Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter Study Evaluating Quality of Life in Patients With Advanced Malignant Lung Tumors With or Without "add-on" Homeopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- EORTC-QLQ-C30 Score
研究概览
简要总结
The investigators aim to investigate the validity of their previous results in a randomized prospective, placebo-controlled, double-blind, multicenter controlled evaluation of questionnaires in patients with advanced malignant tumors. The investigators plan to compare the treatment outcome (quality of life and survival) in tumor patients, receiving standard or "add-on" homeopathic treatment.
The null hypothesis is that "add-on" homeopathic treatment does not create a benefit for cancer patients. In addition the investigators evaluate survival time.
详细描述
The EORTC-QLQ-C30, SF-36 as well as a VAS scale for subjective well-being will be filled out by the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Informed consent
- •Clinical diagnosis of advanced tumor stages of non small-cell lung carcinoma (NSCLC) IIIB, IIIC, IV.
排除标准
- •sensitizing mutation of the EGFR gene or translocation of the ALK gene
- •refusal to sign informed consent
- •pregnancy
- •hematological, hepatic, or renal pathology
- •coronary heart disease
- •history of secondary tumor
- •major surgery within 4 weeks prior to study entry
- •active infection and symptomatic peripheral neuropathy
- •central nervous system metastases unless the metastases were treated and stable
- •active autoimmune disease
- •use of systemic immunosuppressive treatment
- •use of systemic treatment during the previous 2 years
- •active interstitial lung disease, or a history of pneumonitis for which glucocorticoids were prescribed
- •previous systemic therapy for metastatic disease or previous irradiation
- •use of any complementary and/or alternative therapy, including homeopathy other than the research treatment during the trial
研究组 & 干预措施
Additive homeopathy in cancer patients
Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules
干预措施: Additive classical homeopathy (Drug)
Additive homeopathic placebo globules
Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules
干预措施: Homeopathic Placebo globules (Drug)
结局指标
主要结局
EORTC-QLQ-C30 Score
时间窗: baseline and at 18 weeks
Quality of life was evaluated by using the Global Health Status assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), which was completed by participants throughout the study. The score of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status.
次要结局
- Survival(2 years for the individual patient (=whole study duration))
研究者
Michael Frass
Principal Investigator, Prof. Dr., Director, Outpatient Unit Homeopathy in tumor patients
Medical University of Vienna