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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43727802

Enrollment

Registered

2005-10-28

Start date

2003-11-12

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Status after operation and radiation for mammary cancer. Cancer Breast

Interventions

Hyperbaric oxygen versus placebo.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Lent-Soma score (4 months).	—

Secondary

Measure	Time frame
1. Lent-Soma score (final) 2. EORTC LQ30 plus breast module (4 months, final) 3. Dermal thickness (4 months)	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026