Multicenter, Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Activity of a Ginger (Zingiber Officinale) Food Supplement in the Management of Nausea in Patients Receiving Highly Emetogenic Treatments and Standard Anti-emetogenic Therapy.
18 Years
N/A
Both
Cancer, Nausea, Vomiting
Trial Information
Multicenter, Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Activity of a Ginger (Zingiber Officinale) Food Supplement in the Management of Nausea in Patients Receiving Highly Emetogenic Treatments and Standard Anti-emetogenic Therapy.
This study is a randomized, double-blind, placebo controlled, multicenter study with two
parallel groups of patients.
The study will be conducted in 5 Italian clinical sites and will involve 250 patients
receiving at least 2 cycles of highly emetogenic treatments.
Patients will be randomly assigned to Ginger treatment or to its Placebo.
All patients will receive, at each chemotherapy cycle, the standard 5-HT3 receptor
antagonist antiemetics plus dexamethasone and NK1 receptor antagonist. This will guarantee
to all patients an antiemetic prophylaxis for acute and delayed nausea. No additional
treatment is usually foreseen for nausea and this justifies the use of placebo in the
control group.
Patients will start the study treatment on the day after chemotherapy cycle and will
continue until the day of the following cycle; they will suspend the study treatment on the
chemotherapy day and will start again on the next day. The choice not to treat the patients
with the study product on the chemotherapy day is intended to avoid any possible
interference with antiemetic therapy of the first day and chemotherapy, and to analyze the
impact of Ginger in delayed phase without confounding factors in acute phase.
Main efficacy assessment of this study is:
- To evaluate the protection from delayed nausea (incidence of no delayed nausea and
non-significant delayed nausea);
Other efficacy assessments regarding nausea that will be evaluated are:
- To evaluate the severity of delayed nausea;
- To evaluate the overall duration of nausea;
- To evaluate inter cycle nausea;
- To evaluate nausea anticipatory symptoms before the 2nd cycle.
Secondary efficacy assessments of this study are:
- To evaluate protection from delayed vomiting (number of emetic episodes in delayed
phase);
- To evaluate the impact of nausea/vomiting on daily life activities (FLIE30
questionnaire);
- To evaluate the use of antiemetic rescue medication;
- To evaluate the compliance to the treatment;
- To assess overall fatigue (BFI31 questionnaire).
Safety assessments of this study are:
- Number and typology of adverse events.
Inclusion Criteria:
- Male and Females aged > 18 years.
- Naïve to chemotherapy.
- Patients planned to receive at least 2 cycles of highly emetogenic treatments with
cisplatin in single dose > 50 mg/m2 every 21 or 28 days.
- Willing and able to understand and sign informed consent and complete the patient
diary.
Exclusion Criteria:
- Presence of brain symptomatic metastases (in case of small, asymptomatic metastases
and in absence of steroids treatment, the patient is eligible).
- Scheduled to receive or having received in the past 4 weeks radiation treatment to
brain, abdomen or pelvis.
- Emesis or significant nausea within 24 hours before first chemotherapy cycle.
- Known hypersensitivity reaction to Ginger or any components of the product.
- Patients with coagulopathies causing potential increase risk of bleeding.
- Patients on therapy with oral anticoagulants.
- Planned surgery procedures in the period of the study or within 2 weeks after the
study conclusion.
- History of seizures.
- Active use of cannabinoids.
- Known current or past drug or alcohol abuse.
- Use of other investigational drugs within 30 days before study entry or during the
study.
- Clinically significant findings on physical exam or presence of known clinically
significant disease that would interfere with study evaluation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
To evaluate the efficacy of Ginger in protecting patients from delayed nausea (incidence of no delayed nausea and non-significant delayed nausea)
Outcome Description:
The level of nausea will be assessed through a Visual Analogue Scale (VAS 0-100 mm) included in the patients' daily diary. The patients will be asked to report the maximum level of nausea experienced during each day. During each chemotherapy cycle, the nausea occurring between day 2 and day 5 will be defined as "delayed nausea", the nausea occurring between day 6 and day 19/26 will be considered as "inter-cycle nausea". The day before the next chemotherapy cycle (day 20/27), "anticipatory nausea" symptoms will be collected.
Outcome Time Frame:
Two High Emetogenic chemotherapy cylces (41 or 55 days)
Safety Issue:
No
Principal Investigator
Paolo Bossi, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Authority:
Italy: Ministry of Health
Study ID:
HF01-12-69
NCT ID:
NCT01887314
Start Date:
June 2013
Completion Date:
October 2014
Related Keywords:
- Cancer
- Nausea
- Vomiting
- Cancer
- Cisplatin
- Nausea
- Ginger
- Zingiber officinale
- 5HT3
- Dexamethasone
- Neurokinin-1 (NK-1)
- Interleukin-6 (IL-6)
- Tumor necrosis factor-alpha (TNF-alpha)
- Insulin like growth factor-1 (IGF-1)
- Placebo
- FLIE
- BFI
- Nausea
- Vomiting
Name | Location |
|---|
