Cannabinoids for Taxane Induced Peripheral Neuropathy
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 08/31/2019 |
| Pirmasis pateikimas: | 12/17/2018 |
| Numatytas registravimas pateiktas: | 12/17/2018 |
| Pirmas paskelbtas: | 12/19/2018 |
| Paskutinis atnaujinimas pateiktas: | 09/17/2019 |
| Paskutinis atnaujinimas paskelbtas: | 09/19/2019 |
| Faktinė studijų pradžios data: | 08/31/2019 |
| Numatoma pirminio užbaigimo data: | 01/31/2021 |
| Numatoma studijų užbaigimo data: | 01/31/2022 |
Būklė ar liga
Intervencija / gydymas
Drug: Cannabinoids
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: Cannabinoids of varied strength Strengths of cannabinoids will vary across groups | |
| Active Comparator: Cannabinoids of various strengths Strengths of cannabinoids will vary across groups |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 21 Years Į 21 Years |
| Tinkamos studijoms lytys | Female |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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. |
Rezultatas
Pirminės rezultatų priemonės
1. Brief Pain Inventory-Short Form (BPI) [change over 8 weeks]
Antrinės rezultatų priemonės
1. Functional Assessment of Cancer Therapy Taxane [change over 8 weeks]
2. Total Neuropathy Score (TNSc) a scale of sensory, motor and autonomic symptoms [change over 8 weeks]
