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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03557554
• Other study ID #: IUSCC-0616 (1709077419)
• Status: Terminated
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: October 15, 2018

Study information

• Verified date: August 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 15, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neuropathy
• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Bryan Schneider	Massage Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Recruitment	rate of enrollment	1 year
Primary	Feasibility of Retention	rate of drop out or consent withdraw	1 year
Secondary	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
Secondary	Severity of paclitaxel induced peripheral neuropathy	severity of paclitaxel induced peripheral neuropathy measured by Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionnaire	10 months
Secondary	Rate of pharmacological interventions	pharmacological interventions for paclitaxel induced peripheral neuropathy	10 months
Secondary	Paclitaxel dose modification	rate of dose modifications to paclitaxel treatment	4 months