Investigating the Preventative Ability of Massage Therapy on Paclitaxel Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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Feasibility study to examine the preventative ability of massage therapy on paclitaxel induced peripheral neuropathy in breast cancer

Official Title
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A Prospective Feasibility Study Investigating Primary Preventive Ability of Massage Therapy of Paclitaxel-Induced Peripheral Neuropathy in Patients With Newly Diagnosed Breast Cancer Scheduled to Undergo a Paclitaxel Based Regimen

Conditions
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Breast Cancer, Neuropathy, Neuropathy;Peripheral

Intervention / Treatment
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* Other: Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Breast cancer diagnosis 2) Planning to receive chemotherapy treatment with paclitaxel in the curative setting (adjuvant or neoadjuvant) on a weekly or bi-weekly schedule Exclusion Criteria: 1)Diabetes or other neurological disorder 2) Current or previous peripheral neuropathy 3)Previous treatment with paclitaxel 4)Active deep vein thrombosis (DVT) within last 12 months or history of untreated lower extremity DVT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Massage Therapy<br>Subjects who are planning treatment with paclitaxel as part of their standard of care treatment will receive a 20 minute massage prior to each paclitaxel infusion. | Other: Massage<br>* A 20 minute massage protocol will be administered in a chair by a licensed massage therapist no more than 24 hours prior to each paclitaxel infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Recruitment | rate of enrollment | 1 year | 
| Feasibility of Retention | rate of drop out or consent withdraw | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of paclitaxel induced peripheral neuropathy | incidence of paclitaxel induced peripheral neuropathy as measured using the Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionaire | 10 months | 
| Severity of paclitaxel induced peripheral neuropathy | severity of paclitaxel induced peripheral neuropathy measured by Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionnaire | 10 months | 
| Rate of pharmacological interventions | pharmacological interventions for paclitaxel induced peripheral neuropathy | 10 months | 
| Paclitaxel dose modification | rate of dose modifications to paclitaxel treatment | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, Breast Cancer, Neuropathy