Investigating the Preventative Ability of Massage Therapy on Paclitaxel Induced Peripheral Neuropathy (PIPN)
Primary Purpose
Breast Cancer, Neuropathy, Neuropathy;Peripheral
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Massage, Breast Cancer, Neuropathy
Eligibility 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
Sites / Locations
- Indiana University Melvin & Bren Simon Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Massage Therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility of Recruitment
rate of enrollment
Feasibility of Retention
rate of drop out or consent withdraw
Secondary Outcome Measures
Incidence of paclitaxel induced peripheral neuropathy
incidence of paclitaxel induced peripheral neuropathy as measured using the Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionaire
Severity of paclitaxel induced peripheral neuropathy
severity of paclitaxel induced peripheral neuropathy measured by Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionnaire
Rate of pharmacological interventions
pharmacological interventions for paclitaxel induced peripheral neuropathy
Paclitaxel dose modification
rate of dose modifications to paclitaxel treatment
Full Information
NCT ID
NCT03557554
First Posted
April 11, 2018
Last Updated
August 21, 2019
Sponsor
Bryan Schneider
Collaborators
Massage Therapy Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03557554
Brief Title
Investigating the Preventative Ability of Massage Therapy on Paclitaxel Induced Peripheral Neuropathy
Acronym
PIPN
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
feasability and recruitment issues
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bryan Schneider
Collaborators
Massage Therapy Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Feasibility study to examine the preventative ability of massage therapy on paclitaxel induced peripheral neuropathy in breast cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neuropathy, Neuropathy;Peripheral
Keywords
Massage, Breast Cancer, Neuropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Massage Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
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 Measure Information:
Title
Feasibility of Recruitment
Description
rate of enrollment
Time Frame
1 year
Title
Feasibility of Retention
Description
rate of drop out or consent withdraw
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of paclitaxel induced peripheral neuropathy
Description
incidence of paclitaxel induced peripheral neuropathy as measured using the Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionaire
Time Frame
10 months
Title
Severity of paclitaxel induced peripheral neuropathy
Description
severity of paclitaxel induced peripheral neuropathy measured by Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionnaire
Time Frame
10 months
Title
Rate of pharmacological interventions
Description
pharmacological interventions for paclitaxel induced peripheral neuropathy
Time Frame
10 months
Title
Paclitaxel dose modification
Description
rate of dose modifications to paclitaxel treatment
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Schneider, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Melvin & Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigating the Preventative Ability of Massage Therapy on Paclitaxel Induced Peripheral Neuropathy
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