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

Sponsor

Bryan Schneider (Other)

Overall Status

Terminated

CT.gov ID

NCT03557554

Collaborator

Massage Therapy Foundation (Other)

Enrollment

Location

Arm

8.2

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

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 :

Feb 8, 2018

Actual Primary Completion Date :

Oct 15, 2018

Actual Study Completion Date :

Oct 15, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Feasibility of Recruitment [1 year]
rate of enrollment
Feasibility of Retention [1 year]
rate of drop out or consent withdraw

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Bryan Schneider
Massage Therapy Foundation

Investigators

Principal Investigator: Bryan Schneider, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bryan Schneider, Principal Investigator, Indiana University

ClinicalTrials.gov Identifier:

NCT03557554

Other Study ID Numbers:

IUSCC-0616 (1709077419)

First Posted:

Jun 15, 2018

Last Update Posted:

Aug 26, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bryan Schneider, Principal Investigator, Indiana University

Massage

Breast Cancer

Neuropathy

Additional relevant MeSH terms:

Breast Neoplasms

Peripheral Nervous System Diseases

Study Results

No Results Posted as of Aug 26, 2019