grant

Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT) Trial

Organization DANA-FARBER CANCER INSTLocation BOSTON, UNITED STATESPosted 1 Apr 2021Deadline 30 Sept 2026
NIHUS FederalResearch GrantFY20252-arm trialASCOAdverse effectsAffectAmerican Society of Clinical OncologyAttentionBreast CancerBrief Pain InventoryCancer CenterCancer PatientCancer SurvivorCancer TreatmentCephalalgiaCephalgiaCephalodyniaChemotherapy-induced peripheral neuropathyClinicalClinical TrialsClinical Trials DesignComplicationControlled Clinical TrialsCranial PainDataData SystemsDisablingDrugsEducationEducational aspectsEquilibriumFall preventionFatigueFemale Reproductive CancerFiberGOGGoalsGynecologic CancerGynecologic Oncology GroupGynecological CancerHead PainHeadacheIT SystemsInformation SystemsInformation Technology SystemsInterventionLack of EnergyLong-term Follow-upLoss of SensationMalignant Breast NeoplasmMalignant Female Reproductive System NeoplasmMalignant Gynecologic NeoplasmMalignant Gynecologic TumorMalignant Neoplasm TherapyMalignant Neoplasm TreatmentMalignant Tumor of the Female Reproductive SystemMeasurementMeasuresMedicationMethodsMind-Body InterventionMind-Body MedicineMuscleMuscle TissueNCI OrganizationNational Cancer InstituteNauseaNon-pharmacologic TherapyNonpharmacologic InterventionNonpharmacologic TherapyNonpharmacologic approachNonpharmacologic treatmentNumbnessNumeric Rating ScaleNumerical ScalePainPainfulParticipantPatient Outcomes AssessmentsPatient Reported MeasuresPatient Reported OutcomesPatientsPharmaceutical PreparationsPhasePhysiatric ProcedurePhysical Medicine ProcedurePhysical TherapeuticsPhysical therapyPhysiotherapyPilot ProjectsPlacebosPreventionQOLQOL improvementQuality of lifeQuestionnairesRandomizedRandomized, Controlled TrialsRecommendationRecoveryResearchRisk ReductionScientistSensorySeveritiesSham TreatmentSymptomsTestingTreatment-related toxicityUnited StatesYogaafferent nerveanti-cancer therapyarmbalancebalance functioncancer therapycancer-directed therapycare as usualcare providerschemotherapydetermine efficacydisabilitydrug/agentduloxetineeffective therapyeffective treatmentefficacy analysisefficacy assessmentefficacy determinationefficacy evaluationefficacy examinationevaluate efficacyexamine efficacyexperiencefall riskflexibilityflexiblefunctional improvementfunctional outcomesglobal healthgynecologic malignancygynecological malignancyhead acheimprove functionimprovedimproved functional outcomesimprovements in QOLimprovements in quality of lifelong-term followupmalignant breast tumormeetingmeetingsmind body approachmind body medicine skillsmind body techniquesmind body therapymind body treatmentsmind body wellnessminimally invasivemultidisciplinarymuscularneuron toxicityneuronal toxicityneurotoxicneurotoxicitynon-drug therapynon-drug treatmentnondrug therapynondrug treatmentpain reductionpharmacologicpilot studypreventing fallsprimary end pointprimary endpointprimary outcomequality of life improvementrandomisationrandomizationrandomized control trialrandomly assignedreduce painreduce riskreduce risksreduce that riskreduce the riskreduce these risksreduces riskreduces the riskreducing riskreducing the riskrisk-reducingsecondary end pointsecondary endpointsensory nervesham therapyside effectstandard of caretherapeutic toxicitytherapy associated toxicitytherapy related toxicitytherapy toxicitytreatment as usualtreatment toxicitytreatment-associated toxicitytrial comparingtrial planningtwo-arm trialusual careusual care armusual care control group
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Full Description

PROJECT SUMMARY
Chemotherapy-induced Peripheral Neuropathy (CIPN) is one of the most harmful, common,

painful, and disabling side effects of many chemotherapy agents and there is no effective

treatment for it. Our pilot phase IIB two-arm trial showed that yoga treatment is associated with

reduced CIPN pain and reduced risk of falls compared to usual care control. We aim to

increase cancer patients’ function and quality of life by identifying effective treatments to

alleviate chemotherapy-related toxicities. The goal of the proposed project is to determine the

efficacy of yoga in treating CIPN pain and improving function, as well as to improve sensory

nerve recovery and reduce the risk of falls in cancer survivors suffering from moderate to

severe CIPN pain. We will conduct a phase III, randomized, education and usual care-

controlled trial with 268 participants to: 1) determine the efficacy of an eight-week yoga

treatment on CIPN symptoms among cancer survivors with moderate to severe CIPN pain; 2)

evaluate the effect of yoga versus education control and usual care on improving flexibility and

reducing the risk of falls; and 3) evaluate the effect of yoga versus education control and usual

care on quality of life and sensory fiber functioning.

Grant Number: 5R01CA251470-06
NIH Institute/Center: NIH

Principal Investigator: Ting Bao

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