Early Pulmonary Dysfunction in Childhood Cancer Patients
ConditionPulmonary Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-22
SponsorUniversity Children's Hospital Basel
About this trial
This longitudinal, prospective, multicentre study is to monitor lung function prospectively in childhood cancer patients after diagnosis. The impact of cancer treatment on pulmonary dysfunction non-invasively using lung function, lung imaging and breath analysis as well as clinical symptoms using a questionnaire will be assessed at different time points.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
chest radiation
treatment with any kind of chemotherapy
hematopoietic stem cell transplantation (HSCT)
thoracic surgery
Disqualifiers
no signed informed consent
Operation outside the chest area as only cancer treatment
Relapsed cancer (patients who develop relapse during the study will not be excluded)
Subjects who are respiratory insufficient and cannot perform a lung function test (less than 92% O2 saturation; under O2 therapy)
Trial population
Every new diagnosed cancer patient and every cancer patient planned for HSCT who is 4 years or older will be asked by the paediatric oncologist to participate in the study. This study will be conducted at the University Children's Hospital of Basel, Bern, Geneva, Lausanne and Zürich.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Lung function measurements
Diagnostic testAll lung function tests are non-invasive and last about 60 minutes per child: * Multiple Breath Washout: The nitrogen multiple-breath-washout test (N2MBW) measures ventilation inhomogeneity of the lung that occurs when smaller airways are damaged. * Spirometry/Bodyplethysmography/DLCO: Spirometry measures dynamic air flows to quantify airway obstruction of large airways and pulmonary restriction. Plethysmography assesses static lung volumes. Diffusing capacity of the lung for carbon monoxide (DLCO) evaluates diffusion deficits.
Breath Analysis
Diagnostic testPatients will exhale into a secondary electrospray-ionization-mass spectrometry (SESI-MS) breath analysis platform. SESI-MS allows real-time breath-printing by detection of both volatile and non-volatile trace components.
Magnetic resonance imaging (MRI)
Diagnostic testFunctional MRI scan assessing regional fractional lung ventilation and relative perfusion, followed by a morphological MRI scan. This technique allows simultaneous assessment of all affected lung components, the airways, alveoli and pulmonary vasculature.
Standardized interview to assess respiratory symptoms
Other interventionShort questions on current airway symptoms, recent colds, exercise-related respiratory symptoms, and passive smoking exposure will be assessed. The interview takes about 10 minutes.
Data collection for assessment of clinical parameters and cumulative doses to chemotherapy, radiation, surgery and HSCT
Other interventionAssessment of clinical parameters and cumulative doses to chemotherapy, radiation, surgery and hematopoietic stem cell transplantation (HSCT). Data on cumulative doses of pulmotoxic chemotherapy (carmustine, lomustine, busulfan, bleomycin, methotrexate and cyclophosphamide, fludarabine, ifosfamide, melphalan and thiotepa) and radiation therapy at the region of the chest from patient's hospital charts will be collected. Information on chest wall and lung surgery will be retrieved from the surgical reports. Information about conditioning regimens including cumulative chemotherapy doses and total body irradiation of patients undergoing HSCT will be collected. Further information on the health state of the patient and interventions (e.g. development of pneumonia, antibiotic treatment) will be collected from the hospital charts.
Collection of genetic samples
Other interventionGermline DNA is collected (e.g. through saliva or buccal cell sampling) for later analysis on genetic risk factors for pulmonary complications.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in Forced expiratory volume in 1 second (FEV1)
Dynamic lung function parameter: Forced expiratory volume in 1 second (FEV1)
Time frame
At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment2
Change in ratio of FEV1/forced vital capacity (FVC) for airway obstruction
Dynamic lung function parameter: ratio of FEV1/forced vital capacity (FVC) for airway obstruction
Time frame
At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment3
Change in total lung capacity (TLC)
Static lung function parameter: total lung capacity (TLC) to assess lung restriction
Time frame
At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment4
Change in residual volume (RV)/TLC
Static lung function parameter: residual volume (RV)/TLC to assess hyperinflation
Time frame
At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatmentSecondary outcomes
1
Change in 4-hydroxy-2-nonenal in exhaled breath
Breath analysis: 4-hydroxy-2-nonenal is regarded as a surrogate marker for oxidative stress in the human body.
Time frame
At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment2
Change in volatile organic compounds (VOCs) in exhaled breath
Untargeted explorative approach to assess volatile organic compounds (VOCs) in exhaled breath
Time frame
At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment3
Assessment of genetic variants through saliva or buccal cell sampling (collection of germline DNA)
Genetic variants associated with susceptibility to cancer therapy or related to lung development. Assessed in the Germline DNA Biobank Switzerland for childhood cancer and blood disorders (BISKIDS, as part of the Paediatric Biobank for Research in Haematology and Oncology \[BaHOP\], ethics approval PB\_2017-00533 to assess genetic determinants of pulmonary toxicity.
Time frame
At Baseline (start of therapy)Sponsors and contacts
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Source ClinicalTrials.gov