Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy

NCT01887314 | Completed DMC

• 1 other identifier: HF01-12-69
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of Ginger in protecting patients from delayed nausea (incidence of no delayed nausea and non-significant delayed nausea)

  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.

  Two High Emetogenic chemotherapy cylces (41 or 55 days)

Secondary Outcomes (3)

• Protection from delayed vomiting (number of emetic episodes in delayed phase)

  Two High Emetogenic chemotherapy cylces (41 or 55 days)

• Use of antiemetic rescue medication.

  Two High Emetogenic chemotherapy cylces (41 or 55 days)

• Overall fatigue assessment (BFI questionnaire)

  Two High Emetogenic chemotherapy cylces (41 or 55 days)

Other Outcomes (2)

• Biochemical markers

  Two High Emetogenic chemotherapy cylces (41 or 55 days)

• To evaluate the safety profile of the product containing Ginger extract.

  Two High Emetogenic chemotherapy cylces (41 or 55 days)

Study Arms (2)

Standardized Ginger extract soft gel capsules

EXPERIMENTAL

Patients receive 2 soft gel capsules of Ginger extract, twice a day

Dietary Supplement: Standardized Ginger extract

Placebo soft gel capsules

PLACEBO COMPARATOR

Patients receive 2 soft gel capsules of Placebo, twice a day

Dietary Supplement: Standardized Ginger extract

Interventions

Standardized Ginger extract DIETARY_SUPPLEMENT

Also known as: Ginpax

Placebo soft gel capsules; Standardized Ginger extract soft gel capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinn Healthcare SA: lead

Study Sites (6)

Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

IEO -Istituto Europeo di Oncologia-

Milan, 20141, Italy

Location

Ospedale S. Gerardo

Monza, 20052, Italy

Location

Policlinico Umberto I

Rome, 00186, Italy

Location

Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori "Regina Elena"

Rome, Italy

Location

Ospedale S. Maria

Terni, 05100, Italy

Location

MeSH Terms

Conditions

Neoplasms; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Bossi, M.D.

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 27, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)