Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000330741
Ethics application status
Approved
Date submitted
25/02/2013
Date registered
25/03/2013
Date last updated
9/05/2019
Date data sharing statement initially provided
9/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of ultraviolet light photochemotherapy Polarised Ultra Violet A [PUVA] in the oral cavity in conjunction with a oral photo-sensitiser [5-methoxypsolaren or 8-methoxypsoralen] for oral graft-versus- host disease [GVHD] in allogeneic bone marrow transplant patients [ABMT].
Scientific title
The use of ultraviolet light photochemotherapy Polarised Ultra Violet A [PUVA] in the oral cavity in conjunction with a oral photo-sensitiser [5-methoxypsolaren or 8-methoxypsoralen] for oral graft-versus- host disease [GVHD] in allogeneic bone marrow transplant patients [ABMT].
Secondary ID [1] 281998 0
nil
Universal Trial Number (UTN)
Trial acronym
PUVA study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Oral Graft versus Host Disease 288437 0
Condition category
Condition code
Blood 288785 288785 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient will recieve a controlled exposure of UVA using a Spectraline wand (A pencil lamp source of UVA light placed in the oral cavity) with the oral photosensitiser 8-Methoxypsoralen (MOP) at a dose of 0.6mg/kg or 5 MOP at a dose of 1.2mg/kg given two hours before each treatment.
Exposure to the UVA light starts at 15 sec and increments by 15 secs once a week to a total of 60 secs. All patients will be offered a total of 40 treatments with an average of four treatments per week. Patients complete the treatment using the same oral photosensitiser they start with, and supply/ availability of the drug determines which one the patient uses.
Intervention code [1] 286571 0
Treatment: Devices
Intervention code [2] 286599 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288923 0
GVHD severity as scored by the 15 point Schubert Scale (physical examination of oral cavity).
Timepoint [1] 288923 0
At baseline (screening visit) and then at the end of treatment (treatment 40 or earlier).
Primary outcome [2] 288924 0
Severity of mucosits as determined by the World Health Organisation oral mucositis scale (clinical assessment and scoring of nutrition, discomfort, saliva production and physical examination of oral cavity).
Timepoint [2] 288924 0
At baseline (screening visit) and then at the end of treatment (treatment 40 or earlier).
Secondary outcome [1] 301369 0
Mortality due to oral GVHD defined as death directly to complications of oral GVHD or its treatments.
Timepoint [1] 301369 0
At each of the 40 treatment sessions and then at ongoing annual followup at the Long Term Transplant Survivor Clinic.
Secondary outcome [2] 301370 0
Overall Survival
Timepoint [2] 301370 0
At each of the 40 treatment sessions and then at ongoing annual followup at the Long Term Transplant Survivor Clinic.
Secondary outcome [3] 301829 0
Nutrition, assessed with body weight changes and the need to use parenteral nutrition.
Timepoint [3] 301829 0
At each of the 40 treatment sessions and then at ongoing annual followup at the Long Term Transplant Survivor Clinic.
Secondary outcome [4] 301830 0
Hospitalisation as measured by documented numbers of admissions and length of hospital stay.
Timepoint [4] 301830 0
At each of the 40 treatment sessions and then at ongoing annual followup at the Long Term Transplant Survivor Clinic.
Secondary outcome [5] 301831 0
Use of immunosuppression (names and doses of immunosuppression used)
Timepoint [5] 301831 0
At each study treatment.
Secondary outcome [6] 301832 0
Numbers, type and distribution of skin cancers assessed clinically by a qualified physician or dermatologist.
Timepoint [6] 301832 0
At baseline, each study treatment and after final treatment.
Secondary outcome [7] 301833 0
Sites and severity of Infections assessed clinically and from records.
Timepoint [7] 301833 0
At each of the 40 treatment sessions and then at ongoing annual followup at the Long Term Transplant Survivor Clinic.

Eligibility
Key inclusion criteria
Undergone Allogeneic Stem cell transplant with clinical diagnosis of oral GVHD and any degree or oral symptoms leading to pain, discomfort and interfere with oral intake.
Histological confirmation not required.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sensivity to sunscreens and photosensitisers.
Known photodermatoses.
Foreseeable intense exposure to solar or UV exposure except study related.
unable to take tablets

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
open label
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2010
Actual
2/02/2010
Date of last participant enrolment
Anticipated
1/02/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 638 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 6371 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 286779 0
Hospital
Name [1] 286779 0
St Vincent's Hospital, Sydney
Country [1] 286779 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 285562 0
None
Name [1] 285562 0
Address [1] 285562 0
Country [1] 285562 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288844 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 288844 0
St Vincent's Hospital, Sydney
390 Victora St
Darlinghurst NSw 2010
Ethics committee country [1] 288844 0
Australia
Date submitted for ethics approval [1] 288844 0
21/09/2009
Approval date [1] 288844 0
21/12/2009
Ethics approval number [1] 288844 0
HREC/09/SVH/132

Summary
Brief summary
Patient will recieve a controlled exposure of UVA using a Spectraline wand with a an oral photosensitiser such as 8 MOP or 5 MOP. Exposure to the UVA starts at 15 sec and increments by 15 secs once a week to a maximium exposure of 60 secs. All patients will be offered a total of 40 treatments of the combined therpay. Patients will be evaluated by their specialist at treatments 1, 10, 20 and at treatment 40 or termination/withdrawal. Early conclusion or treatment or temporary interuptions are permitted if remission is attained.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37998 0
Dr John Moore
Address 37998 0
Kinghorn Cancer Centre
St Vincent's Hospital, Sydney
370 Victoria St
Darlinghurst NSw 2010
Country 37998 0
Australia
Phone 37998 0
61 2 9355 5656
Fax 37998 0
61 2 9355 5735
Email 37998 0
SVHS.CancerResearch@svh.org.au
Contact person for public queries
Name 37999 0
Mr Robert Kent
Address 37999 0
Kinghorn Cancer Centre
St Vincent's Hospital, Sydney
370 Victoria St
Darlinghurst NSw 2010
Country 37999 0
Australia
Phone 37999 0
+61 2 9355 5611
Fax 37999 0
61 2 9355 5735
Email 37999 0
SVHS.CancerResearch@svh.org.au
Contact person for scientific queries
Name 38000 0
Dr John Moore
Address 38000 0
Kinghorn Cancer Centre
St Vincent's Hospital, Sydney
370 Victoria St
Darlinghurst NSw 2010
Country 38000 0
Australia
Phone 38000 0
61 2 9355 5656
Fax 38000 0
61 2 9355 5735
Email 38000 0
SVHS.CancerResearch@svh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not apart of ethics approval


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.