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
- Conditions
- C50C34Malignant neoplasm of breastMalignant neoplasm of bronchus and lung
- Registration Number
- DRKS00016937
- Lead Sponsor
- Helixor Heilmittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 8
• 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
or
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
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
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
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of cancer-related fatigue (sum score) during three months of treatment with trial medication.
- Secondary Outcome Measures
Name Time Method Change of the following parameters during three months of treatment with trial medication<br>• CrF (subscales for physical, cognitive and affective fatigue of CFSD, VAS-E score)<br>• general quality of life<br>• Karnofsky Performance Index (KPI)<br>• mitochondrial function<br>• tumor response<br>• tolerability<br>change of the following parameters during three months of follow up observation after end of treatment with trial medication<br>• sum score of cancer-related fatigue<br>• subscales of cancer-related fatigue<br>• general quality of life (QoL)<br>• Karnofsky Performance Index (KPI)<br>• tumour response (if not yet assessible at the end of treatment with trial medication)<br>