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 |
| Secondary identifying numbers | 01S1_020 |
- Submission date
- 09/09/2005
- Registration date
- 28/10/2005
- Last edited
- 24/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Prof Hildegard Pape
Scientific
Scientific
Klinik für Strahlentherapie und Radioonkologie
Düsseldorf
40225
Germany
| Phone | +49 (0)211 8117990 |
|---|---|
| papeh@uni-duesseldorf.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 12/11/2003 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinik für Strahlentherapie und Radioonkologie
Düsseldorf
40225
Germany
40225
Germany
Sponsor information
Heinrich-Heine-University Düsseldorf (Germany)
University/education
University/education
Düsseldorf
40225
Germany
| Phone | +49 (0)211 8119700 |
|---|---|
| ohmannch@uni-duesseldorf.de | |
| Website | http://www.kksd.de |
"ROR" |
https://ror.org/024z2rq82 |
Funders
Funder type
University/education
Heinrich-Heine-University Dusseldorf
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
