting The study will be conducted at the Department of Otorhinolaryngology, Head & Neck Surgery, Skåne University Hospital, Lund, Sweden, a tertiary referral hospital. All head and neck cancer patients in the Southern Health Care region, with a catchment area of approximately 1.2 million inhabitants, are treated at Skåne University Hospital. The patients will be assessed by the study coordinator to be able to follow and complete the intervention.
Recruitmenthttps://register.clinicaltrials.gov/prs/beta/studies/S000EE8A00000009/protocol/conditions?edit=true As part of clinical routine, the patients have a doctor´s visit three months after cancer treatment completion at the Dept. of ORL-HNS Skåne University Hospital, Lund. The assessment of lymphedema will be performed as a part of the clinical examination. Patient who are assessed to have lymphedema (>2 SD of healthy reference values13) and are possible candidates for enrolment will receive oral and written information about the study. If the patient accepts inclusion, a signed consent will be retrieved.
Intervention A: HIT
Highly Intensive Treatment with Self MLD:
Week 1 - 2: 20 strokes at the neck, 20 strokes at the cheek and finally 20 strokes at the neck, at both sides of the neck and face. This treatment should by repeated every two hours during the daytime, approximately 6-8 times a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The person who will do the randomization, the outcome assessor, and the care provider will be blinded.
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
- •• a previous diagnosis of oropharyngeal cancer (all histological types are accepted)
- •curative treatment with (chemo)radiotherapy to at least 68Gy at the primary site completed no more than 1 year before the study inclusion
- •age >18 years
- •ability to give written and informed consent.
排除标准
- •• pregnancy
- •surgery or Botox injections in the tissue of the head and neck area
- •Locoregional deep infection i.e., suspected abscess at the scheduled time points for measurements.
- •prior daily treatment with Self MLD
- •other treatment of head and neck lymphedema, for example compression
- •psychiatric disorders
- •substance abuse problems
结局指标
主要结局
Recruitment rate, retention rate, adverse events, and ability to collect outcomes
时间窗: Two and twelve weeks after inclusion
of recruitment rate, calculated as the percentage of individuals who agreed to be in the study among those who were qualified; retention rate, calculated as the percentage of individuals who completed the intervention; the ability to collect data, calculated as the percentage of completed collected data at baseline and follow-up; and adverse events, which is the num-ber of harmful or negative events that may have influenced the study procedure
次要结局
未报告次要终点
研究者
Eva Ekvall-Hansson
Professor
Lund University