DRKS00016937进行中（未招募）2 期
Influence of a Helixor® P infusion therapy on the Cancer-related Fatigue (CrF) of female patients with advanced breast cancer or female or male patients with NSCLC during oncological standard therapy - a pilot study - HelPIT-730-163-2018
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Advanced breast cancer (incurable, e.g. inoperable primary tumor, inoperable relapse and/or metastases) with planned palliative chemotherapy with or without concomitant targeted therapy(s) or therapy with CDK4/6 inhibitors and hormone therapy
- •advanced non-small cell lung cancer (incurable, e.g. inoperable primary tumor, inoperable relapse and/or metastases) with planned palliative combination therapy CPI + chemotherapy
- •advanced NSCLC (incurable, e.B. inoperable primary tumor, inoperable recurrence and/or metastases) with planned monotherapy with CPI or TKI
- •legal capacity
- •capacity to understand nature and scope of clinical trial and to follow the instructions of investigator
- •caucasian
- •age = 18 years
- •personally signed and dated informed consent after oral and written information about risk and benefit of clinical trial
- •sex: female (breast cancer) resp. female or male (non-small cell lung cancer)
- •estimated life expectancy of at least 9 months
- •Karnofsky Performance Index = 50 %
- •VAS-E score value < 61
- •sufficient bone marrow function, defined as leucocytes > 3,0 GPT/l; neutrophils = 1,5 GPT/l, thrombocytes > 100 GPT/l; hemoglobin > 9
- •sufficient kidney function (serum creatinine = 1,2 x of upper limit of normal range)
- •a negative pregnancy test has to be provided for female premenopausal patients before study entry
- •written agreement of female premenopausal patients to apply an active birth-control method
排除标准
- •pregnancy
- •breast-feeding
- •manifest brain metastases with current inflammatory problems such as increased or increasing brain pressure or cerebral pressure signs, such as headaches, dizziness, visual disturbances, convulsion supcoths or other new-rological symptoms
- •other cancer disease requiring treatment (except for ailments that are clearly related to primary disease such as malignant pleural effusion or ascite)
- •immunosuppressive treatment after organ transplantation
- •comorbidity with one of the following:
- •- severe allergic diseases (including severe asthma bronchiale)
- •- acute inflammatory or highly febrile diseases (control of CRP value)
- •- persistent infection
- •- severe systemic diseases as multiple sclerosis
- •- hyperthyroidism with tachycardia
- •- autoimmune diseases as well as chronic inflammatory bowel diseases
- •- chronic granulomatous diseases e.g. tuberculosis, Crohn's disease or sarcoidosis
- •- hyperhydration
- •- hypokalemia, hypernatremia or hyperchloremia
- •- diseases which demand a strict sodium intake (cardiac insufficiency, hypertension, generalised edemas, pulmonary edema, eclampsia, serious renal insufficiency)
- •- other concomitant diseases likely to affect the significance of clinical trial
- •pretreatment with mistletoe products (anamnestic history or verified by positive antibody test on anti-mistletoe lectin-antibodies (test on IgG total and IgE))
- •planned treatment with trial medication by different route of administration (subcutanous injection or others) or with another mistletoe product
- •concurrent or planned radiotherapy within the next 3 months including irradiation of manifest brain metastases
- •therapy before or at the same time with thymus, Factor AF2 or other immunstimulating therapies (except therapy with immune-checkpoint-inhibitor)
- •abuse of legal or illegal drugs or severe abuse of alcohol
- •participation in a further clinical trial
- •subjects which are in a state of dependence in relation to the sponsor's or investigator's institutions or which are their employees
研究者
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