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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
54
Patients receive cannabidiol before and after treatment with chemotherapy
Department of Clinical Oncology and Palliative Care
Roskilde, Denmark
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.
Time frame: 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.
Time frame: up to 5 days
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
Time frame: through study completion, an average of 1 year and 6 months
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
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: through study completion, an average of 1 year and 6 months