Chemotherapy induced nausea and vomiting
Conditions
Interventions
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 (
Sponsors
Fundació Institut Català de Farmacologia
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 management needs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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 ;Primary end point(s): Primary endpoint is the average of patients in each study arm showing a partial or complete response to treatment. | — |
Countries
Spain
Outcome results
None listed