Ensayos clínicos

Registration - Inclusion Criteria:

• Age ≥ 18 years.
• English speaking.
• Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy.
• At least 4 out of 10 severity of neuropathy pain and/or tingling per appendix IV.
• Stable for at least 7 days prior to registration [SJB1] [LCLM2] [GAM3] on medications for neuropathy, if any are being used.
• ECOG Performance Status (PS) 0, 1 or 2.
• Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
  • NOTE: If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Able to provide written informed consent.
• Ability to complete questionnaire(s) by themselves or with assistance.
• No evidence of residual cancer.
• Required Initial Laboratory Values: Following completion of chemotherapy, patients must have had a CBC and serum chemistries, including the following:
• • • Platelet count > 100,000/mm^3;
    • Absolute neutrophil count (ANC) ≥ 1,000/mm^3;
    • Hemoglobin > 11 g/dL;
    • Serum transaminase [ALT or AST] ≤ 1.2 x upper limit of normal (ULN);
    • Alkaline phosphatase ≤ 1.2 x ULN;
    • Serum creatinine ≤ 1.2 x ULN.

Registration - Exclusion Criteria:

• Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant persons;
  • Nursing persons;
  • Persons of childbearing potential who are unwilling to employ adequate contraception.
• Any medical condition that would prohibit use of a topical cream (skin infection or open wound in the area of the neuropathy).
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
• Pre-existing neuropathy prior to chemotherapy that would confuse the issue of CIPN.
• Currently on chemotherapy or received chemotherapy treatment within the prior 3 months.
• Use of other cannabis products within 30 days prior to registration.
• History of allergy to cannabis products.

Crossover Re-Registration – Inclusion Criteria:

• Treatment cannot begin prior to registering to the crossover phase and will ideally begin ≤ 7 days after registration for the crossover phase.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.