Phenomena During Proton Therapy: A Prospective Study

Phenomena During Proton Therapy: A Prospective Study - SensPro

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036114

Enrollment

100

Registered

2025-02-18

Start date

2025-03-13

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

Patients with a tumor in the head and neck region

Interventions

Group 1: Prospective study of all patients receiving proton therapy in the head and neck region at the West German Proton Therapy Center in Essen during the observation period. These patients will be

Eligibility

Sex/Gender

All

Age

6 Years to No maximum

Inclusion criteria

Inclusion criteria: - Participation in the internal WPE registries KiProReg (13-5544-BO) and ProReg (12-5143-BO) with corresponding consent - Signed informed consent for the study - Sufficient oral and written proficiency in German or English

Exclusion criteria

Exclusion criteria: - Age: under 6 years - No written consent for the WPE registry and the prospective study - Radiation treatment for distant metastases - Radiation therapy under anesthesia - Radiation in the "eye-line"

Design outcomes

Primary

Measure	Time frame
Perception of sensory phenomena during proton therapy using a self-designed questionnaire, which is distributed to patients twice a week, discussed in a personal interview once a week, and further specified once a week using a counter for precise classification. Additionally, a smell and reaction test is conducted before the start of radiation therapy. The questionnaire aims to capture the characteristics of olfactory and visual perceptions. This includes the time of first occurrence, frequency, and duration, as well as the type and intensity of the olfactory impression. For visual sensations, frequency, duration, intensity, color, shape, and potential changes will be recorded. These characteristics will be documented in relation to the radiation field. To assess these target parameters, a questionnaire will be developed to systematically collect this data, which will be handed out to the patients. Subsequently, a correlation with the stored radiation treatment plans will be established.	—

Measure

Time frame

Perception of sensory phenomena during proton therapy using a self-designed questionnaire, which is distributed to patients twice a week, discussed in a personal interview once a week, and further specified once a week using a counter for precise classification. Additionally, a smell and reaction test is conducted before the start of radiation therapy. The questionnaire aims to capture the characteristics of olfactory and visual perceptions. This includes the time of first occurrence, frequency, and duration, as well as the type and intensity of the olfactory impression. For visual sensations, frequency, duration, intensity, color, shape, and potential changes will be recorded. These characteristics will be documented in relation to the radiation field. To assess these target parameters, a questionnaire will be developed to systematically collect this data, which will be handed out to the patients. Subsequently, a correlation with the stored radiation treatment plans will be established.

—

Countries

Germany

Contacts

Public ContactHeike Thomas

Westdeutsches Protonentherapiezentrum Essen

heike.thomas@uk-essen.de+49 201 7236606

Outcome results

None listed

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