Not provided
Not provided
Not provided
Not provided
Not provided
Funding being sought
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabinoids (THC and CBD) | Experimental | THC and CBD |
|
| Placebo Cannabinoids | Placebo Comparator | placebo cannabinoids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabinoids | Drug | Cannabinoids with THC and CBD versus placebo cannabinoids |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | value at the later time (8 weeks) point minus the value at the earlier time point (baseline) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy Taxane | Baseline and weekly until end of study. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1051 Riverside Drive | New York | New York | 10032 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were assigned based on history of cannabis use.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cannabinoids (THC and CBD) | Cannabinoids with THC and CBD, titrated to a maximum of 15 mg THC, 300 mg CBD |
| FG001 | Placebo Cannabinoids | Placebo cannabinoids for comparison |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cannabinoids (THC and CBD) | Cannabinoids THC and CBD titrated |
| BG001 | Placebo Cannabinoids | placebo cannabinoids for comparison |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | value at the later time (8 weeks) point minus the value at the earlier time point (baseline) |
|
Adverse events were collected over 8 weeks.
No participants were expected to ne at risk for all-cause mortality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cannabinoids (THC and CBD) | Strengths of cannabinoids will vary across groups Cannabinoids: Cannabinoids with different concentrations of THC and CBD |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | SNOMED CT | Systematic Assessment |
Please note: this was a pilot study that was not funded for a full study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Martinez | CUIMC | 646-774-6160 | dm437@cumc.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 23, 2021 | Aug 2, 2022 | Prot_SAP_ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| ID | Term |
|---|---|
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Placebo with no THC to CBD
|
|
| Other Pre-specified | Functional Assessment of Cancer Therapy Taxane | Not Posted | Oct 2028 | Baseline and weekly until end of study. | Participants |
| Post-Hoc | Total Neuropathy Score (TNSc) a Scale of Sensory, Motor and Autonomic Symptom | Not Posted | Oct 2030 | Baseline and weekly until end of study | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Placebo Cannabinoids | Strengths of cannabinoids will vary across groups Cannabinoids: Cannabinoids with different concentrations of THC and CBD | 0 | 6 | 0 | 6 | 2 | 6 |
Not provided
Not provided
Not provided