Clinical trial NCT01975558: The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study
Official title: The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 34
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty patients with breast cancer. Ten healthy volunteers.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in radiation metabolites
timeFrame: During radiation treatment, expected to be ca. 5 weeks
Secondary outcomes:
measure: New potential biomarkers for radiation biodosimetry
timeFrame: During and after radiation treatment (at baseline, week 1,5 + 6, 8 weeks after therapy end)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Radio-Oncology, Bern University Hospital
Study officials:
affiliation: Dept. of Radiation Oncology, University Hospital, Inselspital Bern
name: Kristina Loessl, MD
role: STUDY_CHAIR
References: