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 lung cancer (Non small cell lung cancer) during common cancer treatment - a pilot study

Phase 1

• Conditions: advanced breast cancer in female patients or advanced non-small cell lung cancer (NSCLC) in female or male patients during oncological standard therapy; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001596-20-DE
• Lead Sponsor: Helixor Heilmittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-02
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 144

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 < 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified