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Trial registered on ANZCTR


Registration number
ACTRN12610000962033
Ethics application status
Approved
Date submitted
29/10/2010
Date registered
9/11/2010
Date last updated
9/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of curcumin on paraproteinemia and bone turnover in patients with monoclonal gammopathy of undefined significance (MGUS) and indolent myeloma.
Scientific title
The effect of curcumin on paraproteinemia and bone turnover in patients with monoclonal gammopathy of undefined significance (MGUS) and indolent myeloma.
Secondary ID [1] 252975 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myeloma 258498 0
cancer 258499 0
Condition category
Condition code
Blood 258668 258668 0 0
Haematological diseases
Cancer 258669 258669 0 0
Myeloma
Alternative and Complementary Medicine 258707 258707 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
curcumin - complementary medicine. patients will be administered either 4g curcumin or 4g placebo per day at the start of the study. After 3 months they will be crossed over for a futher 3 months. There is no wash-out period. The curcumin is being administered as stick-packs of granules.
Intervention code [1] 257498 0
Prevention
Intervention code [2] 257538 0
Treatment: Other
Comparator / control treatment
placebo composed of FD&C yellow 6, riboflavin and non-pareil seeds (pharma grade sugar and starch)
Control group
Placebo

Outcomes
Primary outcome [1] 259524 0
decrease in abnormal protein as determined by serum assay.
Timepoint [1] 259524 0
6 months
Secondary outcome [1] 266134 0
decrease in bone turnover as determined by serum assay and urine analysis.
Timepoint [1] 266134 0
6 months

Eligibility
Key inclusion criteria
significant paraproteinemia as defined by a serum M-protein value of equal to or greater than 18g/L.
Minimum age
40 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
other malignancies

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)
Blood tests will determine whether a patient has MGUS or indolent myeloma. Allocation concealment is being done by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257956 0
Hospital
Name [1] 257956 0
St George Hospital
Address [1] 257956 0
Gray street
Kogarah
nsw
2217
Country [1] 257956 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Gray street, Kogarah, NSW, 2217
Country
Australia
Secondary sponsor category [1] 257156 0
None
Name [1] 257156 0
none
Address [1] 257156 0
Country [1] 257156 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259965 0
South Eastern Sydney Illawara Human Research Ethics Committee
Ethics committee address [1] 259965 0
St George Hospital, Gray street, Kogarah, NSW, 2217
Ethics committee country [1] 259965 0
Australia
Date submitted for ethics approval [1] 259965 0
19/11/2008
Approval date [1] 259965 0
02/12/2008
Ethics approval number [1] 259965 0
07/03 Diamond

Summary
Brief summary
Due to the results of previous studies both in vivo and in vitro, we hypothesised that curcumin may decrease paraproteinemia and bone turnover in MGUS and indolent myeloma patients. A pilot study conducted by us showed a reduction in paraprotein levels and the uNTX bone turnover marker in a select group of MGUS patients. This trial is a continuation of the pilot study and we aim to prove that curcumin may act to prevent the progression of MGUS to active myeloma.
Trial website
nil
Trial related presentations / publications
Golombick et al. The potential role of curcumin in patients with MGUS - its effect on paraproteinemia and the urinary N-telopeptide of type 1 collagen bone turnover marker. Clin Cancer Res 2009;15(18) 2009
Public notes

Contacts
Principal investigator
Name 31843 0
Address 31843 0
Country 31843 0
Phone 31843 0
Fax 31843 0
Email 31843 0
Contact person for public queries
Name 15090 0
Terry Golombick
Address 15090 0
level 3
Prichard Wing
St George Hospital
Gray street
Kogarah
NSW
2217
Country 15090 0
Australia
Phone 15090 0
+61 2 91132767
Fax 15090 0
+61 2 91133966
Email 15090 0
terry.golombick@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 6018 0
Terry Golombick
Address 6018 0
level 3
Prichard Wing
St George Hospital
Gray street
Kogarah
NSW
Country 6018 0
Australia
Phone 6018 0
+61 2 91132767
Fax 6018 0
+61 2 91133966
Email 6018 0
terry.golombick@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 2689 0
Clin Cancer Res 2009;15:5917-5922
Attachments [1] 2689 0
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary