Exploratory non-interventional, open-label, prospective, longitudinal 12-week parallel group study to assess the efficacy and safety of a balanced (10mg:10mg) THC/CBD cannabinoid extract in adult patients* suffering from otherwise refractory chemotherapy-induced neuropathic pain (CINP). (OCEAN)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Exploratory, open-label, prospective, longitudinal 12-week parallel group study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DELTA(9)-TETRAHYDROCANNABINOLIC ACID

  CANNABIDIOL
• Medical condition to be studied:
  Neuralgia
• Additional medical condition(s):
  Chemotherapy-induced neuropathic pain

Population studied

• Short description of the study population:
  Adult patients with refractory chemotherapy-induced neuropathic pain received cannabinoid extract as add-on treatment with standard of care identified from the German Pain e-Registry.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with refractory chemotherapy-induced neuropathic pain
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  The aim of OCEAN is to gain knowledge about the specific safety, tolerability and efficacy of the cannabinoid cultivar Jack Haze and its application in the form of a full-spectrum extract balanced in terms of THC and CBD content (10:10) in adult patients with otherwise therapy-difficult chemotherapy-induced neuropathic pain (CINP) under everyday conditions (so-called real-world evidence).
• Outcomes:
  Primary endpoint is the proportion of patients in both cohorts who shall report at end of week 12 vs. baseline either an absolute improvement ? the minimal clinical important difference (MCID) or a relative improvement ? 30% for a) average 24-hr. pain intensity, b) pain-related disabilities in daily life, c) pain-related sleep disturbances, and d) neuropathic pain phenomenology. Efficacy: absolute and relative changes at end of week 12 vs. baseline for all single items of the primary endpoint. Safety/tolerability: number and spectrum of adverse drug reactions (ADRs), proportion of patients affected by ADRs.
• Data analysis plan:
  Descriptive and inferential statistical analyses will be performed as reported. For continuous variables, descriptive statistics will be summarized by the number of patients (n), the mean, standard deviation (SD), 95% confidence intervals (95%-CI) of the mean, median, and range (minimum – maximum) values. For categorical and ordinal variables data will be summarized by frequency number (n), percentage (%) and (where appropriate) adjusted percentage (a%) of participants in each category, incl. 95% confidence intervals. For between groups comparisons of 2x2 contingency tables with a dichotomous/binomial trait McNemar´s test (with the Edwards correction) will be applied, and Pearson's chi-squared tests will be used for categorial variables with multinomial expressions. Between groups comparisons of continuous variables will be applied dependent on the data distribution: for normally distributed data paired samples t-tests and for non-normal distributions Wilcoxon´s signed rank test.