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Thai cannabis practice patterns and quality of life study

ABSTRACT: Interventions: Subjects receive the prescribed Thai Cannabis Oil using the regimen at the discretion of the Thai traditional medicine practitioners. The practice patterns are recorded.;Supportive Care;Thai Cannabis Oil Primary outcome(s): Quality of Life Visit 0, 1, 2, 3 (monthly) Edmonton Symptom Assessment Scale (ESAS),Quality of Life Visit 0, 1, 2, 3 (monthly) ED-5D-5L

DISEASE(S): Appetite,Cannabis,Pain,Sleep Initiation And Maintenance Disorders,Migraine Disorders,Cancers (breast, Lung, Liver, Intestine, Pelvic, Prostate, Stomach, Etc.)insomniapainmigrainepoor Appetiteseizurestremorallergy,Medicine, Traditional,Neoplasms

PROVIDER: 2568450 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Participants of this study will be receiving prescribed medicinal cannabis product/s via their treating clinician, as per standard of care. Enrolment into the study requires their clinician to consent participants and provide relevant medical history information, prescription information and updates and regular adverse event reporting throughout the study duration (12 months observation per participant). Participants will be asked to complete a total of 14 questionnaires at set time points throughout the study. The study progress questionnaire including additional validated measures of health-related quality of life, medication adherence and patient reported change will be completed at enrolment, and months 1, 3, 6, 9 and 12 post-enrolment or until the participant ceases medicinal cannabis treatment (if prior to 12 months post-enrolment). A short-form questionnaire focused on side effect reporting, current dose and changes to other concomitant medications will be completed at months 2, 4, 5, 7, 8, 10 and 11 post-enrolment or until the participant ceases medicinal cannabis treatment (if prior to 12 months post-enrolment). It is anticipated that each questionnaire will take between 5-30 minutes to complete, requiring a total of 30 minutes maximum participation each month for the 12 months of the study. Clinicians will be asked to complete the baseline enrolment form (10 minutes to complete) for each patient at study enrolment as well as adverse event monitoring questionnaires, each taking 5-10 minutes to complete every 3 months for the period that they have patients enrolled in the study. Primary outcome(s): The type of medicinal cannabis product/s prescribed (including the formulation, prescribed dosage and underlying medical condition) as collected by study-specific questionnaires. [Collected at baseline, and then monthly for a 12 month period post-enrolment. ];Number of adverse and serious adverse events experienced that are related to medicinal cannabis treatment, including but not limited to, dry mouth, somnolence and gastrointestinal upset, as measured by study-specific questionnaires. These will be captured by clinicians at clinical examinations and also reported by patients on a monthly basis using the safety reporting questionnaire. The safety reporting questionnaires being used are study specific. The clinician AE reporting questionnaire is based on the TGA recommended guidelines for AE reporting which conform to WHO grading and causality definitions. [Patient reported data collected at baseline, and then monthly for a 12 month period post-enrolment. Clinician reported data collected at 3, 6, 9 and 12 months post-enrolment. ];Change to patient-reported concomitant medications (including opioid use) over the observational period using study-specific questionnaires. [Completed at baseline, and then monthly for 12 months post-enrolment. ] Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective

Project description:Fish oil supplementation has been shown to alter gene expression of mononuclear cells both in vitro and in vivo. However, little is known about the total transcriptomic profile in healthy subjects after intake of fish oil compared to a control group. The objective was to examine the gene expression profile in peripheral blood mononuclear cells (PBMCs) in healthy subjects after intake of fish oil for seven weeks using whole-genome transcriptomic analysis. In a double-blinded randomized controlled study, healthy subjects received capsules containing either 8 g/d of fish oil (1.6 g/d EPA+DHA) (n=17) or 8 g/d of high oleic sunflower oil (n=19) for seven weeks. The results provide important information on how fish oil may modulate basic cellular processes involved in normal cell function and lymphocyte activation such as ER stress, cell cycle and apoptosis. The subjects were taking 16 capsules/d containing 8 g/d of either fish oil (FO) or high oleic sunflower oil (HOSO) for seven weeks. Subjects in the FO group received capsules containing 0.7 g/d EPA + 0.9 g/d DHA from cod liver oil (Gadidae sp., TINE EPADHA Oil 1200) provided by TINE SA (Oslo, Norway) and subjects in HOSO group received high oleic sunflower oil purchased from AarhusKarlshamn AB (Malmӧ, Sweden). Prior to the baseline visit (visit 2, wk 0), the subjects conducted a four-week washout period, where foods containing marine n-3 fatty acids were excluded from the diet. The first three weeks of the intervention period the subjects conducted a fully-controlled isocaloric diet, provided with all food and beverages at Akershus University College, Norway. During the last four weeks of the intervention the subjects returned to their habitual diet. Use of fish, fish products, marine n-3 enriched food or dietary supplements was not allowed during the entire study period of 11 weeks. The study was registered at www.clinicaltrial.gov (IDno. NCT01034423). The subjects met for four visits and blood samples for the transcriptome analyses were collected at wk 0, 3 and 7. After blood collection, PBMCs were isolated by using the BD Vacutainer Cell Preparation tubes according to the manufacturer's instructions (Becton, Dickinson and Company, NJ 07417, USA). Pellets were frozen and stored at -80o C for further RNA isolation.

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Thai cannabis practice patterns and quality of life study

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