Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Lung Neoplasms

Marijuana Abuse

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

blood and hair sampling

Pauline PRADERE, MD

Mihaela Aldea, MD

Cannabis is the most consumed drug in the world and the French are the main consumers in Europe. The most recognized effects of cannabis on human health are of a neuro-psychic nature. The medical literature on the effects of cannabis on the lung in general, and on lung carcinogenesis in particular, is most often reassuring (Tashkin, Chest 2018; Zhang, Int J Cancer 2015; Ghasemiesfe JAMA Netw. Open. 2019), despite the fact that the concentration of carcinogens in cannabis smoke is higher than that contained in tobacco smoke (Moir, Chem. Res. Toxicol. 2008), and that cannabis smoking has been implicated in the occurrence of ENT cancers. Rather, research focuses on the therapeutic effects of cannabis, especially analgesics, and even on its possible anti-tumor virtues (Abrams, Jama Oncol. 2020). These reassuring data should, however, be viewed with a great deal of caution. On the one hand, the illegal nature of cannabis in most countries and its frequent association with tobacco consumption make studies on the subject difficult and often biased. On the other hand, the daily practice of oncologists, who observe numerous cases of advanced and rapidly progressive lung cancer occurring in young patients who are heavy users of cannabis, raises suspicion of an unrecognized role of cannabis in lung carcinogenesis.

In a preliminary multicenter study on French patients under 50 years of age operated for primary lung cancer (Betser, ERJ 2021), we demonstrated that cannabis consumption was extremely frequent, concerning 43% of patients, but mentioned in patients' medical records only in 4 out of 10 cases, while the smoking status was always noted.

In addition, by comparing people who smoke cannabis (always here associated with tobacco) to patients who only smoke tobacco or to non-smokers, we identified a different profile of lung cancers, with more poorly differentiated tumors, presenting at a more advanced stage (more T3-T4 versus T1-T2) requiring more complex surgery, and mostly located in the upper lobes of the lung.

Similar research work is currently underway at Gustave Roussy (Dr Pradere-Dr Planchard, Villejuif, France) on patients with metastatic lung cancer, with a focus on overall survival and molecular profile.

Environment and Lung Cancer

Centre Chirurgical Marie Lannelongue

Symptoms and General Pathology

Nervous System Diseases

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Analgesics

All Drugs and Chemicals

Patients undergoing inpatient abdominal surgery for the treatment of cancer who self-report daily cannabis use

Patients undergoing inpatient abdominal surgery for the treatment of cancer who self-report no cannabis use

Camille Stewart

Nick Naughton

Camille Sterwart

To determine how daily cannabis use affects surgical outcomes.

To determine if patients who are daily cannabis users that are undergoing inpatient abdominal surgery for the treatment of cancer are different from non-cannabis users regarding phytocannabinoid and endocannabinoid levels, pain scores, pain medication requirements, and surgical complications.

Quantification of Cannabinoids and Comparison to Post-Surgical Pain Medication Requirements and Surgical Outcomes

Quantification of Endo- and Phytocannabinoids With Comparison to Pain Medication Requirements and Surgical Outcomes for Patients Undergoing Abdominal Surgery for Cancer

Postoperative opioid consumption among daily cannabis using and non-cannabis using patients undergoing abdominal surgery for cancer

Correlation between serum phytocannabinoid and endocannabinoid levels, pain scores, and postoperative opioid consumption

Correlation between 30-day post-operative complications, preoperative, and postoperative phytocannabinoid and endocannabinoid levels

National Cancer Institute (NCI)

University of Colorado, Denver

Musculoskeletal Diseases

Rare Diseases

Chronic Pain

Musculoskeletal Pain

Muscular Diseases

Chronic Graft Versus Host Disease

Edeltraut Kröger, Ph.D.

