Supportive Helixor® therapy for advanced tumor diseases of the mammary gland and gynecological and gastrointestinal organs

Supportive Helixor® therapy for advanced tumor diseases of the mammary gland and gynecological and gastrointestinal organs - HelixAn

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036181

Enrollment

100

Registered

2025-02-14

Start date

2025-06-03

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50 C51-C58 C15-C26

Interventions

Group 1: As part of this observational study, routine treatment data is recorded and analyzed at four points of observation (PO 1: after the decision for and before the first administration of Helixor

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Advanced tumor diseases of the mammary gland, gynaecological organs, or gastrointestinal organs (stage IV, M1). - New start of Helixor® therapy. In the case of previous mistletoe therapy, this must have been completed before the first point of observation.

Exclusion criteria

Exclusion criteria: - Other than subcutaneous application of mistletoe preparations (e.g. intravenous infusions). - Contraindication for Helixor® therapy.

Design outcomes

Primary

Measure	Time frame
Influence of a newly started Helixor® therapy on tumor fatigue (measured with CFS-D questionnaire)	—

Secondary

Measure	Time frame
Several: - Influence of a newly started Helixor® therapy on the general quality of life under the practice conditions of outpatient oncological care (measured with the FACT-G questionnaire and Karnofsky Performance Index / KPI). - Influence of a newly started Helixor® therapy on the level of body temperature and circadian temperature regulation, as well as on the subjective sensation of warmth (recorded by sublingual temperature measurement and questions in the therapy diary). - Determination of the implementation and feasibility of Helixor® therapy under practical conditions (documentation of practical application). - Tolerability of Helixor® therapy (documentation of side effects with calculation of frequency and analysis of suspected cases of unexpected side effects). - Determination of differences in the above-mentioned primary and secondary parameters depending on the standard oncological therapies carried out or the tumor entity affected (analysis of subgroups).	—

Measure

Time frame

Several: - Influence of a newly started Helixor® therapy on the general quality of life under the practice conditions of outpatient oncological care (measured with the FACT-G questionnaire and Karnofsky Performance Index / KPI). - Influence of a newly started Helixor® therapy on the level of body temperature and circadian temperature regulation, as well as on the subjective sensation of warmth (recorded by sublingual temperature measurement and questions in the therapy diary). - Determination of the implementation and feasibility of Helixor® therapy under practical conditions (documentation of practical application). - Tolerability of Helixor® therapy (documentation of side effects with calculation of frequency and analysis of suspected cases of unexpected side effects). - Determination of differences in the above-mentioned primary and secondary parameters depending on the standard oncological therapies carried out or the tumor entity affected (analysis of subgroups).

—

Countries

Germany

Contacts

Public ContactKlinische Forschung

Helixor Heilmittel GmbH

Klifo@helixor.de+497428935850

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026