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Trial registered on ANZCTR


Registration number
ACTRN12612000084886
Ethics application status
Approved
Date submitted
4/01/2012
Date registered
17/01/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Hyperbaric Oxygen Therapy for Radiation Induced Xerostomia (Dry Mouth)
Scientific title
Hyperbaric oxygen therapy versus control to assess affect on quality of life and saliva analysis in patients with established xerostomia following radiotherapy in head and neck cancer.
Secondary ID [1] 279741 0
Nil
Universal Trial Number (UTN)
U1111-1126-8018
Trial acronym
HOTRIX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft tissue radiation injury to salivary glands (xerostomia) 285475 0
Head and Neck Cancer 285598 0
Condition category
Condition code
Cancer 285656 285656 0 0
Head and neck
Oral and Gastrointestinal 285786 285786 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hyperbaric oxygen therapy at 2.4 ATA for 30 treatments.
Each treatment is 90 mins, daily (Mon-Fri) for 6 weeks.This would be at least 6 months after completion of radiotherapy.The treatment is given in a monoplace hyperbaric chamber so no hoods/ masks are required.
Intervention code [1] 283943 0
Treatment: Drugs
Intervention code [2] 284046 0
Treatment: Other
Comparator / control treatment
normobaric air at 1.1 ATA for 30 treatments
Control group
Placebo

Outcomes
Primary outcome [1] 286206 0
Quality of life score with XQ scoring system
Timepoint [1] 286206 0
baseline
end of hyperbaric oxygen treatment
3 months
6 months
12 months
Secondary outcome [1] 295386 0
saliva anlaysis ( pH, flow and consistency). This is tested with a dental kit which allows scoring of saliva flow. The subject need only give a spit sample which is timed over a couple of minutes.
Timepoint [1] 295386 0
prior to hyperbaric oxygen treatment
immediately after hyperbaric oxygen treatment
3 months post hyperbaric oxygen treatment
Secondary outcome [2] 295387 0
bacterial genomic study of saliva
Timepoint [2] 295387 0
baseline
end of treatment
3 months
Secondary outcome [3] 295388 0
Dental extraction rate as reported by subject in a diary which is issued to them at commencement of enrolment.
Timepoint [3] 295388 0
3 months
6 months
12 months
Secondary outcome [4] 295389 0
Participants self report costs as estimated by them in a diary e.g transport to hospital for appointments,saliva analogues, dental visits, speech pathology appointments.
Timepoint [4] 295389 0
6 months

Eligibility
Key inclusion criteria
head and neck cancer with radiation therapy>50Gy
established xerostomia of at least 6 months duration
no contraindiations to hyperbaric oxygen therapy
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to hyperbaric therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is achieved with sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequencing of patients into control and intervention groups will be generated using a computer algorithm to generate a random sequence. This will be done with the help of the biostatistician at QIMR.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients in control group will be offerred the treatment after the 3 month assessmnet as requested by our HREC due to the long time frame of the treatment.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
19/06/2012
Actual
24/04/2012
Date of last participant enrolment
Anticipated
Actual
27/03/2013
Date of last data collection
Anticipated
2/06/2014
Actual
4/07/2016
Sample size
Target
60
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 284443 0
Charities/Societies/Foundations
Name [1] 284443 0
RBWH Research Trust
Country [1] 284443 0
Australia
Primary sponsor type
Individual
Name
Dr S Sherlock
Address
Hyperbaric Medicine Service
RBWH
Butterfield St
Herston
Qld 4029
Country
Australia
Secondary sponsor category [1] 283365 0
Individual
Name [1] 283365 0
Dr Robert Webb
Address [1] 283365 0
Director of Hyperbaric Medicne Service
RBWH
Butterfield St
Herston
Qld 4029
Country [1] 283365 0
Australia
Other collaborator category [1] 260414 0
Individual
Name [1] 260414 0
Dr Graham Dickie
Address [1] 260414 0
Royal Brisbane and womens hospital
Butterfeild st
Herston
State: QLD
Postcode: 4029
Country: Australia
Country [1] 260414 0
Australia
Other collaborator category [2] 260418 0
Individual
Name [2] 260418 0
Dr Alan Bourke
Address [2] 260418 0
Royal Brisbane and womens hospital
Butterfield st
Herston
State: QLD
Postcode: 4029
Country: Australia
Country [2] 260418 0
Australia
Other collaborator category [3] 260419 0
Individual
Name [3] 260419 0
DR Caroline Acton
Address [3] 260419 0
Royal Brisbane and womens hospital
Butterfield st
Herston
State: QLD
Postcode: 4029
Country: Australia
Country [3] 260419 0
Australia
Other collaborator category [4] 260420 0
Individual
Name [4] 260420 0
Ms Lee Jones
Address [4] 260420 0
QIMR
300 Herston Rd
Herston
Qld 4029
Country [4] 260420 0
Australia
Other collaborator category [5] 260421 0
Individual
Name [5] 260421 0
Assoc Prof David Reid
Address [5] 260421 0
QIMR
300 Herston Rd
Herston
Qld 4029
Country [5] 260421 0
Australia
Other collaborator category [6] 260422 0
Individual
Name [6] 260422 0
Mr David King
Address [6] 260422 0
Royal Brisbane and womens hospital
Butterfield St
Herston
State: QLD
Postcode: 4029
Country: Australia
Country [6] 260422 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286419 0
RBWH HREC
Ethics committee address [1] 286419 0
RBWH
Butterfield St
Herston
Brisbane
QLD 4029
Ethics committee country [1] 286419 0
Australia
Date submitted for ethics approval [1] 286419 0
17/10/2011
Approval date [1] 286419 0
02/11/2011
Ethics approval number [1] 286419 0
HREC/11/QRBW/398

Summary
Brief summary
This study will assess the effect of hyperbaric oxygen therapy on quality of life and saliva in patients with dry mouth (xerostomia) following radiotherapy for head and neck cancer.

Who is it for?
You may be eligible to join this study if you are aged 18-90 years and have been diagnosed with xerostomia of at least 6 months duration following radiotherapy for head and neck cancer.

Trial details
Participants in this trial will be randomly (by chance ) allocated to one of two groups. Participants in one group will undergo 30 daily hyperbaric oxygen treatments of 90 minutes duration each. Participants in the other group will receive 30 placebo (control) treatments initially but will be offered the hyperbaric oxygen treatment after 3 months. Participants will not know which group they are in until the trial is completed.

Participants will be regularly assessed over a 12 month period to determine their quality of life, saliva components and treatment costs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33578 0
Dr Susannah Sherlock
Address 33578 0
RBWH
Herston
qld 4029
Country 33578 0
Australia
Phone 33578 0
+61736460241
Fax 33578 0
+61736460747
Email 33578 0
[email protected]
Contact person for public queries
Name 16825 0
Dr Susannah Sherlock
Address 16825 0
Hyperbaric Medicine Service
RBWH
Butterfield St
Herston
Qld 4029
Country 16825 0
Australia
Phone 16825 0
+61736460241
Fax 16825 0
+61736360747
Email 16825 0
[email protected]
Contact person for scientific queries
Name 7753 0
Dr Susannah Sherlock
Address 7753 0
Hyperbaric Medicine Service
RBWH
Butterfield St
Herston
Qld 4029
Country 7753 0
Australia
Phone 7753 0
+61736460241
Fax 7753 0
+61736360747
Email 7753 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.