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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

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Massage, Breast Cancer, Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

Learn more about this trial

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

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