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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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This protocol describes a phase II trial investigating the efficacy of CBD in paclitaxel- and oxaliplatin-induced peripheral neuropathy. The trial uses multiple assessments such as validated PRO-questionnaires and multifrequency vibrometry.
Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to omission or even discontinuation of antineoplastic drugs, possibly affecting efficacy of cancer treatment. There is a lack of knowledge about the natural course of CIPN and to this date, there are no available methods for the early detection of CIPN. With no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | Patients will receive cannabidiol in conjunction with their standard chemotherapy treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol 100 MG/ML | Drug | Patients receive cannabidiol before and after treatment with chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy. | Difference in the North Central Cancer Treatment Group (NCCTG)- acute-CIPN Questionnaire from baseline compared to 3-5 days after initiation of chemotherapy course no. 1. The Questionnaire contains single items questions, answerable on a 0-10 numeric scale, 0 corresponds to no symptoms and 10 worst possible symptoms. | up to 5 days |
| Difference in Vibrograms from baseline and during 1. course chemotherapy. | Difference in the Vibrograms from baseline compared to 3-5 days after initiation of chemotherapy course no. 1. | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in baseline vibrograms of patients treated with CBD compared to vibrograms at follow-up 3 mo. after the end of the 6th course of chemotherapy or the last course of chemotherapy (if before course no. 6). | For patients receiving paclitaxel-based chemotherapy | through study completion, an average of 1 year and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects (Clinician Scored) | Side effects will be registered and scored according to the Common Terminology Criteria for Adverse Events v4.03 (CTCAE v4.03). The CTCAE grades side effects on a 1-5 scale. 1 represents best symptom manifestation and 5 represents death from specific side effect. | through study completion, an average of 1 year and 6 months |
Inclusion Criteria:
Exclusion Criteria:
CTFG: The Heads of Medicines Agencies commissioned Clinical Trials Facilitation Group under the European Union's clinical trials directive 2001/20.
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| Name | Affiliation | Role |
|---|---|---|
| Jørn Herrstedt, DMSc | Zealand University Hospital / University of Copenhagen | Study Chair |
| Sebastian W Nielsen, MD | Zealand University Hospital / University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology and Palliative Care | Roskilde | 4000 | Denmark |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Difference in baseline vibrograms of patients treated with CBD compared to vibrograms at follow-up 3 mo. after the end of the 4th course of chemotherapy or the last course of chemotherapy (if before course no. 4) |
For patients receiving oxaliplatin-based chemotherapy |
| through study completion, an average of 1 year and 6 months |
| Difference in CIPN from baseline to after chemotherapy course no. 3 | For patients receiving paclitaxel: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) from baseline compared to after chemotherapy course no. 3. The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72. | through study completion, an average of 1 year and 6 months |
| Difference in CIPN from baseline to after chemotherapy course no. 6 | For patients receiving paclitaxel: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) EORTC-QLQ-CIPN20 from baseline compared to after chemotherapy course no. 6. The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72. | through study completion, an average of 1 year and 6 months |
| Difference in CIPN from baseline to 1. follow-up (PAC) | For patients receiving paclitaxel: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) from baseline compared to 1. Follow-up, 3 mo. after chemotherapy. The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72. | through study completion, an average of 1 year and 9 months |
| Difference in CIPN from baseline to after chemotherapy course no. 2 | For patients receiving oxaliplatin: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) from baseline compared to after chemotherapy course no. 2. The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72. | through study completion, an average of 1 year and 6 months |
| Difference in CIPN from baseline to after chemotherapy course no. 4 | For patients receiving oxaliplatin: Difference in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) from baseline compared to after chemotherapy course no. 4. The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72. | through study completion, an average of 1 year and 6 months |
| Difference in CIPN from baseline to 1. follow-up (OX) | For patients receiving oxaliplatin: Difference in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy Questionnaire Module (EORTC-QLQ-CIPN20) from baseline compared to 1. Follow-up, 3 mo. after chemotherapy. The EORTC-QLQ-CIPN20 is a validated 20-item patient reported outcome questionnaire. Items are answered on a scale from 1-4. 1 corresponds to no symptoms and 4 to "a lot" of symptoms. A summary score will be calculated based on items 1-18, Min. value 18, Max. value 72. | through study completion, an average of 1 year and 9 months |
| Difference in QoL from baseline to after chemotherapy course no. 3 | For patients receiving paclitaxel: Difference in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) from baseline compared to after chemotherapy course no. 3. The EORTC-QLQ-C30 is a fully validated and internationally accredited 30-item questionnaire measuring 16 subscales. Items are answered on a scale from 1-4, 1 corresponds to no symptoms and 4 to "a lot" of symptoms. We calculate and report on all 16 subscales. | through study completion, an average of 1 year and 6 months |
| Difference in QoL from baseline to after chemotherapy course no. 6. | For patients receiving paclitaxel: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) from baseline compared to after chemotherapy course no. 6. The EORTC-QLQ-C30 is a fully validated and internationally accredited 30-item questionnaire measuring 16 subscales. Items are answered on a scale from 1-4, 1 corresponds to no symptoms and 4 to "a lot" of symptoms. We calculate and report on all 16 subscales. | through study completion, an average of 1 year and 6 months |
| Difference in QoL from baseline to after chemotherapy course no. 2 | For patients receiving oxaliplatin: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) from baseline compared to after chemotherapy course no. 2. The EORTC-QLQ-C30 is a fully validated and internationally accredited 30-item questionnaire measuring 16 subscales. Items are answered on a scale from 1-4, 1 corresponds to no symptoms and 4 to "a lot" of symptoms. We calculate and report on all 16 subscales. | through study completion, an average of 1 year and 6 months |
| Difference in QoL from baseline to after chemotherapy course no. 4 | For patients receiving oxaliplatin: Difference in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) from baseline compared to after chemotherapy course no. 4. The EORTC-QLQ-C30 is a fully validated and internationally accredited 30-item questionnaire measuring 16 subscales. Items are answered on a scale from 1-4, 1 corresponds to no symptoms and 4 to "a lot" of symptoms. We calculate and report on all 16 subscales. | through study completion, an average of 1 year and 6 months |
| Difference in the Vibrograms after chemotherapy course 1 | For patients receiving paclitaxel: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 6. | through study completion, an average of 1 year and 6 months |
| Difference in the Vibrograms after chemotherapy course 2 | For patients receiving oxaliplatin: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 4. | through study completion, an average of 1 year and 6 months |
| Dose reductions | Number of patients needing a dose reduction in accordance with national Danish treatment guidelines(reasons for discontinuation will be registered). | through study completion, an average of 1 year and 6 months |
| Dose delays | Number of patients needing a dose delay in accordance with national Danish treatment guidelines(reasons for discontinuation will be registered). | through study completion, an average of 1 year and 6 months |
| Not completing planned courses of chemotherapy | Number of patients not completing their planned courses of chemotherapy (reasons for discontinuation will be registered). | through study completion, an average of 1 year and 6 months |
| Side Effects (Patient Reported) | Patients will be asked to report their side effects using an digitalized version of the Patient Reported Outcome of Common Terminology Criteria for Adverse Events. (PRO-CTCAE). The PRO-CTCAE items evaluate different symptom attributes; frequency, severity, interference, amount, presence/absence, utilizing "yes" and "no" categories for presence/absence and a 1-5 grading scale for frequency, severity, interference, amount. 1 corresponds to best symptoms manifestation, 5 to worst symptom manifestation. | through study completion, an average of 1 year and 6 months |
| Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 3 months (PAC) | For patients receiving paclitaxel: Difference in the Vibrograms at day 3-5 from baseline compared to CIPN18 total score at follow-up 3 months after treatment | through study completion, an average of 9 months |
| Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 3 months (OX) | For patients receiving oxaliplatin: Difference in the Vibrograms at day 3-5 from baseline compared to CIPN18 total score at follow-up 3 months after treatment | through study completion, an average of 9 months |
| Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 12 months (PAC) | For patients receiving paclitaxel: Difference in the Vibrograms at day 3-5 from baseline compared to CIPN18 total score at follow-up 12 months after treatment | through study completion, an average of 1 year and 6 months |
| Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 12 months (OX) | For patients receiving oxaliplatin: Difference in the Vibrograms at day 3-5 from baseline compared to CIPN18 total score at follow-up 12 months after treatment | through study completion, an average of 1 year and 6 months |