The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study

Completed

• Conditions: Breast Cancer
• Interventions: Biological: Sampling at baseline, during radiotherapy and after; Biological: Sampling at baseline, one week after baseline, two weeks after baseline

• Registration Number: NCT01975558
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic profile in the exposed area and/or systemically and specific radiation biomarkers can be identified in the respective matrices.

Purpose: This is a pilot study to verify in humans the results obtained from two animal models exposed to ionizing gamma-radiation. The classification of patients results from the treatment volume of radiotherapy for cancer disease. Two patient groups with breast cancer undergoing high-dose radiotherapy are selected and compared to control group of age matched healthy women.

Detailed Description

Background

Humans are exposed to ionizing radiation from several sources. Gamma-radiation exposure induces thereby both short- and long-term adverse effects. The radiation injuries to be expected in humans in the acute stage (days to some weeks after radiation exposure) correlate with the radiation dose that the individual has received. With very high doses gastrointestinal syndrome leads to death within a few days. The survival of the individual in the acute stage is therefore dramatically dependent on the rapid application of suitable therapies. It is decisive here to identify in the shortest possible time those persons who have been exposed to a critical radiation dose and to estimate the dose received in order to apply an adequate therapy. There are no satisfying test methods available today, which would enable the mass screening for radiation injury.

Furthermore to identify changes in the local or systemic human metabolic fingerprint, which are useful for the prediction of the individual sensitivity of patients to radiotherapy and / or lead to a better understanding of the molecular mechanisms involved in radiotherapy.

Objective

Primary: The primary endpoint is to affirm the results from the animal model in radiation metabolomics in human radiotherapy treatment.

Secondary: The secondary endpoints are to find new potential biomarkers for radiation biodosimetry in humans and to identify changes in the different sequences in measuring from local (sebum) and systemic (blood, saliva and urine) material.

Methods

Gas chromatographic separation and mass spectrometric detection of the metabolites present in a given matrix (urine, saliva, plasma, sebum).

Study Timeline

• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Study Start: 2014-06-26
• Primary Completion: 2019-11-12
• Study Completion: 2019-11-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer B	Sampling at baseline, during radiotherapy and after	Breast cancer (60 Gy). The group will undergo blood, urine, sebum, and saliva sampling within the irradiation field.
Control group A	Sampling at baseline, one week after baseline, two weeks after baseline	Control group. The group will undergo blood, urine, sebum, and saliva sampling.
Breast cancer C	Sampling at baseline, during radiotherapy and after	Breast cancer (60 Gy). The group will undergo blood, urine, sebum, and saliva sampling outside of the irradiation field, e.g. at the arm.

Primary Outcome Measures

Name	Time	Method
Change from baseline in radiation metabolites	During radiation treatment, expected to be ca. 5 weeks	To affirm the results from animal model in radiation metabolomics in human radiotherapy treatment.

Secondary Outcome Measures

Name	Time	Method
New potential biomarkers for radiation biodosimetry	During and after radiation treatment (at baseline, week 1,5 + 6, 8 weeks after therapy end)	To find new potential biomarkers for radiation biodosimetry in humans and to identify changes in different sequences in measuring from local and systemic material.

Trial Locations

Locations (1)

Department of Radio-Oncology, Bern University Hospital; 🇨🇭 Bern, Switzerland