Lise Poisblaud

Despite many pharmaceutical options, there are no optimal treatments for Chronic musculoskeletal pain (CMP). Although many Canadians use medical cannabis (MC; legally authorized) to relieve their pain, there are no firm conclusions on the efficacy and safety of MC against CMP. In order to increase knowledge on this topic, it is essential to describe the current use of MC against CMP by Canadians and to understand patients' and physicians' perceptions and attitudes. Objectives: This study will evaluate the use of MC against CMP among adults and aims at: 1-Describing the use of MC in Canada, and the main characteristics of users and prescribers; 2-Identifying the therapeutic and adverse effects of MC from the users' perspective; 3a- Identifying the psychosocial, organizational, socio-demographic and health-related factors that influence the use and prescription of MC; and 3b- Quantifying the impacts of these factors on the use and prescription of MC in the management of CMP. Methods: 1) We will analyse available data on the users and prescribers of MC from Health Canada and from the Registre Cannabis Québec; 2) We will use mixed methods to collect data from patients affected by CMP and their physicians. Data from Health Canada will allow to document the prevalence and recent evolution of MC use. The qualitative phase of the second part of the study will identify obstacles and facilitators for the use AND for the prescribing of MC against CMP, including the need for more information in patients suffering from CMP and in physicians. Reasoned samples of patients and physicians will be recruited; information will then be collected by semi-structured interviews. For the quantitative phase, a pan-Canadian survey will be conducted, using a questionnaire built with the results of the qualitative phase of the study. The proposed study will describe the current use of MC against CMP in Canada and will allow to better understand the motivations and expectations of physicians and patients.

Chronic musculoskeletal pain (CMP) is very frequent among Canadians. Pharmacological treatment options for CMP are limited, and some of them (e.g. opioids) have important adverse effects if taken for a long time. Cannabis destined for therapeutic use ("medical cannabis" - MC) could represent an interesting alternative therapeutic option for CMP; it attracts more and more attention, particularly with the legalisation of recreational cannabis in October 2018. However, past research, including that of a team member1-4 and a scoping literature review5,6 from our team, revealed severe knowledge gaps regarding many aspects of the utility and conditions of use of MC in the management of CMP, such as its effectiveness, safety, routes of administration, delivery methods, dosage, etc. The fact that cannabis is also used recreationally and linked to a strong user stigma complicates both the conduct of rigorous randomized controlled trials and the conclusions which can be drawn from prior research. We propose as a first step for the development of knowledge on the use of MC to relieve CMP to study current MC users and prescribers, as well as their personal experiences with and perceptions of MC. This will improve both continuous education for prescribers and knowledge exchange with users. The new knowledge will pave the way to the design of research trials that with improved, less biased recruitment, and a follow-up of larger numbers of participants, which in turn would improve the validity and generalisability of the results of such trials. It will thus facilitate rigorous clinical trials, which are absolutely necessary in order to develop sufficient knowledge on this topic. To this end, we propose a mixed methods study that will aim to: 1)Describe the use of MC in the management of CMP in Quebec and Canada, its recent evolution as well as the main characteristics of its users and prescribers; 2)Identify the therapeutic and adverse effects of MC as experienced by patients with CMP enrolled in the QCR; 3a)Identify the psychosocial, organizational, sociodemographic and disease-related factors influencing MC use in patients and prescribers; and 3b)Quantify the influence of these factors on the use of MC in the management of CMP.

The proposed study will use mixed, quantitative and qualitative, methods. The first component (Objectives 1 and 2) will take advantage of Canadian databases, including the QCR, to describe the extent of MC use in Canada, MC authorised users and their prescribers. The second component (Objectives 3a and 3b) will use a qualitative and quantitative methodology to identify the factors influencing the use of MC by patients suffering from CMP and the prescription of MC by their doctors. The new scientific knowledge generated by this study will be shared in the form of publications, policy briefs to guide patients and prescribers on the use of the MC in the management of CMP and recommendations guiding the conduct of rigorous clinical trials that will take into account the needs of Canadian patients and physicians.

In order to benefit from the presence of experts who will be able to guide and orient the work, validate the research results and facilitate the appropriation and exchange of knowledge, a steering committee will accompany the research activities from the onset of the second part of the study. This committee will be composed of clinicians anaesthesiologists, family physicians, pharmacists, rheumatologists), of patients suffering from CMP who are using and not using MC, of representatives of CMP societies (e.g.

