Aromatase iNhibitor-induced chronic resistaNt pAin in Breast cancer patIents MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Cannabis FM2 Olio
Product Code: [Cannabis FM2]
Pharmaceutical Form: Oral liquid
CAS Number: 23978-85-0
Current Sponsor code: 1
Other descriptive name: delta-9-tetrahydrocannabinolic acid
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¿ Women ¿Age 18 years or older ¿Patients on aromatase inhibitor therapy for breast cancer ¿ Menopausal patients defined as 12 continuous months of amenorrhea related to elevated FSH levels (>19.3 IU/mL) ¿ Menopausal patients as a result of medications such as: in chemotherapy or antihormonal therapy, suffering from estrogen- and progesterone-sensitive breast cancer; in pelvic radiation therapy, for carcinomas of the cervix, usually from HPV, with heavy genital and sexual damage, because of the vascular damage and fibrosis they generate in the genital area (Graziottin and Basson 2004; Graziottin and Lukasiewicz 2015); in total-body radiation therapy, which is required before marrow transplantation (Graziottin and Lukasiewicz 2015). Postmenopausal FSH values IU/mL: 19.3-100.6. ¿ Patients with high FSH values (>19.3 IU/mL) and undergoing hysterectomy, hysteroannessiectomy, bilateral adnexiectomy, for whom the criterion of absence of menstrual cycles is not usable ¿ Patients with chronic pain (persistent for more than 3 months; IASP Classification - Treede, 2019) ¿ Patients with pain resistant to conventional therapies (patients treated with usual care who do not achieve at least 50% pain reduction; Moore, 2013) ¿ Ability to give informed consent ¿ Written adherence to the protocol with willingness to participate in the study (signing of 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 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: ¿ Patients with respiratory failure (arterial partial pressure of oxygen =2), arrhythmia, uncontrolled hypertension (>135/85) ¿ Patients with myocardial infarction in the 12 months before study entry ¿ Patients with severe hepatic impairment (aspartate aminotransferase three times greater than the upper limit) ¿Patients with severe renal impairment (eGFR <30) ¿Patients with chronic hepatitis C ¿ Personal history of psychiatric disorders (psychosis, bipolar disorder, major depression) and/or family history of schizophrenia ¿ Previous and/or current history of drug or psychotropic substance or alcohol abuse ¿ Patients treated with sedative hypnotic, antidepressant, or psychoactive medications 11 ¿ Non-compliance with study procedure for medical judgment ¿ Cannabis abuse and/or Use of cannabis for other illnesses within the past 3 months. A negative analytical control test on biological matrix (urine test) for the absence of cannabinoids must be available for all patients before the start of the study (time 0)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the project is to assess the efficacy and safety of Cannabis when added to the usual care of chronic pain induced by the aromatase inhibitors in breast cancer patients.;Secondary Objective: Secondary objectives are: - to evaluate the impact of pain on the quality of life of patient; - to examine the pharmacokinetics of Cannabis (i.e. THC, CBD and myrcene blood concentration); - to explore Cannabis preparations in terms of active principles composition; - to evaluate adherence to aromatase inhibitor therapy;Primary end point(s): efficacy and safity Cannabis galenic Preparations;Timepoint(s) of evaluation of this end point: Duration of study per patient 12 months Duration of enrollment 18 months Duration of the study in full 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): quality of life of patients;Timepoint(s) of evaluation of this end point: Duration of study per patient 12 months Duration of the study in full 36 months | — |
Countries
Italy
Contacts
Public ContactCerfit
Aou-Careggi
Outcome results
None listed