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

February 7, 2022 updated by: Zealand University Hospital

A Phase II Trial of Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Department of Clinical Oncology and Palliative Care

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cannabidiol
Patients will receive cannabidiol in conjunction with their standard chemotherapy treatment
Drug: Cannabidiol 100 MG/ML
Patients receive cannabidiol before and after treatment with chemotherapy
Other Names:
  • CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy.
Time Frame: 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.
up to 5 days
Difference in Vibrograms from baseline and during 1. course chemotherapy.
Time Frame: up to 5 days
Difference in the Vibrograms from baseline compared to 3-5 days after initiation of chemotherapy course no. 1.
up to 5 days

Secondary Outcome Measures

Outcome Measure
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).
Time Frame: through study completion, an average of 1 year and 6 months
For patients receiving paclitaxel-based chemotherapy
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)
Time Frame: through study completion, an average of 1 year and 6 months
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
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to after chemotherapy course no. 6
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to 1. follow-up (PAC)
Time Frame: 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.
through study completion, an average of 1 year and 9 months
Difference in CIPN from baseline to after chemotherapy course no. 2
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to after chemotherapy course no. 4
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in CIPN from baseline to 1. follow-up (OX)
Time Frame: 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.
through study completion, an average of 1 year and 9 months
Difference in QoL from baseline to after chemotherapy course no. 3
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in QoL from baseline to after chemotherapy course no. 6.
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in QoL from baseline to after chemotherapy course no. 2
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in QoL from baseline to after chemotherapy course no. 4
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in the Vibrograms after chemotherapy course 1
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in the Vibrograms after chemotherapy course 2
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Dose reductions
Time Frame: 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).
through study completion, an average of 1 year and 6 months
Dose delays
Time Frame: 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).
through study completion, an average of 1 year and 6 months
Not completing planned courses of chemotherapy
Time Frame: 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).
through study completion, an average of 1 year and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side Effects (Clinician Scored)
Time Frame: through study completion, an average of 1 year and 6 months

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
Side Effects (Patient Reported)
Time Frame: through study completion, an average of 1 year and 6 months

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)
Time Frame: through study completion, an average of 9 months
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)
Time Frame: through study completion, an average of 9 months
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)
Time Frame: through study completion, an average of 1 year and 6 months
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)
Time Frame: through study completion, an average of 1 year and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

University of Copenhagen

Investigators

  • Study Chair: Jørn Herrstedt, DMSc, Zealand University Hospital / University of Copenhagen
  • Principal Investigator: Sebastian W Nielsen, MD, Zealand University Hospital / University of Copenhagen

Study record dates

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 Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

January 5, 2022

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-114-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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