The Arthritis Society), of decision-makers (ICES, INESSS, INSPQ), of the cannabis industry (e.g. Canopy Growth Corporation) and of researchers from the team. Professionals from the SRAP ("Strategy for Patient-Oriented Research") initiative of CIHR will accompany the team for the final identification of committee members, particularly patient members. A knowledge broker will be in charge of the animation of these meetings. This person will be responsible for the main aspects of knowledge translation, i.e. the preparation of the communication strategies with the different audiences. Three meetings are planned, during pivotal moments of the project: Meeting 1: Component 1 review (presentation of Component 1 results) / initiation of Component 2: validation of the research strategy for the collection of exploratory qualitative data (interview guide); Meeting 2: Presentation of the results of the qualitative component (Objective 3a) / Work on the research strategy for collecting quantitative data (questionnaire) (Objective 3 b); Meeting 3: Members will work on the recommendations and guidance notes for knowledge translation.

The proposed study aims to describe the current use of CM against CMP in Quebec and Canada and will help to better understand the motivations and expectations of physicians and patients. This new knowledge will enable the design of future high quality RCTs and provide stakeholders with guidelines for the use of MC for musculoskeletal pain.

Medical Cannabis Against Chronic Musculoskeletal Pain: a Mixed Methods Study.

Medical Cannabis Against Chronic Musculoskeletal Pain: a Mixed Methods Study to Describe Use and to Identify Its Facilitators and Barriers Among Canadian Patients and Doctors

Describe the current use of MC against CMP

Describe the current authorization of MC against CMP

McGill University

Université de Sherbrooke

CHU de Quebec-Universite Laval

Research Scientist, Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale

Nutritional and Metabolic Diseases

Respiratory Aspiration

Disease Progression

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

PPP011 (synthetic THC/CBD) inhalation with mighty medic device

Placebo inhalation with mighty medic device

1 capsule inhaled 3 times a day with a vaporizer device

PPP011

Placebo

Martin Chasen, MD

A large number of patients with advanced cancer also suffer from cachexia. Cachexia is a syndrome characterized by loss of skeletal muscle mass (with/or without loss of fat mass) that cannot be reversed by nutritional support and progressively leads to functional impairment. Patients who suffer from anorexia and cachexia have lower survival rates. Some patients with cancer use cannabis to improve the way they feel and relieve their pain. However, there is very sparse high-quality research to prove that cannabis products are truly effective. This study will investigate patients with advanced cancer who use inhaled therapeutic cannabinoid-based medication (PPP011), in addition to palliative care management, and will assess if these patients experience improvement in functional status as a surrogate endpoint for survivalquality

This is a 12-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP011 on physical functioning and cachexia progression in patients with cachexia related to advanced incurable cancer.

Safety and Efficacy of Inhaled Synthetic THC/CBD for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia

Safety and Efficacy of PPP011-kit for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia: a Randomized, Double Blind, Placebo Controlled, Parallel Group Study

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). items are rated on a scale of 1 (not at all) to 4 (very much). high scores on a symptom scale correlate to increased symptom burden

Downgrading cachexia grade or grade maintenance will be considered as a drug benefit.

using a visual analogue scale. horizontal 0-100 mm VAS assessing pain

Patient-generated-subjective global assessment (PG-SGA) where critical need for nutrition intervention is defined as having a score ≥ 9 The higher the score the greater the risk for malnutrition

Tetra Bio-Pharma

Cancer Pain

Quality of Life

Acute Graft Versus Host Disease

PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device

1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device

PPP001

1 placebo dosing capsule inhaled 3 times a day with a vaporizer device

Tetra Bio Pharma

Suzanne Sisley, MD

This phase 2 multicenter clinical trial assess the safety and efficacy of inhaled PPP001 to relieve the pain in 78 advanced cancer patients with uncontrolled symptoms. This is a 4-week treatment period study followed by an open label period of 1 year.

This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 on uncontrolled cancer pain in patients with symptoms related to advanced incurable cancer.

Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer

SAFETY AND EFFICACY OF PPP001-kit FOR THE UNCONTROLLED PAIN RELIEF IN PATIENTS WITH ADVANCED CANCER: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). single-item scale is rated from 1 (very poor) to 7 (excellent). High scores on a functional scale correspond to better functioning

Revised Edmonton Symptom Assessment System (ESAS-r-CS). 11 core symptoms: pain, tiredness, nausea, depression, anxious, drowsiness, appetite, feeling of well-being, shortness of breath, constipation and trouble sleeping. 11-point NRS ranging from 0 (no symptom) to 10 (worst possible).

palliative performance scale version 2 (PPSv2) for measuring functional status in end-of-life patients. A healthcare professional scores each dimension by assigning a value from 100% to 0% (death), with 10% denoting the lowest level of functioning

The treatment satisfaction questionnaire (change version) will be used. Scale range is a left to right 7-item scale for caregiver. each item is scored from 5 (Much more satisfied now) to 1 (Much Less satisfied now).

distress thermometer adopted as a screening measure to identify and address psychological distress in individuals with cancer. Results support a cut-off score of 3 on the DT to indicate patients with clinically elevated levels of distress .

This intervention includes different asynchronous pedagogical modalities that allow, among other things, to reactivate the participants' previous knowledge and promote their autonomy in their learning process. These modalities focus on various problems that oncology nurses may encounter about the use of cannabis in oncology (eg, how to tackle the subject, what are the correct times to approach the topic). To this end, various pedagogical modalities that encourage the active participation of nurses are integrated into the training (eg, interactive videos, and quizzes). Scientific articles and links to external resources (official public websites) are also included so that nurses can consult the content at their own pace. Different aspects related to the use of cannabis are addressed in the training (eg, beneficial effects, and potential side effects).

The comparator is composed of an email with basic reliable non-personalized information on cannabis use in oncology (official public websites and scientific articles).

The Cannabis \& Cancer intervention is available on Moodle learning management system in French language. It aims to influence nurses' self-efficacy, attitudes, intentions, and knowledge regarding the safe and efficient use of cannabis by young adults diagnosed with cancer.

Cannabis & Cancer digital educational intervention

Participants will be offered basic reliable non-personalized information on cannabis use in oncology (official public websites and scientific articles).

Standard information regarding cannabis use in oncology

Karine Bilodeau, PhD

José Côté

Billy Vinette, MSN

The purpose of this study is to evaluate the preliminary effects and impacts of a digital educational intervention to support nurses' professional practice regarding safe cannabis use by young adults (18-39 years) diagnosed with cancer.

This online pilot randomized controlled trial with parallel groups is conducted in Quebec (Canada). Moodle learning management system will be used to train nurses working in oncology.

After accepting the conditions and consenting, participants will enroll in the study by providing an email address. Each participant will be validated through an email address check. After their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire.

After completing the baseline questionnaire, participants will be randomly assigned by a research assistant to the digital educational intervention (Cannabis \& Cancer) or to a control group (official public websites and scientific articles).

Four weeks after the baseline questionnaire, participants will complete the online questionnaires again.

Cannabis and Cancer, an Online Training for Oncology Nurses

Evaluation of a Digital Educational Intervention Regarding Safe and Efficient Cannabis Use With Young Adults Diagnosed With Cancer: a Pilot Study

The French version of the Continuing Professional Development Reaction (CPD-Reaction) questionnaire (Légaré et al., 2014) will be used. The CPD-Reaction is a 12-item theory-based self-report questionnaire designed to assess the impact of continuing professional development on different clinical practices and can be modified according to the behavior targeted by the continuing professional activity (ie, the Cannabis \& Cancer intervention).

It is scored using a seven-point Likert scale ranging from strongly disagree (1) to strongly agree (7). The total score can range from 3 to 21 for self-efficacy. Higher scores indicate higher levels of self-efficacy. The CPD Reaction has adequate test-retest reliability (ie, weighted kappa coefficient between 0.43-0.53 for self-efficacy). The questionnaire has good internal consistency (Cronbach's alpha = 0.84).

The French version of the Continuing Professional Development Reaction (CPD-Reaction) questionnaire (Légaré et al., 2014) will be used. The CPD-Reaction is a 12-item theory-based self-report questionnaire designed to assess the impact of continuing professional development on different clinical practices and can be modified according to the behavior targeted by the continuing professional activity (ie, the Cannabis \& Cancer intervention).

It is scored using a seven-point Likert scale ranging from strongly disagree (1) to strongly agree (7). The total score can range from 2 to 14 for attitudes. Higher scores indicate more favorable attitudes toward the behavior. The CPD Reaction has adequate test-retest reliability (ie, weighted kappa coefficient between 0.5-0.54 for attitudes). The questionnaire has good internal consistency (Cronbach's alpha = 0.89).

The French version of the Continuing Professional Development Reaction (CPD-Reaction) questionnaire (Légaré et al., 2014) will be used. The CPD-Reaction is a 12-item theory-based self-report questionnaire designed to assess the impact of continuing professional development on different clinical practices and can be modified according to the behavior targeted by the continuing professional activity (ie, the Cannabis \& Cancer intervention).

It is scored using a seven-point Likert scale ranging from strongly disagree (1) to strongly agree (7). The total score can range from 2 to 14 for intention. Higher scores indicate higher intentions to perform the behavior. The CPD Reaction has adequate test-retest reliability (ie, weighted kappa coefficient between 0.54-0.6 for intention). The questionnaire has good internal consistency (Cronbach's alpha = 0.79).

Nurses' knowledge will be assessed using a seven-point Likert scale (ie, 1=strongly disagree and 7=strongly agree) to be developed by the research team based on the educational content presented in the training.

Objective data. This data will be collected automatically when users log into the learning management system.

Subjective engagement (self-reported) will be measured using the validated French version (Fontaine et al., 2020) of the User Engagement Scale - Short Form (UES-SF) (O'Brien et al., 2018). This 12-item instrument serves to measure four dimensions of engagement: 1) aesthetic appeal; 2) focused attention; 3) perceived usability, and 4) reward factor. Possible answers range from strongly disagree (+1) to strongly agree (+5). The possible total score ranges between 12 and 60. The score for each item will be interpreted and the scores for each dimension will be compared to indicate which are rated more highly than others. The French version shows acceptable internal consistency (ie, McDonald's omega coefficients ranging from 0.77-0.89).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Environment and Lung Cancer	NCT05119244	Cannabis Use	blood and hair ...	18 Years - 59 Years	Centre Chirurgical Marie Lannelongue
Quantification of Cannabinoids and Comparison to Post-Surgical Pain Medication Requirements and Surgical Outcomes	NCT04988490	Post-Surgical P... Post-Surgical C... Cancer Cannabis Use		21 Years -	University of Colorado, Denver
Medical Cannabis Against Chronic Musculoskeletal Pain: a Mixed Methods Study.	NCT05210660	Musculoskeletal... Cannabis Use		18 Years -	CHU de Quebec-Universite Laval
Safety and Efficacy of Inhaled Synthetic THC/CBD for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia	NCT04001010	Cannabis Use Cachexia; Cance... Advanced Cancer	PPP011 Placebo	18 Years -	Tetra Bio-Pharma
Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer	NCT04042545	Cancer Pain Quality of Life Pain, Acute Cannabis Use	PPP001 Placebo	18 Years -	Tetra Bio-Pharma
Quantification of Cannabinoids and Comparison to Post-Surgical Pain Medication Requirements and Surgical Outcomes	NCT04988490	Post-Surgical P... Post-Surgical C... Cancer Cannabis Use		21 Years -	University of Colorado, Denver
Environment and Lung Cancer	NCT05119244	Cannabis Use	blood and hair ...	18 Years - 59 Years	Centre Chirurgical Marie Lannelongue
Cannabis and Cancer, an Online Training for Oncology Nurses	NCT05663346	Cannabis Use Cannabis Use, U... Nurse's Role Oncology Pain Symptoms and Si...	Cannabis & Canc... Standard inform...	18 Years - 70 Years	Ciusss de L'Est de l'Île de Montréal

Spots Global Cancer Trial Database for cannabis use

Every month we try and update this database with for cannabis use cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.