Double-blind randomized placebo-controlled clinical trial for treatment of breast symptoms with hyperbaric oxygen after breast-preserving operation and radiation

ISRCTN	ISRCTN43727802
DOI	https://doi.org/10.1186/ISRCTN43727802
Protocol serial number	01S1_020
Sponsor	Heinrich-Heine-University Düsseldorf (Germany)
Funder	Heinrich-Heine-University Dusseldorf

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Hildegard Pape
Scientific

Klinik für Strahlentherapie und Radioonkologie
Düsseldorf
40225
Germany

Phone	+49 (0)211 8117990
Email	papeh@uni-duesseldorf.de

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	O2-Studie
Study objectives	Comparison of hyperbaric oxygen and placebo.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Status after operation and radiation for mammary cancer.
Intervention	Hyperbaric oxygen versus placebo.
Intervention type	Other
Primary outcome measure(s)	Lent-Soma score (4 months).
Key secondary outcome measure(s)	1. Lent-Soma score (final) 2. EORTC LQ30 plus breast module (4 months, final) 3. Dermal thickness (4 months)
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key 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
Key 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
Date of first enrolment	12/11/2003
Date of final enrolment	31/12/2007

Klinik für Strahlentherapie und Radioonkologie

Düsseldorf
40225
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan