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Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy (CINCAN-2)

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cannabidiol 100 MG/ML
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring CIPN, Cannabinoid, Cannabidiol, CBD, Neurotoxic Chemotherapy, paclitaxel, oxaliplatin, Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 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).

Exclusion Criteria:

  • 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.

Sites / Locations

  • Department of Clinical Oncology and Palliative Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cannabidiol

Arm Description

Patients will receive cannabidiol in conjunction with their standard chemotherapy treatment

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Dose reductions
Number of patients needing a dose reduction in accordance with national Danish treatment guidelines(reasons for discontinuation will be registered).
Dose delays
Number of patients needing a dose delay in accordance with national Danish treatment guidelines(reasons for discontinuation will be registered).
Not completing planned courses of chemotherapy
Number of patients not completing their planned courses of chemotherapy (reasons for discontinuation will be registered).

Full Information

First Posted
September 29, 2020
Last Updated
February 7, 2022
Sponsor
Zealand University Hospital
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04582591
Brief Title
Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy
Acronym
CINCAN-2
Official Title
A Phase II Trial of Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy
Keywords
CIPN, Cannabinoid, Cannabidiol, CBD, Neurotoxic Chemotherapy, paclitaxel, oxaliplatin, Peripheral Neuropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol
Arm Type
Experimental
Arm Description
Patients will receive cannabidiol in conjunction with their standard chemotherapy treatment
Intervention Type
Drug
Intervention Name(s)
Cannabidiol 100 MG/ML
Other Intervention Name(s)
CBD
Intervention Description
Patients receive cannabidiol before and after treatment with chemotherapy
Primary Outcome Measure Information:
Title
Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy.
Description
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
Title
Difference in Vibrograms from baseline and during 1. course chemotherapy.
Description
Difference in the Vibrograms from baseline compared to 3-5 days after initiation of chemotherapy course no. 1.
Time Frame
up to 5 days
Secondary Outcome Measure Information:
Title
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).
Description
For patients receiving paclitaxel-based chemotherapy
Time Frame
through study completion, an average of 1 year and 6 months
Title
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)
Description
For patients receiving oxaliplatin-based chemotherapy
Time Frame
through study completion, an average of 1 year and 6 months
Title
Difference in CIPN from baseline to after chemotherapy course no. 3
Description
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.
Time Frame
through study completion, an average of 1 year and 6 months
Title
Difference in CIPN from baseline to after chemotherapy course no. 6
Description
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
Title
Difference in CIPN from baseline to 1. follow-up (PAC)
Description
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
Title
Difference in CIPN from baseline to after chemotherapy course no. 2
Description
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
Title
Difference in CIPN from baseline to after chemotherapy course no. 4
Description
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
Title
Difference in CIPN from baseline to 1. follow-up (OX)
Description
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
Title
Difference in QoL from baseline to after chemotherapy course no. 3
Description
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
Title
Difference in QoL from baseline to after chemotherapy course no. 6.
Description
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
Title
Difference in QoL from baseline to after chemotherapy course no. 2
Description
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
Title
Difference in QoL from baseline to after chemotherapy course no. 4
Description
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
Title
Difference in the Vibrograms after chemotherapy course 1
Description
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
Title
Difference in the Vibrograms after chemotherapy course 2
Description
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
Title
Dose reductions
Description
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
Title
Dose delays
Description
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
Title
Not completing planned courses of chemotherapy
Description
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
Other Pre-specified Outcome Measures:
Title
Side Effects (Clinician Scored)
Description
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.
Time Frame
through study completion, an average of 1 year and 6 months
Title
Side Effects (Patient Reported)
Description
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.
Time Frame
through study completion, an average of 1 year and 6 months
Title
Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 3 months (PAC)
Description
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
Time Frame
through study completion, an average of 9 months
Title
Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 3 months (OX)
Description
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
Time Frame
through study completion, an average of 9 months
Title
Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 12 months (PAC)
Description
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
Time Frame
through study completion, an average of 1 year and 6 months
Title
Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 12 months (OX)
Description
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
Time Frame
through study completion, an average of 1 year and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørn Herrstedt, DMSc
Organizational Affiliation
Zealand University Hospital / University of Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sebastian W Nielsen, MD
Organizational Affiliation
Zealand University Hospital / University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Oncology and Palliative Care
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy

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