Chemotherapy-induced Peripheral Neuropathy
Conditions
Brief summary
Taxane-induced peripheral neuropathy (TIPN) affects a significant number of women undergoing breast cancer treatment. Some patients may need to shorten their course of treatment, and do not receive the full benefit of chemotherapy as a result. Rodent studies have shown that the cannabinoids may significantly improve hyperalgesia and allodynia induced by paclitaxel. The goal of this study is to investigate the cannabinoids THC and CBD for TIPN.
Detailed description
The investigators' goal is to study the efficacy of cannabinoids as a potential treatment for TIPN. Volunteers with a diagnosis of breast cancer and chemotherapy-induced peripheral neuropathy, secondary to treatment with paclitaxel or docetaxel, will be enrolled. This study involves the administration of cannabinoids in different strength capsules. The primary outcome measures include measures of pain and functional impairment (non-painful symptoms). The scales will include: 1) Brief Pain Inventory-Short Form (BPI) for pain severity ; and 2) BPI pain interference subscale for functional impairment. The study outcomes will also include secondary measures of perception, which will be performed in the laboratory.
Interventions
DRUGCannabinoids
Cannabinoids with THC and CBD versus placebo cannabinoids
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 1\) Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel. * 2\) Participants must have an ECOG score of 2 or better. Participants must have a score of 2 or 3 score for sensory neuropathy, as assessed by the Common Toxicity Criteria Adverse Events (CTCAE). * 3\) Able to give informed consent and comply with all study procedures.
Exclusion criteria
* 1\) Diagnosis of a major medical, neurological, or psychiatric disorder that would preclude study participation. * 2\) Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant. * 3\) Subjects taking warfarin. * 4\) Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or neurodegenerative disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory-Short Form (BPI) | value at the later time (8 weeks) point minus the value at the earlier time point (baseline) | This is a standard questionnaire to measure pain.It is used to evaluate pain through a number of different scales. Patients fill out 11 different questions that ask about pain intensity (present and least, most, and average for the past 24 hours) and the effect of the pain on the ability to function during various activities of daily living. Higher number is worse. range is 0 to 10 |
Other
| Measure | Time frame |
|---|---|
| Functional Assessment of Cancer Therapy Taxane | Baseline and weekly until end of study. |
Countries
United States
Participant flow
Pre-assignment details
Participants were assigned based on history of cannabis use.
Participants by arm
| Arm | Count |
|---|---|
| Cannabinoids (THC and CBD) Cannabinoids THC and CBD titrated | 6 |
| Placebo Cannabinoids placebo cannabinoids for comparison | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Cannabinoids (THC and CBD) | Total | Placebo Cannabinoids |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 12 Participants | 6 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 8 | 54 years STANDARD_DEVIATION 8 | 54 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 9 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 2 / 6 | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Brief Pain Inventory-Short Form (BPI)
This is a standard questionnaire to measure pain.It is used to evaluate pain through a number of different scales. Patients fill out 11 different questions that ask about pain intensity (present and least, most, and average for the past 24 hours) and the effect of the pain on the ability to function during various activities of daily living. Higher number is worse. range is 0 to 10
Time frame: value at the later time (8 weeks) point minus the value at the earlier time point (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cannabinoids (THC Ans CBD) | Brief Pain Inventory-Short Form (BPI) | 4.8 units on a scale | Standard Deviation 1.5 |
| Placebo Cannabinoids | Brief Pain Inventory-Short Form (BPI) | 5.8 units on a scale | Standard Deviation 1.5 |
Other Pre-specified
Functional Assessment of Cancer Therapy Taxane
Time frame: Baseline and weekly until end of study.
Post Hoc
Total Neuropathy Score (TNSc) a Scale of Sensory, Motor and Autonomic Symptom
Time frame: Baseline and weekly until end of study