Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001349639
Ethics application status
Approved
Date submitted
6/11/2023
Date registered
21/12/2023
Date last updated
1/06/2024
Date data sharing statement initially provided
21/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing ginger (6-Shogaol) in improving blood markers (cytopenias) of patients with lower risk Myelodysplastic Syndromes – a pilot clinical trial
Scientific title
Assessing the efficacy and safety of 6-Shogaol in improving cytopenias of patients with lower risk Myelodysplastic Syndromes – a pilot clinical trial
Secondary ID [1] 310902 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic syndrome 331957 0
Condition category
Condition code
Blood 328685 328685 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20mg ginger extract standardised to 20% 6-Shogaol in a soft-gel capsule

Dose: 1 capsule (20mg) taken orally after food once a day.
Duration of administration is 28 weeks (6 months)
Mode: Taken orally after food once a day.
Monitoring: Diary and tablet counting at each visit will assist in monitoring adherence
Intervention code [1] 327330 0
Prevention
Comparator / control treatment
No comparator or control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336501 0
Efficacy of 6-Shogaol on full blood count over 24 weeks
Timepoint [1] 336501 0
Baseline compared to 24 weeks post-baseline visit
Primary outcome [2] 336502 0
Efficacy of 6-Shogaol on reticulocyte counts over 24 weeks.
Timepoint [2] 336502 0
Baseline compared to 24 weeks post-baseline visit.
Primary outcome [3] 336503 0
Efficacy of 6-Shogaol on ferritin levels over 24 weeks
Timepoint [3] 336503 0
Baseline compared to 24 weeks post-baseline visit.
Secondary outcome [1] 428588 0
Time to disease progression
Timepoint [1] 428588 0
Baseline compared to week 24 post base-line visit.
Secondary outcome [2] 428589 0
Overall survival
Timepoint [2] 428589 0
Baseline compared to week 24 post baseline-line visit.
Secondary outcome [3] 428590 0
Cytogenic response
Timepoint [3] 428590 0
Baseline compared to week 8, week 16 and week 24 post-baseline visit.
Secondary outcome [4] 428591 0
Safety of 6-Shogaol
Timepoint [4] 428591 0
Baseline compared to week 24 post-baseline visit
Secondary outcome [5] 428592 0
Safety of 6-Shogaol
Timepoint [5] 428592 0
Baseline compared to week 24 post-baseline visit.
Secondary outcome [6] 428593 0
Assessment of hepatoprotective effects of 6-Shogaol
Timepoint [6] 428593 0
Baseline compared to week 8, 16 and week 24 post-baseline visit.
Secondary outcome [7] 428595 0
Assessment of participant compliance with treatment
Timepoint [7] 428595 0
Baseline compared to week 24 post-baseline visit.
Secondary outcome [8] 428596 0
Impact of 6-Shogaol on quality of life
Timepoint [8] 428596 0
Baseline compared to week 24 post-baseline visit.
Secondary outcome [9] 428598 0
Impact of 6-Shogaol on Quality of life
Timepoint [9] 428598 0
Baseline compared to week 24 post-baseline visit.
Secondary outcome [10] 428599 0
Efficacy of 6-Shogaol on thyroid function
Timepoint [10] 428599 0
Baseline compared to week 24 post-baseline visit.
Secondary outcome [11] 429995 0
Progression free survival
Timepoint [11] 429995 0
Baseline compared to week 28 post-baseline visit

Eligibility
Key inclusion criteria
Confirmed diagnosis (using standard French-American-British (FAB) criteria) of MDS
MDS patients belonging to low, Int-1 risk disease by IPSS criteria life expectancy greater than 3 months
Newly diagnosed as well as previously treated patients with de novo or secondary MDS will be eligible.
Performance Status 0-2 using Eastern Cooperative Oncology Group (ECOG) scale
Serum ferritin on screening pathology greater or equal to 100 ug/L
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
MDS treatments
Previous treatment with chemotherapy, chelation therapy hematopoietic growth factors, erythropoietin, or cytokines within the 4 weeks prior to starting the IMP
Planned treatment with chemotherapy, chelation therapy, hematopoietic growth factors, erythropoietin, or cytokines during the course of the trial
Concomitant use or planned concomitant use of recombinant erythropoietin or platelet stimulating factors during the trial
Concomitant use or planned concomitant use of any other experimental agent aimed at treating MDS during the trial

