Clinical trial NCT04582591: Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: CIPN
Cannabinoid
Cannabidiol
CBD
Neurotoxic Chemotherapy
paclitaxel
oxaliplatin
Peripheral Neuropathy
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2020-10-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy.
timeFrame: up to 5 days
measure: Difference in Vibrograms from baseline and during 1. course chemotherapy.
timeFrame: up to 5 days
Secondary outcomes:
measure: 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).
timeFrame: through study completion, an average of 1 year and 6 months
measure: 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)
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in CIPN from baseline to after chemotherapy course no. 3
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in CIPN from baseline to after chemotherapy course no. 6
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in CIPN from baseline to 1. follow-up (PAC)
timeFrame: through study completion, an average of 1 year and 9 months
measure: Difference in CIPN from baseline to after chemotherapy course no. 2
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in CIPN from baseline to after chemotherapy course no. 4
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in CIPN from baseline to 1. follow-up (OX)
timeFrame: through study completion, an average of 1 year and 9 months
measure: Difference in QoL from baseline to after chemotherapy course no. 3
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in QoL from baseline to after chemotherapy course no. 6.
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in QoL from baseline to after chemotherapy course no. 2
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in QoL from baseline to after chemotherapy course no. 4
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in the Vibrograms after chemotherapy course 1
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in the Vibrograms after chemotherapy course 2
timeFrame: through study completion, an average of 1 year and 6 months
measure: Dose reductions
timeFrame: through study completion, an average of 1 year and 6 months
measure: Dose delays
timeFrame: through study completion, an average of 1 year and 6 months
measure: Not completing planned courses of chemotherapy
timeFrame: through study completion, an average of 1 year and 6 months
Other outcomes:
measure: Side Effects (Clinician Scored)
timeFrame: through study completion, an average of 1 year and 6 months
measure: Side Effects (Patient Reported)
timeFrame: through study completion, an average of 1 year and 6 months
measure: Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 3 months (PAC)
timeFrame: through study completion, an average of 9 months
measure: Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 3 months (OX)
timeFrame: through study completion, an average of 9 months
measure: Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 12 months (PAC)
timeFrame: through study completion, an average of 1 year and 6 months
measure: Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 12 months (OX)
timeFrame: through study completion, an average of 1 year and 6 months
Locations:
city: Roskilde
country: Denmark
facility: Department of Clinical Oncology and Palliative Care
Study officials:
affiliation: Zealand University Hospital / University of Copenhagen
name: Jørn Herrstedt, DMSc
role: STUDY_CHAIR
affiliation: Zealand University Hospital / University of Copenhagen
name: Sebastian W Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References: