A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
批准号:
10512235
负责人:
Richard T Lee
金额:
$45.25万
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-09-23 至 2024-08-31
关键词:
AddressAdultAnalgesicsCancer PatientCancer SurvivorCannabidiolCannabisChemotherapy-induced peripheral neuropathyChronicClinicalClinical ResearchClinical TrialsColon CarcinomaCommon Terminology Criteria for Adverse EventsCommunitiesDataDetectionGynecologic Oncology GroupHempKnowledgeLegalLifeLimb structureMalignant NeoplasmsMeasuresMedical MarijuanaModalityNervous System PhysiologyNeurologic SymptomsNeuropathyNumbnessOutcomePainPatientsPilot ProjectsPlacebosQuality of lifeRandomizedRandomized Clinical TrialsRandomized Controlled TrialsResearchSensorySideSymptomsSyndromeTestingTetrahydrocannabinolTimeTreatment Side EffectsVisualWorkactive lifestyleanalogarmbalance testingbasecancer recurrencecancer therapychemotherapydesignefficacy evaluationexperiencefollow-upimprovedmalignant breast neoplasmmarijuana useneurotoxicitypain scalepainful neuropathyphytocannabinoidpillpreclinical studypredicting responseprimary outcomerandomized placebo controlled studyreduce symptomssecondary outcomeside effecttreatment groupvibration
中文摘要
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英文摘要
Project Summary
Over 15 million cancer survivors live in the US, but unfortunately a large proportion of these patients experience
long-term side effects from their treatments. This includes neuropathy, which is typically characterized by
abnormal symptoms in the extremities including tingling, numbness, pain, or burning. When severe and chronic,
neuropathy can interfere with all aspects of a patient’s life, diminishing their quality of life. Unfortunately for these
patients, no therapy has been successful in helping patients entirely eliminate symptoms. With over 30 states
legally providing medical cannabis, it has become increasing popular among cancer patients. However, the
cancer community has very little data in which to guide patients about its use. By evaluating cannabis’s effect
on neuropathy, we will be able to address this important gap in knowledge.
Two important compounds found in medical cannabis are cannabidiol (CBD) and tetrahydrocannabinol (THC).
This clinical trial will randomize breast and colon cancer survivors with chronic chemotherapy-induced peripheral
neuropathy to two kinds of medical cannabis – CBD versus CBD+THC. Patients will be randomized to CBD,
CBD+THC, or placebo and will be treated for 8 weeks. The results of this research are highly relevant to cancer
survivors as a whole because the findings could be potentially applied to other cancer related pain syndromes.
The data generated from this pilot study will provide important preliminary information needed to properly design
a larger randomized clinical trial to evaluate the efficacy of cannabis for the treatment of CIPN. By helping
patients reduce the symptoms of CIPN, we will help improve their quality of life, their ability to return to work, and
their capacity to maintain an active lifestyle, which has increasingly been shown to help reduce the recurrence
of cancer.
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Translational Science in Integrative Oncology: From Bedside, to Bench, to Best P
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批准号:8651596
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项目类别:
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资助金额:$1.2万
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财政年份:2013
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负责人:Richard T Lee
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依托单位:
海外基金