Medical History
An active, clinically significant infection that is not effectively controlled with antimicrobial or antiviral therapy
Current, clinically significant active cardiac disease, including congestive heart failure
Current, clinically significant renal disease
Current, clinically significant bleeding disorder
Known allergy to ginger or ginger-based products

Mental Health
Severe mental illness

Medications
Concomitant use of any medication with a known, clinically significant interaction with the IMP (e.g. anti-diabetic drugs, calcium channel blockers, cyclosporine, metronidazole)
Regular, concomitant use of prescription anticoagulant medications such as warfarin, Eliquis, Pradaxa, Lixiana and Xeralto. (Sporadic PRN use of aspirin is permissible. Regular low dose aspirin ( less then or equal to 100mg per day) is permissible. Supplements with anticoagulant properties are permissible)

Other
Pregnant or breast-feeding

Pathology abnormalities
Clinically significant abnormality on any pre-existing ECG
Liver function tests greater than 2 times ULN AND of clinical significance
BUN and or Creatinine greater than 2 times ULN AND of clinical significance

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
All data will be analysed via SPSS 27.0 and or R. Analyses will be conducted on an intention-to-treat basis with per-protocol subgroup analysis. Missing data will be imputed by multiple imputation techniques.

Descriptive statistics will summarise data and be presented as either means and standard deviations or medians with interquartile range for continuous data, or absolute and relative frequencies for categorical data. Outcome measures of SF level, serum hepcidin level, EQ-5D and EORTC QoL C30 will be analysed using ANOVA with repeated measures.
Comparisons via paired t-tests will be performed where significance is observed. The significance level is set at p less than 0.05. The Bonferroni adjustment or the false discovery rates (FDR) will be applied to adjust the p-values in case of multiple comparisons to control the final type-I errors. Improvements in cytopenia’s will be reported as response rates.

Interim analysis
No interim analysis has been planned.

IMP compliance data
The IMP compliance data will be collated over the trial period and showcased as both absolute and relative frequencies. Compliance data will be used as a covariate for the analysis of the primary and secondary outcomes in ANCOVA and linear regression analyses.

Adverse Event data
We will present the adverse event occurrences using absolute and relative frequencies, allowing us to quantify the prevalence of events within the dataset. This presentation will be carried out separately for both system organ classes and severity levels.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/01/2024
Actual
23/04/2024
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
30
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25804 0
Illawarra Private Cancer Care & Research Centre - Wollongong
Recruitment postcode(s) [1] 41630 0
2500 - Wollongong
Recruitment postcode(s) [2] 41631 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 315158 0
Commercial sector/Industry
Name [1] 315158 0
American Medical Holdings
Country [1] 315158 0
United States of America
Primary sponsor type
University
Name
Southern Cross University
Address
1 Military Road, Lismore, NSW 2480
Country
Australia
Secondary sponsor category [1] 317178 0
None
Name [1] 317178 0
Address [1] 317178 0
Country [1] 317178 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314095 0
Southern Cross University HREC
Ethics committee address [1] 314095 0
Ethics committee country [1] 314095 0
Australia
Date submitted for ethics approval [1] 314095 0
30/11/2023
Approval date [1] 314095 0
27/02/2024
Ethics approval number [1] 314095 0
2024/019

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130390 0
Prof Manoharan Arumugam
Address 130390 0
Southern Sydney Heamatology, Suite7/1-5 Derby St, Kogarah NSW 2217
Country 130390 0
Australia
Phone 130390 0
+61 295531272
Fax 130390 0
Email 130390 0
[email protected]
Contact person for public queries
Name 130391 0
Janet Schloss
Address 130391 0
Southern Cross University, NCNM, 1 Military Road, Lismore NSW 2480
Country 130391 0
Australia
Phone 130391 0
+61 436101306
Fax 130391 0
Email 130391 0
[email protected]
Contact person for scientific queries
Name 130392 0
Janet Schloss
Address 130392 0
Southern Cross University, NCNM 1 Military Road, Lismore NSW 2480
Country 130392 0
Australia
Phone 130392 0
+61 436101306
Fax 130392 0
Email 130392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification that was included in published results only
When will data be available (start and end dates)?
Following publication up to 5 years
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose, only to achieve the aims in the approved proposal, for IPD meta-analyses, etc.
How or where can data be obtained?
Access subject to approvals by Principal Coordinating Investigator via email [email protected]


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.