Plain English Summary
Not provided at time of registration
Trial website
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
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
-
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.