Effects of proton beam therapy on blood coagulation in patients with malignant head and neck cancer: A monocentric exploratory study

Effects of proton beam therapy on blood coagulation in patients with malignant head and neck cancer: A monocentric exploratory study - ProThrom

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036481

Enrollment

Registered

2025-07-07

Start date

2025-10-17

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

malignant head and neck tumors in adult

Interventions

Group 1: Adult patients with malignant head and neck tumors receiving proton therapy will be examined at five time points during therapy for changes in blood coagulation. • A thrombosis and bleeding

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: o Age = 18 years at the start of proton therapy o Diagnosis of a malignant head and neck tumor o PT at the WPE with justifying indication and consent for PT targeting the primary tumor and the bilateral/ipsilateral lymphatic drainage pathways o Participation in the WPE adult registry study (ProReg) with corresponding consent (12-5143-BO, ethics vote 21.08.2012) o Signed declaration of consent for the study

Exclusion criteria

Exclusion criteria: o Age under 18 years o Adjuvant radiotherapy concept o Previous partial or complete neck dissection with removal of the internal jugular vein in the radiation area (surgery) o Ongoing anticoagulation therapy o Known thrombocytopathy o Severe anemia with signs of ischemia o Hormonal contraception o No written consent for the WPE registry and the prospective study

Design outcomes

Primary

Measure	Time frame
Change in the concentration of clotting factors and clotting time (CT) of native blood (NATEM). The clotting time is analyzed by thrombelastometry (ROTEM®). All examinations take place 60 minutes before and 60 minutes after the first proton radiation session, as well as in the 1st, 4th and 7th week of radiation.	—

Secondary

Measure	Time frame
Change in clot firmness, the so-called average maximum clot firmness (MCF) and the intrinsic lysis potential, the so-called clot lysis (CL) of native blood 60 minutes before and 60 minutes after the first proton beam session, as well as in the 1st, 4th and 7th week of irradiation.	—

Countries

Germany

Contacts

Public ContactHeike Thomas

Westdeutsches Protonentherapiezentrum Essen (WPE), Universitätsklinikum Essen

heike.thomas@uk-essen.de+49 201 723 6606

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026