Study Stopped
feasability and recruitment issues
Investigating the Preventative Ability of Massage Therapy on Paclitaxel Induced Peripheral Neuropathy
PIPN
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
1 other identifier
interventional
5
1 country
1
Brief Summary
Feasibility study to examine the preventative ability of massage therapy on paclitaxel induced peripheral neuropathy in breast cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Feb 2018
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 8, 2018
CompletedFirst Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2018
CompletedAugust 26, 2019
August 1, 2019
8 months
April 11, 2018
August 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of Recruitment
rate of enrollment
1 year
Feasibility of Retention
rate of drop out or consent withdraw
1 year
Secondary Outcomes (4)
Incidence of paclitaxel induced peripheral neuropathy
10 months
Severity of paclitaxel induced peripheral neuropathy
10 months
Rate of pharmacological interventions
10 months
Paclitaxel dose modification
4 months
Study Arms (1)
Massage Therapy
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \) 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
You may not qualify if:
- )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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bryan Schneiderlead
- Massage Therapy Foundationcollaborator
Study Sites (1)
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan Schneider, MD
Indiana University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 11, 2018
First Posted
June 15, 2018
Study Start
February 8, 2018
Primary Completion
October 15, 2018
Study Completion
October 15, 2018
Last Updated
August 26, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share