Clinical trial NCT01887314: Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Nausea
Vomiting
Keywords: 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
Lead sponsor: Helsinn Healthcare SA
Sponsor class: INDUSTRY
First posted: 2013-06-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the efficacy of Ginger in protecting patients from delayed nausea (incidence of no delayed nausea and non-significant delayed nausea)
timeFrame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Secondary outcomes:
measure: Protection from delayed vomiting (number of emetic episodes in delayed phase)
timeFrame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
measure: Use of antiemetic rescue medication.
timeFrame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
measure: Overall fatigue assessment (BFI questionnaire)
timeFrame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Other outcomes:
measure: Biochemical markers
timeFrame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
measure: To evaluate the safety profile of the product containing Ginger extract.
timeFrame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Locations:
city: Milan
country: Italy
facility: Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: IEO -Istituto Europeo di Oncologia-
city: Monza
country: Italy
facility: Ospedale S. Gerardo
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Rome
country: Italy
facility: Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori "Regina Elena"
city: Terni
country: Italy
facility: Ospedale S. Maria
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Paolo Bossi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: