Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Chronic Pain

Cancer Pain

Pain

Marijuana Abuse

Neurologic Manifestations

Quality of Life

Chronic Graft Versus Host Disease

280 mg dried cannabis pellet -(9% THC / 2% CBD per pellet)

280 mg dried extracted cannabis pellet (0% THC / 0.6% CBD per pellet)

1 pellet smoked three times a day with titanium pipe (280 mg dried cannabis pellet - 9% THC / 2% CBD per pellet)

PPP001

1 pellet smoked three times a day with titanium pipe (280 mg dried cannabis pellet - 0% THC / 0.6% CBD per pellet)

placebo

Antonio Vigano, MD, MSc

Cancer causes pain in many of the patients that it affects. Physicians specialized in palliative care help advanced cancer patients to maintain as good pain control as possible through the use of medications such as opioids. Even with palliative care and optimal use of medications, many patients still suffer enormously as the cancer spreads. Because of this, some cancer patients also try or use cannabis in different ways to relieve their pain and improve the way they feel. However, there has not been much high-quality research done yet to prove whether or not cannabis products are truly useful to relieve severe cancer pain. This study is to test if advanced cancer patients who use inhaled medical cannabis (PPP001), in addition to palliative care management, will experience improvement in quality of life and relieve uncontrolled pain, providing safety conditions.

This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 to improve quality of life (HRQoL) and reduce pain intensity, in patients with uncontrolled cancer pain and incurable malignancy.

Nine hundred forty six adult patients, male and female, with chronic cancer pain (at least 3 months in duration) and advanced disease, with an average weekly pain intensity score greater than 4 on a 11 points Numerical Rate Scale (NRS), will be prospectively recruited and invited to participate in this trial.

Informed consent will be obtained by a Research Assistant.

After baseline documentation with standardized scales, patients will be randomized to one of 2 parallel groups:

Group A: 4 weeks PPP001-kit three times daily; Group B: 4 weeks placebo-kit three times daily; The inhalation of PPP001 or placebo-kit will be allowed three times a day at 4-6 hour intervals. Rescue medication will also be allowed.

Patients will have a dose titration phase during the first week, followed by an additional 3-week period of treatment. The dose escalation will allow patients to adapt to the potential AEs of cannabis.

Patients will have follow-up after 1 week and 4 weeks of treatment. Once the patient has completed 4 weeks of inhaled PPP001 or placebo, it will be rolled into a long-term follow-up phase until drop-out or death. All patients, including the ones in the placebo group, will be allowed to receive the active treatment once the 4-weeks trial has finished, and continue it until death or drop-out.

Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients

Safety and Efficacy of PPP001-kit for Improving Health Related Quality of Life in Advanced Cancer Patients With Uncontrolled Pain: A Randomized, Double-blind, Placebo-Controlled, Parallel Group Study

Does the daily use of PPP001-kit improve European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). Scale range is 1 to 4; 1 (Not at All) being the worst rating to the maximal rating of 4 (Very Much).

Changes in pain as measured by the Brief Pain Inventory-Short Form (BPI-SF) scale. Scale range is 0 to 10; 0 (No pain) being the best rating to the maximal rating of 10 (Pain as bad as you can imagine).

Changes in symptom burden as measured by the revised Edmonton Symptom Assessment System version with Constipation and Sleep was added to assess improvement in symptom burden (ESAS-r-CS). Scale range is 0 to 10; 0 (No symptom) being the best rating to the maximal rating of 10 (Worst possible score for symptom).

Changes in Palliative Performance Scale (PPSv2) version 2. Scale range is a left to right and downward scale for participant to find the best description of their palliative performance. Worst being 0% score representing Dead to PPS 100% representing Full ability to interact and function.

Changes in Caregivers Quality of Life Index- Cancer (CQOLC). Scale range is 0 to 4; 0 meaning Not at All affected and 4 meaning Very Much affected.

Changes in validated Udvalg for klinische Undersøgelser (UKU) Side Effects Rating Scale, Self-rating version for Patients (UKU-SERS-Pat). Scale range is 0 to 3 for rating the degree of severity and a second scale for the investigator that assigns a casual relationship of improbable, possible or probable.

Changes in validated Mini-Cog. Scale range is numerical and rates the ability to recall words and ability to draw a clock showing numbers from 1 to 12 and then drawing the given time.

Changes in a 100-mm VAS of good drug effect, and a VAS for the items "high," "relaxed," "stressed," and "happy" (0 = not at all, 10 = extremely)

Changes in concurrent medications will be measured using the Medication Quantification Scale (MQS) version III. The MQS version III is a method of quantifying different pain drug regimens by evaluating the use of 22 distinct drug classes (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\], antidepressants, benzodiazepines, opiates). A single value is calculated based on a patient's pain medication profile, taking into account dosages, and the types of pain medications prescribed.

