Randomized, double blind, parallel groups, placebo controlled pivotal clinical trial to asses preliminary efficacy and security of a sublingual Cannabis Standardized Extract (Sativex) added to reference treatment for prevention and treatment of nausea and late vomiting induced by moderately emetogenic chemotherapy. - SATEME-08

• Conditions: Chemotherapy induced nausea and vomiting

• Registration Number: EUCTR2004-003824-36-ES
• Lead Sponsor: Fundació Institut Català de Farmacologia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•18 years or older
•Solid malignancy diagnosed to be treated with 1st line chemotherapy (2nd cycle) mildly emetogenic. (1 day carboplatin/cisplatin/ciclophosfamide, doxorubicine, idarrubicine, irinotecan, mitoxantrona or epirrubicine) combine or in monotherapy.
•Patients with at least 1 vomit/day and nausea scored > 25 mm EAV despite antiemetiec prophylaxis treatment.
•Patients receiving prophylaxis treatment for late vomits and nausea
•Karnofsky scale = or >70
•Haematological and metabolic condition stable enough to receive the chemotherapy.
Leuco > 3000/mm3
Platls >100.000/mm3
Serum Creatinine <1,5 mg/dl
•Able to complete questionnaires, diary and visual scale.
•Patien having given informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•more than 1 chemotherapy cycle. Biologic or hormonal therapies are permitted.
•Background of hypersensitivity to cannabinoids.
•cannabinoids use within 30d before inclusion
•Systemic corticosteroid treatment within 72h before 1st dose of study medication (only accepted if pre-treatment to chemotherapy)
•Patients receiving abdominal or pelvic radiotherapy within 7 days before study drug 1ss dose or so scheduled for the following 6 days
•Patients with vomits and nauseas due to known reason including (but no limited): GI obstruction, intracranial pressure, hypocalcaemia, active peptic ulcers.
•Patients with active systemic infection or any other uncontrolled conditions (apart from cancer) that according to investigator judgement could affect patient security or study results
•Patients with AST and or ALT>2,5 x UNL without diagnosed hepatic metastasis (or x5 if hepatic affection diagnosed)
•Patients receiving investigational drug within 30days before inclusion or willing to receive it during the study period.
•Drug / Alcohol abuse background (Confirmed Test Insta-Check)
•History of cardiovascular illness.
•Cognitive deterioration affecting patient collaboration.
•Severe psychiatric illness (schizophrenia, severe depression, etc..).
•Pregnant or breast-feeding woman
•Driving needs or dangerous engine managementneeds.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified