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2019-12-16
2024-09-25
2024-09-25
109
NCT03984214
Arbeitsgemeinschaft medikamentoese Tumortherapie
Arbeitsgemeinschaft medikamentoese Tumortherapie
INTERVENTIONAL
Efficacy and Safety of Dronabinol in the Improvement of Chemotherapy-induced and Tumor-related Symptoms in Advanced Pancreatic Cancer
Aim of this phase III trial is to investigate the efficacy and safety of dronabinol (orally administered tetrahydrocannabinol (THC)) as adjuvant therapy to first-line standard chemotherapy in patients with metastatic pancreatic cancer for improvement of chemotherapy- and tumor-related symptoms applicated by individual titration up to the maximum tolerated dose.
Patients with pancreatic cancer suffer from multiple symptoms related to the tumor itself or induced by the chemotherapy. The available supportive therapy is still not able to relief all symptoms that are caused by the malignancy itself as well as by the antineoplastic therapy. Additionally, anorexia and weight loss, that often result in increased morbidity and mortality in this patient population as well as in psycho-social burden and suffering in patients and their relatives, are unmet needs in pancreatic cancer patients. Therapeutic approaches focus on treating the malignancy itself, additional nutritional support and physical examination might prevent patients from further side effects such as sarcopenia. During the last decades a number of appetite-modulating drugs have been under clinical investigation. A number of studies focused on the endocannabinoid system, which is involved amongst others in appetite-modulating, antiemetic, analgesic and anti-inflammatory processes. As dronabinol is already used as magistral formulation, its beneficial effect has often been observed in these patients in the clinical routine, especially in patients with therapy-refractory nausea and emesis. Due to its broad efficacy it might be of benefit for patients suffering from malignancy. Thus, investigators want to evaluate the efficacy of dronabinol in the improvement of chemotherapy-induced and tumor-related symptoms in advanced pancreatic patients during systemic first-line chemotherapy. However, data on optimal dosage are conflicting yet. In detail, investigators want to study whether dronabinol has a positive influence on quality of life and whether symptoms caused by the tumor or by the chemotherapy itself might be palliated by dronabinol. Beneficial and potential harmful side effects and the personal perception of advanced pancreatic cancer patients will be documented.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-05-28 | N/A | 2025-04-09 |
2019-06-11 | N/A | 2025-04-10 |
2019-06-12 | N/A | 2024-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Dronabinol BX-1 contains 25 mg dronabinol/ml (2.5% delta-9-trans-tetrahydrocannabinol = THC), oral solution; three applications per day from 2.5 mg (3 x 1 droplet) up to 30 mg (3 x 12 droplets) | DRUG: Dronabinol in Oral Dosage Form
|
| PLACEBO_COMPARATOR: Placebo Placebo: oral solution with cannabis flavor without active substance and otherwise identical to active comparator, three applications per day from 3 x 1 droplet up to 3 x 12 droplets | DRUG: Placebo in Oral Dosage Form
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Standardized area under the curve of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 symptom summary score over the on-treatment period. | The EORTC-QLQ-C30 is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials. The validated QLQ-C30 summary score is calculated as mean score of the 13 of the 15 EORTC QLQ-C30 scales (v3.0), based on 27 of 30 items (the Financial Impact scale and Quality of Life score are not included). A high score for a symptom scale / item (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea) represents a high level of symptomatology / problems. A high score for a functional scale (physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning) represents a high / healthy level of functioning. Scores for individual items: "Not at All" = 1 point, "A Little" = 2 points, "Quite a Bit" = 3 points, "Very Much" = 4 points. A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100. | Prior to treatment start until end of 16 weeks maintenance treatment |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Standardized area under the curve of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 symptom summary score over the maintenance period | The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials. The validated QLQ-C30 summary score is calculated as mean score of items. A high score for a symptom scale / item (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea) represents a high level of symptomatology / problems. Scores for individual items: "Not at All" = 1 point, "A Little" = 2 points, "Quite a Bit" = 3 points, "Very Much" = 4 points. A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100. | After 4 weeks of treatment until week 16 |
| Change of European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 symptom summary score from baseline to summary score over the maintenance period | The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials. The validated QLQ-C30 summary score is calculated as mean score of items. A high score for a symptom scale / item (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea) represents a high level of symptomatology / problems. Scores for individual items: "Not at All" = 1 point, "A Little" = 2 points, "Quite a Bit" = 3 points, "Very Much" = 4 points. A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100. | From treatment start until week 16 |
