Randomised phase II trial of Hyperbaric Oxygen Therapy in patients with chronic arm lymphoedema after radiotherapy for early breast cancer

ISRCTN	ISRCTN00743708
DOI	https://doi.org/10.1186/ISRCTN00743708
ClinicalTrials.gov number	NCT00077090
Secondary identifying numbers	MREC/04/4/016

Submission date: 08/09/2004
Registration date: 21/09/2004
Last edited: 20/01/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof John Yarnold
Scientific

Institute of Cancer Research
123 Old Brompton Road
London
SW7 3RP
United Kingdom

Study information

Study design	Randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Randomised phase II trial of Hyperbaric Oxygen Therapy in patients with chronic arm lymphoedema after radiotherapy for early breast cancer
Study acronym	HOT
Study objectives	Added 06/08/09: The primary aim is to test the efficacy of hyperbaric oxygen (HBO) therapy in reducing arm lymphoedema in patients suffering long-term adverse effects of high dose radiotherapy for early breast cancer. The secondary aim is to test mechanisms of tissue reperfusion and healing in response to hyperbaric oxygen (HBO) therapy. As of 06/08/09 this record has been extensively updated. All updates can be found under the relevant field with the above update date.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic radiation-induced arm lymphoedema.
Intervention	Treatment group: Patients are compressed to 2.4 Atmospheres Absolute (ATA) while sitting in a multiplace hyperbaric chamber. Patients breathe 100% oxygen at pressure via a transparent hood. The total time at 2.4 ATA is 90 minutes. Each participant will receive a total of 30 pressure exposures (5 days per week for 6 weeks). Control group: Patients continue treatment according to best standard management as defined by the trial protocol.
Intervention type	Other
Primary outcome measure	Added 06/08/09: Volume of the affected limb, expressed as a percentage of the contralateral limb Volume on the day of measurement, as measured by perometer 12 months after baseline assessment
Secondary outcome measures	Added 06/08/09: 1. Patient self-assessments, using specific quality of life scale in upper limb lymphoedema and the UK SF-36 Health Survey Questionnaire, at 3, 6, 9 and 12 months after baseline assessment 2. 99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment 3. Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment
Overall study start date	01/01/2006
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	63
Total final enrolment	58
Key inclusion criteria	1. Cancer patients with a past history of breast surgery +/- axillary dissection. 2. Past history of radiotherapy to the breast/chest wall +/- axilla and/or supraclavicular fossa (SCF) (at least 2 years prior to trial entry). 3. At least 15% increase in arm volume (compared to the contralateral arm). 4. Physical and psychological fitness for hyperbaric oxygen therapy.
Key exclusion criteria	Evidence of cancer recurrence.
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Cancer Research

London
SW7 3RP
United Kingdom

Sponsor information

The Institute of Cancer Research (UK)
Research organisation

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Email	john.yarnold@icr.ac.uk
Website	http://www.icr.ac.uk/
"ROR"	https://ror.org/043jzw605

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (C181/A4552) - research costs

No information available

Department of Health - excess treatment costs

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2010		Yes	No
Plain English results			20/01/2022	No	Yes

Editorial Notes

20/01/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.