Contact information
Type
Scientific
Primary contact
Prof Hildegard Pape
ORCID ID
Contact details
Klinik für Strahlentherapie und Radioonkologie
Düsseldorf
40225
Germany
+49 (0)211 8117990
papeh@uni-duesseldorf.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01S1_020
Study information
Scientific title
Acronym
O2-Studie
Study hypothesis
Comparison of hyperbaric oxygen and placebo.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Status after operation and radiation for mammary cancer.
Intervention
Hyperbaric oxygen versus placebo.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Lent-Soma score (4 months).
Secondary outcome measures
1. Lent-Soma score (final)
2. EORTC LQ30 plus breast module (4 months, final)
3. Dermal thickness (4 months)
Overall trial start date
12/11/2003
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Invasive mammary cancer
2. Breast-preserving treatment and post-radiation (finalized at least 12 months before)
3. Lent-Soma score ≥8 and or pain grade III
4. Age ≥18
5. Informed consent
6. Last chemotherapy before at least 6 weeks
7. Normal electrocardiogram (ECG)
8. Normal thorax X-ray
9. Normal lung function
10. Normal ear drum findings and tubal patency
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Untreated valvular pneumothorax
2. Relevant obstructive ventilation disorders
3. Decompensated heart insufficiency
4. Metastases
5. Pretreatment with bleomycin
6. Relevant intrapulmonal focal findings
7. Relevant thoracic injuries
8. Pregnancy
9. Relevant psychiatric diseases
10. Non-controllable claustrophobic reactions
11. Spastic disorders
12. Acute febrile diseases
13. Drug and alcohol abuse
Recruitment start date
12/11/2003
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Klinik für Strahlentherapie und Radioonkologie
Düsseldorf
40225
Germany
Sponsor information
Organisation
Heinrich-Heine-University Düsseldorf (Germany)
Sponsor details
Düsseldorf
40225
Germany
+49 (0)211 8119700
ohmannch@uni-duesseldorf.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Heinrich-Heine-University Dusseldorf
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary