Condition category
Cancer
Date applied
09/09/2005
Date assigned
28/10/2005
Last edited
24/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.kksd.de

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

Publication citations

Additional files

Editorial Notes