EUCTR2004-004952-38-GB
Active, not recruiting
Phase 1
Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for early breast cancer (HOT) - HOT
Prof John Yarnold, Institute of Cancer Research0 sites63 target enrollmentFebruary 23, 2005
DrugsMedical oxygen
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic radiation-induced arm lymphoedema.
- Sponsor
- Prof John Yarnold, Institute of Cancer Research
- Enrollment
- 63
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Past history of surgery and radiotherapy for early breast cancer including radiotherapy to the axilla and/or SCF at least 24 months prior to trial entry. Arm lymphoedema (at least 15% increase in arm volume). No evidence of cancer recurrence. Physical and psychological fitness for hyperbaric oxygen therapy. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Prior hyperbaric oxygen therapy, claustrophobia, epilepsy. Chronic obstructive airways disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated phneumothorax. Previous ear operations, eustachian tube dysfunction or recurrent attacks of vertigo.
Outcomes
Primary Outcomes
Not specified
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