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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975558
• Other study ID #: 181/11
• Status: Completed
• Start date: June 26, 2014
• Est. completion date: November 12, 2019

Study information

• Verified date: February 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

Radiotherapy: cancer treatment with total doses of more than 30 Gy, single fraction dose of at least 1.8 Gy/die. Big treatment/target volume. Age over 50 years, according to postmenopausal status. No simultaneous chemotherapy in breast cancer patients. For the control group: healthy volunteers (women), age over 50 years, according to postmenopausal status; no previous chemo - and cancer therapy.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Biological:
• Sampling at baseline, one week after baseline, two weeks after baseline

• Sampling at baseline, during radiotherapy and after

Locations

Country	Name	City	State
Switzerland	Department of Radio-Oncology, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in radiation metabolites	To affirm the results from animal model in radiation metabolomics in human radiotherapy treatment.	During radiation treatment, expected to be ca. 5 weeks
Secondary	New potential biomarkers for radiation biodosimetry	To find new potential biomarkers for radiation biodosimetry in humans and to identify changes in different sequences in measuring from local and systemic material.	During and after radiation treatment (at baseline, week 1,5 + 6, 8 weeks after therapy end)

External Links

•   List of activated trials or trials in progress at the University Clinic of Radio-Oncology, Inselspital Berne