EUCTR2018-001596-20-DE进行中（未招募）1 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-2018
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 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 +/- concomitant targeted therapy(ies) 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 or 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 g/dl
- •- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
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, convulsive equivalents or other neurological symptoms
- •- other cancer disease requiring Treatment (other than complaints that are clearly related to primary disease such as malignant pleural effusion or ascites
- •- 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
- •- Urgent suspicion of allergy to mistletoe preparations via detection of anti-mistletoe lectin antibodies of the IgE type
- •- 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
- •- 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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