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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03557554
Acronym
PIPN
Enrollment
5
Registered
2018-06-15
Start date
2018-02-08
Completion date
2018-10-15
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Neuropathy, Neuropathy;Peripheral

Keywords

Massage, Breast Cancer, Neuropathy

Brief summary

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

Interventions

OTHERMassage

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.

Sponsors

Massage Therapy Foundation
CollaboratorOTHER
Bryan Schneider
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Recruitment1 yearrate of enrollment
Feasibility of Retention1 yearrate of drop out or consent withdraw

Secondary

MeasureTime frameDescription
Incidence of paclitaxel induced peripheral neuropathy10 monthsincidence of paclitaxel induced peripheral neuropathy as measured using the Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionaire
Severity of paclitaxel induced peripheral neuropathy10 monthsseverity of paclitaxel induced peripheral neuropathy measured by Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionnaire
Rate of pharmacological interventions10 monthspharmacological interventions for paclitaxel induced peripheral neuropathy
Paclitaxel dose modification4 monthsrate of dose modifications to paclitaxel treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026