Prospective Controlled Randomized Feasibility Study on a Treatment With Viscum Album in Patients With Breast Cancer to Identify Appropriate Surrogate Parameters for a Randomized Study of the Efficacy of Treatment With Mistletoe Extracts
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- anxiety and depression
研究概览
简要总结
The purpose of this feasibility study is to identify appropriate surrogate parameters for a randomized study to examine the efficacy of a complementary therapy with an extract of viscum album (Iscador P) in patients with breast cancer.
详细描述
The study consists of three parts. Part 1 is a prospective non-randomized feasibility study in patients with breast cancer after primary surgery during chemotherapy or endocrine therapy comparing blood count, lymphocytes, quality of life and local and general side effects between the groups Part 2 is a prospective randomized feasibility study with a waiting list for three months comparing changes in quality of life, depression, diurnal cortisol profile and expression of zeta-chains in T- and NK-cells after three months of treatment or waiting in patients of two different strata (early breast cancer UICC I/II and metastatic breast cancer) Part 3 consists of two follow-up periods of 12 months respective. Patients may choose to continue, quit or restart mistletoe treatment upon their own decision, endpoints from part 2 are evaluated every 6 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer
- •desire for additional therapy with mistletoe extracts
排除标准
- •contraindication for a therapy with mistletoe extracts(allergy, tuberculosis, hyperthyreosis, acute infectious disease, intracranial pressure in case of tumors or metastasis)
- •current medication with glucocorticoids or other immunosuppressive therapies
- •other concomitant complementary therapies
- •prior therapy with mistletoe extracts > 2 years or during the last 6 months
- •karnofsky-Index <60
研究组 & 干预措施
viscum album pini
immediate start of treatment with Iscador P s.c.
干预措施: viscum album pini (Drug)
waiting group
identical treatment with Iscador P s.c. after waiting period of 3 months
干预措施: viscum album pini (Drug)
结局指标
主要结局
anxiety and depression
时间窗: 6-30 months
blood count
时间窗: 6-30 months
quality of life
时间窗: 6-30 months
lymphocytes
时间窗: 6-30 months
lymphocyte stimulation
时间窗: 4 months
diurnal profile of cortisol
时间窗: 6-30 months
expression of zeta-chains on T- and NK-cells
时间窗: 6-30 months
次要结局
- documentation of concomitant medication(6-30 months)
- local reactions(6-30 months)
- documentation of concomitant therapies(6-30 months)
研究者
Cornelia von Hagens
Head Complementary & Integrative Medicine, Dep. 4.2
Heidelberg University