Changes in validated European Quality of Life-5 Dimensions (EQ-5D). First scale range provides 5 statements that describe the participants health TODAY; it includes 5 different health assessments. The second scale is 0 to 100 and requires that the participant places a mark on the scale showing how good or bad they feel TODAY; 0 meaning The worst health they can imagine; 100 meaning the best health they can imagine.

Changes in pain as measured by the Numerical Rating Scale (NRS). The NRS is a measure of the average weekly pain intensity score greater than on a 0 to 10 points scale where 0 is No Pain and 10 is the worst pain.

Changes in validated Memorial Delirium Assessment Scale (MDAS). Scale range is 0 to 3; 0 meaning None and 3 meaning Severe.

Rescue medication will be based on the calculation of 10% of the total morphine equivalent daily dose (MEDD). The reduction or increase in the total MEDD will be recorded after starting treatment with PPP001.

Tetra Bio-Pharma

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Aspiration

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

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

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

Placebo

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). 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

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 .

Breakthrough Pain

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Oxycodone

Morphine

Hydromorphone

Analgesics, Opioid

Narcotics

Oral morphine sulfate or hydromorphone or oxycodone at the previous stabilized dosage

Group assigned to morphine sulfate or hydromorphone or oxycodone

Morphine sulfate or Hydromorphone or Oxycodone

Mitchell Hassman, MBA

Mitchell Hassman

Breakthrough cancer pain (BTcP) is a rapid onset, high intensity and short duration pain episode, which takes place within stable background pain control. It significantly affects the quality of life of patients with cancer and their ability to function normally. Rapid onset opioids and immediate-release oral opioids (e.g. morphine sulfate, hydromorphone, and oxycodone) are the standard treatment for BTcP. Because of the limited availability, high cost, complicated titration and the high risks of overdosing with rapid-onset opioids, most often the preferred choice of treatment is immediate-release oral opioids. However, this approach might not always offer optimal speed for onset of action and duration to match the rapid nature of an episode of BTcP. In order to seek a potential alternative to immediate-release oral opioids, we are proposing to test the onset of action of PPP001 to rapidly alleviate breakthrough pain in patients with cancer. We will also examine the safety and the efficacy on pain intensity of PPP001 within this population.

The study is a randomized, open-label crossover comparison study: This will be a 10-week open-label randomized study to evaluate the effect of inhaled PPP001 as compared to morphine sulfate or hydromorphone or oxycodone to improve for the treatment of BTcP. After proper screening and verified inclusion/exclusion criteria, 20 consecutive subjects will be recruited.

Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain

Inhaled PPP001 Versus Immediate-release Oral Opioids for the Management of Breakthrough Pain in Cancer Subjects: a Randomized, Open Label, Crossover, Comparison Study

SPID30 score after PPP001 administration or immediate-release oral opioids (morphine sulfate or hydromorphone or oxycodone) administration. The SPID30 calculation is based on a 100 mm pain intensity VAS were 0 mm is the minimum and 100 mm the maximum with higher score representing a worse outcome.

SPID score after PPP001 administration or immediate-release oral opioids (morphine sulfate or hydromorphone or oxycodone) administration. The SPID calculation is based on a 100 mm pain intensity VAS were 0 mm is the minimum and 100 mm the maximum with higher score representing a worse outcome.

PID score after PPP001 administration or immediate-release oral opioids (morphine sulfate or hydromorphone or oxycodone) administration. The PID calculation is based on a 100 mm pain intensity VAS were 0 mm is the minimum and 100 mm the maximum with higher score representing a worse outcome.

Subjective pain relief evaluated with a self-administered scale. The pain relief is measured with a five-point scale (0 = none to 4 = complete relief) with a higher score representing a better outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients	NCT03339622	Cancer Chronic Pain Du...	PPP001 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
Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain	NCT03564548	Cancer Breakthrough Ca...	PPP001 Morphine sulfat...	18 Years -	Tetra Bio-Pharma
Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients	NCT03339622	Cancer Chronic Pain Du...	PPP001 placebo	18 Years -	Tetra Bio-Pharma
Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients	NCT03339622	Cancer Chronic Pain Du...	PPP001 placebo	18 Years -	Tetra Bio-Pharma

Spots Global Cancer Trial Database for ppp001

Every month we try and update this database with for ppp001 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.

Spots Global Cancer Trial Database for ppp001

Every month we try and update this database with for ppp001 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.

Every month we try and update this database with for ppp001 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.