Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for early breast cancer (HOT) - HOT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004952-38-GB

Enrollment

Registered

2005-02-23

Start date

2005-02-11

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Chronic radiation-induced arm lymphoedema.

Interventions

Trade Name: Medical oxygen Product Name: Medical oxygen Pharmaceutical Form: Inhalation gas INN or Proposed INN: medical oxygen Concentr

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of the trial is to test the efficacy of hyperbaric oxygen therapy in reducing arm lymphoedema in patients suffering long-term adverse effects of high dose radiotherapy for early breast cancer. ;Secondary Objective: A secondary aim is to test mechanisms of tissue reperfusion and healing in response to hyperbaric oxygen therapy.;Primary end point(s): Volume of the affected limb expressed as a percentage of the contralateral limb volume on the day of measurement.	—

Measure

Time frame

Main Objective: The primary aim of the trial is to test the efficacy of hyperbaric oxygen therapy in reducing arm lymphoedema in patients suffering long-term adverse effects of high dose radiotherapy for early breast cancer. ;Secondary Objective: A secondary aim is to test mechanisms of tissue reperfusion and healing in response to hyperbaric oxygen therapy.;Primary end point(s): Volume of the affected limb expressed as a percentage of the contralateral limb volume on the day of measurement.

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Countries

United Kingdom

Outcome results

None listed

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