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Trial registered on ANZCTR


Registration number
ACTRN12619000736145
Ethics application status
Approved
Date submitted
8/05/2019
Date registered
16/05/2019
Date last updated
16/05/2019
Date data sharing statement initially provided
16/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin C supplementation of myeloma patients undergoing stem cell transplantation
Scientific title
Vitamin C supplementation of myeloma patients undergoing stem cell transplantation: a pilot study to evaluate effect on vitamin C status
Secondary ID [1] 298181 0
None
Universal Trial Number (UTN)
U1111-1231-2396
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myeloma 312764 0
Condition category
Condition code
Cancer 311261 311261 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin C tablets: 1g twice daily for 5 weeks
Commencing one week prior to HSCT
Adherence monitored by tablet return and plasma levels


Intervention code [1] 314412 0
Treatment: Other
Comparator / control treatment
Chewable placebo tablets matched for taste and administered as above
Control group
Placebo

Outcomes
Primary outcome [1] 320001 0
To determine the proportion of participants who achieve and maintain adequate levels of vitamin C, defined as a minimum level of 50 µmol/L plasma vitamin C.
Timepoint [1] 320001 0
Weekly assessments over 5 weeks (and after 2 week washout for a subset of patients)
Secondary outcome [1] 370162 0
To assess biomarkers of inflammation (exploratory, e.g. CRP, procalcitonin, cell counts and differentials).
Timepoint [1] 370162 0
weekly assessments over 5 weeks (and after 2 week washout for a subset of patients).
Secondary outcome [2] 370163 0
To assess the composite of incidence and severity of infectious episodes (febrile neutropenia), as assessed by presence of fever (thermometer >38 degrees Celsius) and plasma C-reactive protein levels (>50 mg/L).
Timepoint [2] 370163 0
Weekly assessments carried out over 5 weeks
Secondary outcome [3] 370164 0
To assess the composite of incidence and severity of oral mucositis using the WHO oral toxicity scale
Timepoint [3] 370164 0
weekly assessments over 5 weeks
Secondary outcome [4] 370165 0
To assess health-related quality of life using the EORTC QLQ C30 form
Timepoint [4] 370165 0
weekly assessments over 5 weeks

Eligibility
Key inclusion criteria
1. Myeloma patient scheduled for HSCT
2. Aged 18 years and over
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Not able to provide informed consent
2. Poor renal function (creatinine clearance <10 mls/sec or glomerular filtration rate <15)
3. Haemochromatosis

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21459 0
New Zealand
State/province [1] 21459 0

Funding & Sponsors
Funding source category [1] 302721 0
Charities/Societies/Foundations
Name [1] 302721 0
Richdale Charitable Trust
Address [1] 302721 0
Richdale Charitable Trust
c/o University of Otago,
PO Box 56.
Dunedin 9054
Country [1] 302721 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago,
PO Box 56.
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 302651 0
None
Name [1] 302651 0
Address [1] 302651 0
Country [1] 302651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303326 0
HDEC Central committee
Ethics committee address [1] 303326 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 303326 0
New Zealand
Date submitted for ethics approval [1] 303326 0
Approval date [1] 303326 0
07/05/2019
Ethics approval number [1] 303326 0

Summary
Brief summary
Haematopoietic stem cell transplantation, in conjunction with chemotherapy, is a standard treatment for patients with myeloma. However, stem cell transplantation can have major treatment-related complications, including increased risk of infection and inflammatory conditions, as well as a decrease in quality of life. Vitamin C is known to exhibit antioxidant and anti-inflammatory functions and is required for optimal immune system functioning. Significantly decreased plasma vitamin C concentrations have been observed in myeloma patients undergoing conditioning chemotherapy followed by stem cell transplantation.

The purpose of this study is to investigate the effect of oral vitamin C supplementation of myeloma patients undergoing stem cell transplantation on plasma vitamin C status. The effect of supplementation on the incidence and severity of severe infection and oral mucositis (inflammation of membranes lining the digestive tract), and changes in patient quality of life will also be monitored in comparison with a placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93286 0
A/Prof Anitra Carr
Address 93286 0
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 93286 0
New Zealand
Phone 93286 0
+64 33640649
Fax 93286 0
Email 93286 0
anitra.carr@otago.ac.nz
Contact person for public queries
Name 93287 0
A/Prof Anitra Carr
Address 93287 0
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 93287 0
New Zealand
Phone 93287 0
+64 33640649
Fax 93287 0
Email 93287 0
anitra.carr@otago.ac.nz
Contact person for scientific queries
Name 93288 0
A/Prof Anitra Carr
Address 93288 0
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 93288 0
New Zealand
Phone 93288 0
+64 33640649
Fax 93288 0
Email 93288 0
anitra.carr@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results