Prospective Surveillance for Breast Cancer-Related Lymphedema: A Randomized Trial
概览
- 阶段
- 不适用
- 干预措施
- Prospective surveillance
- 疾病 / 适应症
- Breast Cancer
- 发起方
- Rigshospitalet, Denmark
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Prevalence of chronic lymphedema
- 状态
- 进行中（未招募）
- 最后更新
- 19天前
概览
简要总结
This randomized trial will test the effect of a prospective surveillance program for early detection and subclinical management of breast cancer-related lymphedema on the prevalence of chronic lymphedema.
详细描述
Design and setting: This trial is a multi-center single-blind trial involving five hospitals in Denmark. Procedure: All women booked for surgery for breast cancer at one of the study sites will be invited to participate. Women, who provide written informed consent, will have BIS measurements, and perform self-measurements of arm circumference. Further, participants will complete a sociodemographic questionnaire which will be used to ensure recruitment of a representable sample. This data will be collected at the hospital of surgery at pre-treatment. After surgery, women who had \>6 lymph nodes removed and have planned radiation therapy will be randomized 1:1 into intervention or control.
研究者
入排标准
入选标准
- •≥18 years;
- •surgery for breast cancer (unilateral and bilateral) including ALDN with \>6 lymph nodes removed;
- •can effectively communicate verbally in Danish;
排除标准
- •surgery for breast cancer with SLNB or \< 6 nodes removed;
- •pre-existing lymphedema (primary or secondary);
- •previous treatment for breast cancer;
- •pace maker;
- •conditions known to cause swelling (pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis or deep vein thrombosis in the arms).
研究组 & 干预措施
Intervention (INT)
INT participants will be asked to perform self-measurements of arm circumference at five points along the arm at home every three months. Additional measurements can be performed if the participants experience signs of BCRL. Participants will report the self-measurements in cm and mm in an online questionnaire, or over the phone to a physiotherapist navigator, along with reporting sign and symptoms of BCRL.
干预措施: Prospective surveillance
Control (CON)
The CON group will follow the usual post-operative care. CON participants will be prompted every 6 months by an online questionnaire to report if they have been diagnosed with BCRL and if so, month of initiation of treatment.
结局指标
主要结局
Prevalence of chronic lymphedema
时间窗: At 24 months post-surgery
A binary outcome (y/n) defined as BIS ≥10 from pre-surgery or outside normal range ±10
次要结局
- Time-to-treatment(INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery)
- Health-related quality of life(pre-treatment, 6, 12, 18 and 24 months post-surgery)
- Arm function(pre-treatment, 6, 12, 18 and 24 months post-surgery)