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.

INTERVENTION: Trade Name: Sativex Product Name: delta9 tetrahidrocannabinol (THC) y cannabidiol (CBD) Product Code: THC CBD Pharmaceutical Form: Sublingual spray INN or Proposed INN: Delta‐9‐Tetrahidrocannabinol (THC) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5/100‐ Pharmaceutical form of the placebo: Sublingual spray Route of administration of the placebo: Sublingual use Trade Name: Sativex Product Name: delta9 tetrahidrocannabinol (THC) y cannabidiol (CBD) Product Code: THC CBD Pharmaceutical Form: Sublingual spray INN or Proposed INN: Cannabiniol (CBD) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5/100‐ CONDITION: Chemotherapy induced nausea and vomiting PRIMARY OUTCOME: Main Objective: To asses preliminary efficacy of an individualized treatment line of Sativex administered by sublingual route added to standard treatment for prevention and treatment of nausea and late vomiting (during the following 120 hours after chemotherapy administration) in patients not responding to standard antihemetic treatment after first cycle of moderately emetogenic chemotherapy Primary end point(s): Primary endpoint is the average of patients in each study arm showing a partial or complete response to treatment.; ; Secondary Objective: To asses preliminary efficacy of Sativex preventing nausea and vomiting during 1st 24hours following chemotherapy in non responders to Standard treatment.; To asses preliminary efficacy of Sativex preventing late vominitng and nausea and also improvement in length and intensity before and after treatment; To measure Sativex impact on pain, asthenia, sleep quality, emotional condition, subjective effects and daily activities.; Mean daily dose and pharmacokinetics.; Changes in analgesic treatment with opioids.; To asses patient and investigator satisfaction rate; 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