Condition category
Circulatory System
Date applied
08/09/2004
Date assigned
21/09/2004
Last edited
13/07/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.icr.ac.uk/research/research_sections/clinical_trials/clinical_trials_list/2385_disease.shtml

Contact information

Type

Scientific

Primary contact

Prof John Yarnold

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00077090

Protocol/serial number

MREC/04/4/016

Study information

Scientific title

Acronym

HOT

Study hypothesis

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

Not provided at time of registration

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase II

Drug names

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

63

Participant exclusion criteria

Evidence of cancer recurrence.

Recruitment start date

01/01/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cancer Research
London
SW7 3RP
United Kingdom

Sponsor information

Organisation

The Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom
john.yarnold@icr.ac.uk

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Health - excess treatment costs

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20605648

Publication citations

  1. Results

    Gothard L, Haviland J, Bryson P, Laden G, Glover M, Harrison S, Woods M, Cook G, Peckitt C, Pearson A, Somaiah N, Stanton A, Mortimer P, Yarnold J, Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer., Radiother Oncol, 2010, 97, 1, 101-107, doi: 10.1016/j.radonc.2010.04.026.

Additional files

Editorial Notes