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

Completed

• Conditions: Status after operation and radiation for mammary cancer.; Cancer; Breast

• Registration Number: ISRCTN43727802
• Lead Sponsor: Heinrich-Heine-University Düsseldorf (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified