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

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ClinicalTrials.gov Identifier: NCT03557554
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Massage Therapy Foundation
Information provided by (Responsible Party):
Bryan Schneider, Indiana University

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

Condition or disease Intervention/treatment Phase
Breast Cancer Neuropathy Neuropathy;Peripheral Other: Massage Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Massage Therapy
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
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.




Primary Outcome Measures :
  1. Feasibility of Recruitment [ Time Frame: 1 year ]
    rate of enrollment

  2. Feasibility of Retention [ Time Frame: 1 year ]
    rate of drop out or consent withdraw


Secondary Outcome Measures :
  1. Incidence of paclitaxel induced peripheral neuropathy [ Time Frame: 10 months ]
    incidence of paclitaxel induced peripheral neuropathy as measured using the Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionaire

  2. Severity of paclitaxel induced peripheral neuropathy [ Time Frame: 10 months ]
    severity of paclitaxel induced peripheral neuropathy measured by Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionnaire

  3. Rate of pharmacological interventions [ Time Frame: 10 months ]
    pharmacological interventions for paclitaxel induced peripheral neuropathy

  4. Paclitaxel dose modification [ Time Frame: 4 months ]
    rate of dose modifications to paclitaxel treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557554


Contacts
Contact: Alesha Arnold, RN 3172784184 agarnold@iupui.edu

Locations
United States, Indiana
Indiana University Melvin & Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Alesha Arnold, RN       agarnold@iupui.edu   
Principal Investigator: Bryan Schneider, MD         
Sub-Investigator: Alvaro Menendez, MD         
Sponsors and Collaborators
Bryan Schneider
Massage Therapy Foundation
Investigators
Principal Investigator: Bryan Schneider, MD Indiana University

Responsible Party: Bryan Schneider, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT03557554     History of Changes
Other Study ID Numbers: IUSCC-0616 (1709077419)
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bryan Schneider, Indiana University:
Massage
Breast Cancer
Neuropathy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Peripheral Nervous System Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action