| Symptom scales of European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 | A high score for a symptom scale / item (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea) represents a high level of symptomatology / problems. Scores for individual items: "Not at All" = 1 point, "A Little" = 2 points, "Quite a Bit" = 3 points, "Very Much" = 4 points. A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100. | At baseline and 2-weekly until end of treatment at week 18 |
| Global quality of life of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 | The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials. The validated QLQ-C30 summary score is calculated as mean score of items. A high score for the global health status (overall health during the past week) and global QoL (overall quality of life during the past week) represents a high QoL. Scores: 1 - 7, 1 = very poor and 7 = excellent. A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100. | At baseline and 2-weekly until end of treatment at week 18 |
| Functional scales of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 | The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials. A high score for a functional scale (physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning) represents a high / healthy level of functioning. Scores for individual items: "Not at All" = 1 point, "A Little" = 2 points, "Quite a Bit" = 3 points, "Very Much" = 4 points. A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100. | At baseline and 2-weekly until end of treatment at week 18 |
| Mean change from baseline of the Glasgow Prognostic Score | Change of serum levels of the score-defining biomarkers C-reactive protein (CRP) and albumin. Prognostic scores; 0 (CRP ≥ 10 mg/l), 1 (CRP > 10 mg/l and albumin ≥ 35 g/l), 2 CRP > 10 mg/l and albumin < 35g/l). Score 0 indicates good prognosis, score 1 intermediate prognosis and score 2 poor prognosis. | At baseline and at end of treatment at week 16 |
| Amount of concomitant medication taken | Special focus on antiemetic, psychotropic and pain medication | From baseline until end of treatment at week 18 |
| Mean time to critical weight-loss (5%) | Assessed with a standard scale | From baseline until end of treatment at week 16 |
| Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Lean body mass (LBM) | Mean change of Lean body mass (LBM = Fat free mass FFM) kg | At baseline and at end of treatment at week 16 |
| Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Total body water (TBW) | Mean change of Total body water (TBW) kg | At baseline and at end of treatment at week 16 |
| Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Fat mass (FM) | Mean change of Fat mass (FM) kg | At baseline and at end of treatment at week 16 |
| Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Body cell mass (BCM) | Mean change of Body cell mass (BCM) kg | At baseline and at end of treatment at week 16 |
| Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Extracellular mass (EM) | Mean change of Extracellular mass (ECM) kg | At baseline and at end of treatment at week 16 |
| Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Phase angle (PA) | Mean change of Phase angle (PA); Phase Angle has long been linked to nutritional status. This marker is fast becoming recognised as a global health marker in total body health assessment. A higher Phase Angle could mean an increase in muscle mass (body cell mass) or a decrease in fluid, either from recovery from infection or injury (a good thing!) or a decrease in fluid from dehydration (a bad thing!). A loss of fat could also increase Phase Angle. A lower Phase Angle could mean a loss of muscle mass (a bad thing), or an increase of fluid (rehydrating which is a good thing, or sign of inflammation or infection - a bad thing), or gaining fat (which could be a good or bad thing depending on your state of health). Phase Angle is a direct measurement, (not a calculation using equations) of the cell membrane. | At baseline and at end of treatment at week 16 |
| Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Resistance (Rz) | Mean change of Resistance (Rz), unit ohm; the resistance reflects the water or fluid in the body | At baseline and at end of treatment at week 16 |
| Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Reactance(Xc) | Mean change of Reactance (Xc), unit ohm; reactance reflects the body cell mass. | At baseline and at end of treatment at week 16 |
| Mean change from baseline of muscle strength | To assess physical strength of patient's handgrip strength will be measured prior and after study treatment using a hydraulic hand dynamometer; mean value of three consecutive measurements will be documented | At baseline and at end of treatment at week 16 |
| Proportion of patients not adhering to individual baseline chemotherapy regimen | Percentage of patients who do not receive full dose of planned chemotherapy regimen and/or within scheduled time frame (interruption or delay) | From baseline until end of treatment at week 18 |
| Chemotherapeutic dose intensity over the treatment period of 18 weeks | The total amount of applied chemotherapy over the study treatment phase is documented | From baseline until end of treatment at week 18 |
| Frequency and severity of (serious) adverse events (S)AE | Assessed with Common Terminology Criteria for Adverse Events (NCI-CTCAE V5.0) | From baseline until safety visit at week 22 |
| Incidence of adverse drug reactions (ARs) | Frequency and severity of ARs | From baseline until safety visit at week 22 |
| Progression-free survival (PFS) | PFS in months; ; patients will be asked to agree on collection of data regarding PFS also after end of trial | From treatment start until the date of first documented progression or death from any cause assessed up to week 22 |
| Overall survival (OS) | OS in months; ; patients will be asked to agree on collection of data regarding PFS also after end of trial | From treatment start until death from any cause assessed up to week 22 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
