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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04582591
Recruitment Status : Active, not recruiting
First Posted : October 9, 2020
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Drug: Cannabidiol 100 MG/ML Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Trial of Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy
Actual Study Start Date : March 3, 2021
Actual Primary Completion Date : January 5, 2022
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

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 Name: CBD




Primary Outcome Measures :
  1. 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.


  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.


  8. 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.


  9. 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.


  10. 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.


  11. 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.


  12. 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.


  13. 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.

  14. 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.

  15. 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).

  16. 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).

  17. 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).


Other Outcome Measures:
  1. 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.


  2. 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.


  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582591


Locations
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Denmark
Department of Clinical Oncology and Palliative Care
Roskilde, Denmark, 4000
Sponsors and Collaborators
Zealand University Hospital
University of Copenhagen
Investigators
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Study Chair: Jørn Herrstedt, DMSc Zealand University Hospital / University of Copenhagen
Principal Investigator: Sebastian W Nielsen, MD Zealand University Hospital / University of Copenhagen
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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT04582591    
Other Study ID Numbers: REG-114-2020
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
CIPN
Cannabinoid
Cannabidiol
CBD
Neurotoxic Chemotherapy
paclitaxel
oxaliplatin
Peripheral Neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cannabidiol
Anticonvulsants