Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy
- Registration Number
- NCT04582591
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 54
- ≥ 18 years of age.
- A diagnosis of cancer.
- Fulfill criteria for starting chemotherapy.
- Scheduled to undergo at least 6 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy.
- If not postmenopausal (defined as no menses for 12 months without an alternative medical cause), women will have use effective anti-contraception (using definitions in the CTFG*-Recommendations related to contraception and pregnancy testing in clinical trials) and submit to a monthly pregnancy test (blood test).
- Unable to complete PRO-measurements.
- Previously received taxanes or platinum-based chemotherapy.
- If using any antiepileptic or antidepressant medicine (ATC: N03A or N06A). Treatment must be stable (no changes in dosing in last 30 days) prior to inclusion. However, any treatment with Clobazam (N05BA09) is not allowed due to major interaction with cannabidiol.
- Use of cannabinoids. If in use, treatment must be stopped 4 days prior to inclusion.
- Hypersensitivity reactions towards Ascorbylpalmitat or Triglycerides (medium-chain)
- Baseline transaminase level must not be above 3 times the Upper Limit of Normal (ULN) at study beginning.
- Women who are breastfeeding.
- Concomitant treatment with strong inducers of CYP3A4 and/or strong inducers of CYP2C19.
CTFG: The Heads of Medicines Agencies commissioned Clinical Trials Facilitation Group under the European Union's clinical trials directive 2001/20.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cannabidiol Cannabidiol 100 MG/ML Patients will receive cannabidiol in conjunction with their standard chemotherapy treatment
- Primary Outcome Measures
Name Time Method Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy. up to 5 days 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.Difference in Vibrograms from baseline and during 1. course chemotherapy. up to 5 days Difference in the Vibrograms from baseline compared to 3-5 days after initiation of chemotherapy course no. 1.
- Secondary Outcome Measures
Name Time Method 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). through study completion, an average of 1 year and 6 months For patients receiving paclitaxel-based chemotherapy
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) through study completion, an average of 1 year and 6 months For patients receiving oxaliplatin-based chemotherapy
Difference in CIPN from baseline to after chemotherapy course no. 3 through study completion, an average of 1 year and 6 months 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.Difference in CIPN from baseline to 1. follow-up (OX) through study completion, an average of 1 year and 9 months 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.Difference in CIPN from baseline to after chemotherapy course no. 6 through study completion, an average of 1 year and 6 months 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.Difference in CIPN from baseline to 1. follow-up (PAC) through study completion, an average of 1 year and 9 months 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.Difference in the Vibrograms after chemotherapy course 1 through study completion, an average of 1 year and 6 months For patients receiving paclitaxel: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 6.
Dose reductions through study completion, an average of 1 year and 6 months Number of patients needing a dose reduction in accordance with national Danish treatment guidelines(reasons for discontinuation will be registered).
Dose delays through study completion, an average of 1 year and 6 months Number of patients needing a dose delay in accordance with national Danish treatment guidelines(reasons for discontinuation will be registered).
Difference in CIPN from baseline to after chemotherapy course no. 2 through study completion, an average of 1 year and 6 months 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.Difference in CIPN from baseline to after chemotherapy course no. 4 through study completion, an average of 1 year and 6 months 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.Difference in QoL from baseline to after chemotherapy course no. 3 through study completion, an average of 1 year and 6 months 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.Difference in QoL from baseline to after chemotherapy course no. 6. through study completion, an average of 1 year and 6 months 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.Difference in QoL from baseline to after chemotherapy course no. 4 through study completion, an average of 1 year and 6 months 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.Difference in QoL from baseline to after chemotherapy course no. 2 through study completion, an average of 1 year and 6 months 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.Difference in the Vibrograms after chemotherapy course 2 through study completion, an average of 1 year and 6 months For patients receiving oxaliplatin: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 4.
Not completing planned courses of chemotherapy through study completion, an average of 1 year and 6 months Number of patients not completing their planned courses of chemotherapy (reasons for discontinuation will be registered).
Trial Locations
- Locations (1)
Department of Clinical Oncology and Palliative Care
🇩🇰Roskilde, Denmark