None listed
Conditions
Brief summary
Shogaols are biologically active constituents of ginger which have a chemical structure similar to gingerols. The most common constituent is 6-Shogaol which has been shown to be a promising anti-cancer and anti-inflammatory agent that also possesses strong hepatoprotective effects (Zhang et al., 2019). In a small investigative study among six early-stage, transfusion-independent patients with MDS, Golombick et al. (2017) found that 6-Shogaol caused a decrease in the serum ferritin (SF) levels of three patients who had elevated SF at baseline. Upregulation of hepcidin levels was observed in two of these three patients, possibly through an improvement in liver function with 6-Shogaol supplementation. Hence, 6-Shogaol, a natural food derivative, may lower the iron overload by decreasing iron absorption. Such promising findings call for a more extensive study to confirm the potential beneficial effect of 6-Shogaol in low-risk MDS patients with SF levels greater than or equal to 100ug/L due to ineffective erythropoiesis. Furthermore, whether the lowering of SF levels in this group of patients can translate into improvements in cytopenias and QoL also requires investigating.
Interventions
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
Sponsors
Southern Cross University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
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
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
Outcome results
None listed