Efficacy Study of Ginger (Zingiber Officinale) Extract to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy
The purpose of the study is verify the capability of a standardized Ginger (Zingiber officinale) extract to manage nausea in cancer patients receiving highly emetogenic treatments and standard anti-emetogenic therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||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.|
- To evaluate the efficacy of Ginger in protecting patients from delayed nausea (incidence of no delayed nausea and non-significant delayed nausea) [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ] [ Designated as safety issue: No ]
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.
- Protection from delayed vomiting (number of emetic episodes in delayed phase) [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ] [ Designated as safety issue: No ]
- Use of antiemetic rescue medication. [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ] [ Designated as safety issue: No ]
- Overall fatigue assessment (BFI questionnaire) [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ] [ Designated as safety issue: No ]
- Biochemical markers [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ] [ Designated as safety issue: No ]
On a restricted number of patients enrolled at the coordinating center, additional blood samples will be collected for IL-6, TNF-alpha, IGF-1 evaluation.
The purpose of this additional research is to evaluate if the consumption of ginger can affect serum concentration of such factors.
- To evaluate the safety profile of the product containing Ginger extract. [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ] [ Designated as safety issue: Yes ]Number and typology of adverse events
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Standardized Ginger extract soft gel capsules
Patients receive 2 soft gel capsules of Ginger extract, twice a day
Dietary Supplement: Standardized Ginger extract
Placebo Comparator: Placebo soft gel capsules
Patients receive 2 soft gel capsules of Placebo, twice a day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01887314
|Contact: Paolo Bossi, M.D.||firstname.lastname@example.org|
|Istituto Nazionale dei Tumori||Recruiting|
|Milan, Italy, 20133|
|Contact: Paolo Bossi, MD email@example.com|
|Principal Investigator: Paolo Bossi, M.D.|
|IEO -Istituto Europeo di Oncologia-||Recruiting|
|Milan, Italy, 20141|
|Contact: Franco Nolè, MD|
|Principal Investigator: Franco Nolè, MD|
|Ospedale S. Gerardo||Recruiting|
|Monza, Italy, 20052|
|Contact: Diego Cortinovis, MD|
|Principal Investigator: Diego Cortinovis, MD|
|Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori "Regina Elena"||Recruiting|
|Contact: Alessandra Fabi, MD firstname.lastname@example.org|
|Principal Investigator: Alessandra Fabi, MD|
|Policlinico Umberto I||Recruiting|
|Rome, Italy, 00186|
|Contact: Patrizia Seminara, MD|
|Principal Investigator: Patrizia Seminara, MD|
|Ospedale S. Maria||Recruiting|
|Terni, Italy, 05100|
|Contact: Fausto Roila, MD|
|Principal Investigator: Fausto Roila, MD|
|Principal Investigator:||Paolo Bossi, M.D.||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|