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Clinical Trials/EUCTR2004-004952-38-GB
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

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.

Registry
who.int
Start Date
February 23, 2005
End Date
December 31, 2008
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Prof John Yarnold, Institute of Cancer Research

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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