advanced breast cancer in female patients or advanced non-small cell lung cancer (NSCLC) in female or male patients during oncological standard therapy
Conditions
Interventions
Trade Name: Helixor® P 100 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Kiefernmistel-Auszug
CAS Number: 8001000-56-4
Other descriptive name: VISCUM ALBUM
Concentration unit: mg
Sponsors
Helixor Heilmittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): change of sum score of cancer-related fatigue (CrF) during three months of treatment with trial medication ;Timepoint(s) of evaluation of this end point: sumscore of CrF will be determined at the beginning and after 2 weeks, 5 weeks and 3 months of treatment with trial medication;Main Objective: Assessment of the influence of an administration of Helixor® P as an intravenous infusion on Cancer-related Fatigue (CrF, measured as total fatigue score) of patients with advanced breast cancer or advanced NSCLC during oncological standard therapy;Secondary Objective: Study objectives during treatment with trial medication: Assessment of the influence of an administration of Helixor® P as an intravenous infusion during oncological standard therapy on - different subscales of CrF - VAS-E score of CrF - general quality of life - Karnofsky Performance Index - functionality of mitochondria in PBMC - response rate of primary disease on oncological standard therapy in patients with advanced breast cancer or advanced NSCLC Evaluation of a possible connection between change in functionality of mitochondria in PBMC and change of CrF (total fatigue score and subscales of CrF) study objectives during follow up: Assessment of change of following parameters during an observation period of three months after termination of treatment with trial medication - total fatigue scale and subscales of CrF - CrF score as determined by use of VAS-E - general quality of life - Karnofsky Performance Index (KPI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): change of the following parameters during three months of treatment with trial medication • subscales of CrF • VAS-E score • general quality of life • Karnofsky Performance Index (KPI) • mitochondrial function determination of the following parameters during three months of treatment with trial medication • tumor response • tolerability change of the following parameters during three months of follow up observation after end of treatment with trial medication • sum score of CrF • subscales of CrF • general quality of life (QoL) • Karnofsky Performance Index (KPI) determination of tumour response during three months of follow up observation after end of treatment with trial medication (if not yet assessible at the end of treatment with trial medication) Further explorative study objectives only: • assessment of the influence of an administration of Helixor® P as an intravenous infusion during an oncological standard therapy on the functionality of mitochondria in PBMC in patients with advanced breast cancer or NSCLC. • assessment of the relationship between the change of functionality of mitochondria in PBMC and the change of CRF (total fatigue score and subscales). ;Timepoint(s) of evaluation of this end point: Following timepoints are planned: - sumscore of CrF: end of follow up only (3 months after end of treatment with trial medication) - subscales of CrF: at the beginning and after 2 weeks, 5 weeks and 3 months of treatment with trial mediation as well as at the end of follow up - general QoL: at the beginning and after 2 weeks, 5 weeks and 3 months of treatment with trial mediation as well as at the end of follow up - KPI: at the beginning, thereafter weekly until end of treatment with trial medication as well as at the end of follow up - mitochondrial function: at the beginning and after 2 weeks, 5 weeks and 3 months of treatment with trial medication - tumor response: assessment acc. to standard rules for | — |
Countries
Germany
Contacts
Public ContactSabine Rieger
Helixor Heilmittel GmbH
Outcome results
None listed