CBD and other cannabinoids to be used for TIPN study

Why is treating taxane-induced peripheral neuropathy (TIPN) so crucial? How likely is this health concern to affect you?

According to the National Breast Cancer Foundation, 1 in 8 women will receive a breast cancer diagnosis at some point in her lifetime. While it might not be you, it could be someone you know who suffers from TIPN. With this in mind, if there’s a cannabinoid that can help ease the treatment and healing processes, the world needs to know.

People have been using cannabinoids for thousands of years. Even with this being the case, there isn’t enough research to definitively say what cannabis can and can’t treat. However, the Tilray clinical trial is set to pave the way for other cannabis trials by showing how cannabis affects breast cancer treatments.

What Makes Cannabis Research with Human Subjects so Fascinating?

Besides the potential to reveal another one of the treatment possibilities of cannabis, using human subjects has a more significant impact on society. While researchers can more easily conduct animal trials, the level of credibility a trial with human subjects receives is higher.

As you can probably imagine, getting approval for cannabis research without human test subjects isn’t easy. So the fact that this human subject research will happen is incredible.

Conducting cannabis clinical trials is labor-intensive because it involves interacting with several federal agencies. Marijuana medical research isn’t something that’s happening without jumping through bureaucratic hoops. These are federal agencies involved in the process:

  • National Institute on Drug Abuse (NIDA) –– The NIDA drug supply program is where scientific studies get their research-grade marijuana. This program operates under the guidance of the Single Convention on Narcotic Drugs to ensure the growers meet specific governmental marijuana cultivation obligations.
  • Food and Drug Administration (FDA) –– The FDA demands researchers submit an IND application before they allow the researchers to conduct clinical research on cannabis. This application gives the researchers a path to adhere to, including regular interactions with the FDA to support efficient drug development. The application also protects the patients enrolled in these trials. In conjunction with the FDA, the Guidance for Industry Botanical Drug Development gives the sponsors with guidance regarding submitting investigational INDs for botanical drug products 
  • Drug Enforcement Administration (DEA) –– The DEA requires special licensure and registration for investigators and sites where the study will take place.

  • What is Taxane-Induced Peripheral Neuropathy (TIPN)?

    The taxane-derived agents in the chemotherapy drugs, paclitaxel and docetaxel most commonly, cause taxane antineoplastic activity in cancer cells. This leads to mitotic arrest and apoptosis in these harmful cells.

    However, peripheral neurotoxicity is the primary non-hematological adverse effect of taxane. This typically manifests as painful neuropathy during the treatments, but at times, the resulting TIPN is irreversible.

    As a form of peripheral neuropathy, damaged nerves responsible for carrying messages to and from the brain and spinal cord cause this issue. With this in mind, the goal of treatment is to manage the condition and relieve symptoms.

    While neuropathy treatment is possible, it’s somewhat limited. Doctors typically prescribe pain relievers, anti-seizure medications, topical treatments, and antidepressants to help, but these medications come with a host of adverse side effects.

    Some patients find specific therapies and procedures help. These usually include transcutaneous electrical nerve stimulation (TENS), plasma exchange and intravenous immune globulin, physical therapy, and surgery.

    Medical Benefits of Cannabis Studies

    While we’re lacking research on using CBD for neuropathy, some studies show cancer growth slowed with cannabidiol application. According to the National Cancer Institute, some cancers could slow in growth with cannabis and cannabinoid introduction–and this includes breast cancer.

    Even though cannabis will have to go through more research to determine whether it’s helpful for peripheral neuropathy and cancer, other research highlights there’s a good chance it’s applicable. The current research suggests some of the chemo side effects, including anxiety and nausea, could lessen in severity.

    With more cannabis studies, we stand to learn more about how we can successfully treat specific ailments with cannabidiol. There’s still much to uncover in this field, and the demand for more research is there. At this point, it’s all about going through the processes necessary to begin conducting the investigation.

    Many experts think that with this additional research, we’ll learn how much CBD can help breast cancer patients. However, even if the treatment is successful, it’s best to adhere to a plan from an oncologist. So speaking with your doctor before trying CBD is crucial.

    Overview of The Study

    The study, The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy, is still in the recruitment status as of September 20, 2019. The sponsor, the New York State Psychiatric Institute, and investigator, Diana Martinez of the New York State Psychiatric Institute, are responsible for the safety and scientific validity of this study.

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    Alt: Table showing condition chemotherapy-induced peripheral neuropathy to be treated with cannabinoids

    The problem this study aims to resolve is how TIPN impacts many women going through breast cancer treatment. This side effect of treatment hurts some of these women to the point that they have to shorten their course of treatment, meaning these women don’t experience the full benefits of their chemotherapy.

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    Alt: Table showing use of varied strength cannabinoids across groups for study

    Rodent studies highlight that cannabinoids might provide significant improvement for hyperalgesia and allodynia paclitaxel induces. However, the primary goal of this study is to show how THC and CBD affect TIPN.

    During this study, the investigators will study how effective cannabinoids are at treating TIPN. The test subjects are volunteers with a breast cancer diagnosis and chemotherapy-induced peripheral neuropathy following the administration of docetaxel or paclitaxel.

    The researchers will administer cannabinoids of various strengths in capsules. They will measure the pain and functional impairment to determine the efficacy. These scales will include the following:

    1. Brief Pain Inventory-Short Form (BPI) for pain severity (change over 8 weeks)
    2. BPI pain interference subscale for functional impairment (change over 8 weeks)

    The subject analysis will also involve secondary measures of perception.

    This is an interventional study that will involve 100 participants. The subjects will be randomized in this triple-blind study (Participant, Investigator, and Outcomes Assessor).

    Can Cannabinoids Treat Peripheral Neuropathy?

    Is it possible? Yes. Do we have enough data to definitively say CBD can treat peripheral neuropathy? Not yet, but that’s why these researchers are conducting this study.

    The incredible aspect to note is that government agencies are now allowing human studies to demonstrate the efficacy of cannabis for some ailments. While we’re still not sure which ailments CBD can treat, conducting more studies like this one has the potential to reveal the real power of cannabis.