1- Cancer Patients During Chemotherapy Treatment Clinical Trial
Official title:
Cannabis-related Cognitive Impairment: Prospective Evaluation of Possible Influences in Cancer Patients During Active Oncology Treatment
| Verified date | May 2017 |
| Source | Rambam Health Care Campus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Cannabis sativa is one of the most ancient psychotropic drugs known to humanity. Although
most Western countries have outlawed the use of cannabis according to the UN Convention of
Psychotropic Substances, an increasing number of states in the USA, Canada and several
European countries allow the medicinal use of cannabis subject to a doctor's recommendation.
In oncology, the beneficial effects of treatment with the plant or treatment with medicine
produced from its components are related to symptoms of the disease: pain, nausea and
vomiting, loss of appetite and weight loss. There is only partial clinical evidence of the
efficacy of cannabis for these indications. In Israel, according to Ministry of Health
regulations, permission to use medicinal cannabis for oncology patients can be given for two
indications: to relieve disease-related symptoms in advanced disease or during chemotherapy
treatment to reduce side effects. The indications are very wide and allow a great deal of
freedom for the physician's decisions, but also cause high demands for cannabis from
patients.
The cannabis plant and the synthetic drugs based on the plant are considered to be medically
safe. Most of the adverse effects are related to the fact that the plant and the drugs are
psychoactive. Among the effects named were dizziness, euphoria, difficulty concentrating,
disturbances in thinking, memory loss, and loss of coordination.
Recently, we published the results of a prospective, observational study evaluating the
medical necessity for medicinal cannabis treatment in cancer patients on supportive or
palliative care. No significant side effects, except for memory lessening in patients with
prolonged cannabis use (p=0.002), were noted.
Chemotherapy-related cognitive impairment (CRCI) is a phenomenon of cognitive decline that
patients may experience during or after chemotherapy. Memory loss and lack of concentration
and attention are the most frequent symptoms encountered. Evidence suggests that CRCI is of
significant concern to patients and has become a major quality-of-life issue for survivors,
with estimates of its frequency ranging from 14-85% of patients. The influence of cannabis
use on cognitive functions of oncology patients has never been tested. Theoretically, the
combination of chemotherapy and cannabis can cause severe reduction in cognitive functions
in additive or synergistic ways. However, this hypothesis, too, has never been tested,
although the number of patients using cannabis during chemotherapy treatments in Israel and
in other Western countries is growing.
Goals of current research: The main goal of the study is to evaluate prospectively the level
of reduction in cognitive function of cancer patients who are on active oncology treatments
and use cannabis, comparing to a group of patients without cannabis treatment. The second
goal is to identify high-risk groups for cognitive impairment due to cannabis use.
Patients and Methods: The study will be comprised of a cannabis user group that will include
patients who will come for guidance sessions before being issued with a cannabis license and
a control group of patients on active oncology treatments, meeting the same inclusion and
exclusion criteria (except for cannabis use), and willing to complete the same pack of
questionnaires and cognitive tests at the same three time points. All patients will sign an
informed consent form. The study includes questionnaires on quality of life (EORTC-Q30),
anxiety, depression (HADS) and fatigue (BFI), and cognitive tests (MoCA, DSST, Digital
Finger Tapping) administered by the nurses who give guidance on cannabis according to the
patient's language (Hebrew, Russian or Arabic). The nurses will have a short guidance course
on "how to do cognitive tests" and a monthly meeting with a neuropsychologist to test the
quality of the cognitive tests. The questionnaires and cognitive tests will be done on the
day of entering the study (T0) and after 3 (T3) and 6 months (T6). The patients will be
asked not to use cannabis in the 12 hours before the interviews after 3 and 6 months.
Sample size: The sample size was built to show a difference of 1.1 points in the MoCA test
(half the SD for the normal population) between two groups after three months of cannabis
use. The number of patients needed with a power of 80%, β≤0.05 and SD=3.1 (the SD for mild
cognitive impairment in the MoCA test) is calculated at 42 patients in each group (total 84
patients). Due to an expected drop-out of 20%, the number of patients to be included in the
study is 101.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | April 26, 2017 |
| Est. primary completion date | April 26, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 120 Years |
| Eligibility |
Inclusion Criteria: 1. Age >18 years 2. Histological or cytological documentation of malignancy 3. Chemotherapy treatment 4. Life expectancy of at least 6 months 5. Able to sign informed consent. Exclusion Criteria: 1. Brain tumors or CNS metastasis 2. Past cannabis use, 3. Known cognitive diseases such as Alzheimer's disease or other dementias |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Oncology Institute, Rambam Health Care Campus | Haifa |
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cannabis effect on cognitive function during chemotherapy | Level of cognitive function as measured by the cognitive tests MoCA and DSST questionnaires and Digital Finger Tapping | 6 months for each patient |