None listed
Conditions
Brief summary
Brief description of the study purpose: This pilot study aims to evaluate how effective and well tolerated combined ginger and vitamin B6 supplementation is in preventing or reducing chemotherapy induced nausea and vomiting (CINV) in adults receiving moderate to high emetogenic risk chemotherapy. Who is it for? You may be eligible for this study if you are male or female aged 18 years or older with a cancer diagnosis who are starting moderate to high emetogenic risk chemotherapy and experience nausea and/or vomiting during their first chemotherapy cycle. Study details Participants will first be observed during their initial chemotherapy cycle without ginger or vitamin B6. Those who experience nausea or vomiting will then receive ginger and vitamin B6 supplements alongside standard anti-emetic treatment from cycle 2 onwards, for up to 12 chemotherapy cycles if tolerated. All participants who enter the intervention phase will receive the study supplements; there is no randomisation or element of chance. Outcomes will be measured using patient reported surveys and the MASCC Antiemesis Tool to compare nausea and vomiting before and after the intervention. It is hoped this research will help clarify whether combined use of both ginger and vitamin B6 can be useful, well tolerated supportive options to improve nausea and vomiting control and overall quality of life for patients undergoing chemotherapy.
Interventions
Prospective, single-arm, pre-post intervention pilot study starting from first cycle of chemotherapy and continue for subsequent cycles, if tolerated.
1. Pre-Intervention Phase (Cycle 1 – without ginger/vitamin B6):
Only patients who experience any episode(s) of nausea and/or vomiting during cycle 1 —regardless of whether breakthrough anti-emetic medications are used—will proceed to the intervention phase.
2. Intervention Phase (Cycle 2 onwards – with ginger/vitamin B6):
Eligible patients will
Prospective, single-arm, pre-post intervention pilot study starting from first cycle of chemotherapy and continue for subsequent cycles, if tolerated. 1. Pre-Intervention Phase (Cycle 1 – without ginger/vitamin B6): Only patients who experience any episode(s) of nausea and/or vomiting during cycle 1 —regardless of whether breakthrough anti-emetic medications are used—will proceed to the intervention phase. 2. Intervention Phase (Cycle 2 onwards – with ginger/vitamin B6): Eligible patients will receive the ginger and vitamin B6 supplementation in addition to standard anti-emetic care. . [From Cycle 2 onwards to maximum of 12 treatment cycles or whichever comes first *] 3. Post-Intervention Assessment: Outcomes will be assessed through patient surveys and the MASCC (Multinational association of supportive care in cancer) Antiemesis Tool (MAT) to compare pre- and post-intervention results. Medications used for this trial are as follows: The intervention consists of a single compounded capsule (administered twice daily - morning and night) containing: Dry Ginger powder: 125mg [Total maximum daily dose = 250mg] Pyridoxal-5'-Phosphate (P-5-P), equivalent to Vitamin B6: 12.5mg Pyridoxine hydrochloride [Total maximum daily dose = 25mg] Doxylamine 6.25mg (6.25mg (optional at night-time dose): To be included in the compounded capsule only as determined by the treating doctor • Continuing for 5 days after chemotherapy (Days 2-6) of each cycle from Cycle 2 onwards as outlined in study procedure phase. • If a dose is missed at the usual time, skip the dose and take the dose when it is next due- Do NOT double dose. **Labelling: If Doxylamine is included in the capsule, it must be clearly labelled with dosing instructions and timing (e.g., "Take at night" or "Take with caution - may cause drowsiness") Scenario A: Patient completes 12 chemotherapy cycles: Patient receives ginger + vitamin B6 from Cycle 2 through Cycle 12 (maximum 11 intervention cycles) Scenario B*: Patient's chemotherapy ends before 12 cycles- If patient's treatment plan includes only 6 cycles, intervention continues through Cycle 6 only (maximum 5 intervention cycles) Scenario C: Patient withdraws or intervention stopped early or until discontinuation If adverse effects occur or no improvement is seen, intervention stops before 12 cycles. Adherence monitoring Strategies: 1. Pill counts 2. Adherence Checklist 3. Oncology Treatment Diary Card 4. Patient Interview/ Survey 5. MASCC Anti-emesis Tool (MAT) 6. Clinical observation by treating doctor(s)/ nurse(s)
Sponsors
West Moreton Hospital Foundation
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 No maximum
Healthy volunteers
No
Inclusion criteria
• Inclusion criteria: 1. Adults (> = 18 years) diagnosed with cancer commencing moderate- to high- emetogenic-risk chemotherapy, who required breakthrough anti-emetic medications and/or any episode(s) of nausea/vomiting not requiring breakthrough anti-emetic medications. 2. Eastern Co-operative Oncology Group (ECOG) Performance status 0-2 3. Able to provide informed consent.
Exclusion criteria
• Exclusion criteria: 1. Concurrent herbal remedies to prevent nausea/ vomiting through pre-medication history taking. 2. Pregnancy or lactation 3. Known allergy / intolerance to either ginger or vitamin B6 or both. 4. Pre-existing / Anticipatory nausea or GI disorders. 5. Hepatic or renal dysfunction (relevant to Vitamin B6 metabolism)
Outcome results
None listed