Breast CancerPIPNNCT03557554
Investigating the Preventative Ability of Massage Therapy on Paclitaxel Induced Peripheral Neuropathy
A study testing Massage in people with Breast Cancer and Neuropathy, run by Bryan Schneider at 1 site in United States.
Trial summary
Feasibility study to examine the preventative ability of massage therapy on paclitaxel induced peripheral neuropathy in breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Neuropathy, Neuropathy;Peripheral
- What is being tested?
- Massage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 15 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
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
Feasibility study to examine the preventative ability of massage therapy on paclitaxel induced peripheral neuropathy in breast cancer
- Conditions
- Breast Cancer, Neuropathy, Neuropathy;Peripheral
- Being tested
- Massage
- Keywords
- Massage, Breast Cancer, Neuropathy
- Medical subject headings
- Breast Neoplasms, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Massage Therapy | Experimental | 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. Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment
rate of enrollment
Measured: 1 year
Feasibility of Retention
rate of drop out or consent withdraw
Measured: 1 year
Secondary outcomes (4)
Incidence of paclitaxel induced peripheral neuropathy
incidence of paclitaxel induced peripheral neuropathy as measured using the Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionaire
Measured: 10 months
Severity of paclitaxel induced peripheral neuropathy
severity of paclitaxel induced peripheral neuropathy measured by Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionnaire
Measured: 10 months
Rate of pharmacological interventions
pharmacological interventions for paclitaxel induced peripheral neuropathy
Measured: 10 months
Paclitaxel dose modification
rate of dose modifications to paclitaxel treatment
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start8 Feb 2018
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Why it stopped: feasability and recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bryan Schneider
- Sponsor type
- University, hospital or other
- Collaborators
- Massage Therapy Foundation
- Responsible party
- Sponsor-investigator, Bryan Schneider, Indiana University
- Investigators
- Bryan Schneider, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557554
- Sponsor's protocol ID
- IUSCC-0616 (1709077419)
- Acronym
- PIPN
- Status last verified
- Aug 2019
- First submitted
- 11 Apr 2018
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03557554
- Acronym / sponsor ID
- PIPN / IUSCC-0616 (1709077419)
- Conditions
- Breast Cancer, Neuropathy, Neuropathy;Peripheral
- Keywords
- Massage, Breast Cancer, Neuropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: feasability and recruitment issues
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bryan SchneiderUniversity, hospital or other
- Collaborators
- Massage Therapy Foundation
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility study to examine the preventative ability of massage therapy on paclitaxel induced peripheral neuropathy in breast cancer
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Massage Therapy | Experimental | Other: MassageSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageA 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. | Other | Massage Therapy |
Primary outcome
Feasibility of Recruitment
Time frame: 1 year
rate of enrollment
Feasibility of Retention
Time frame: 1 year
rate of drop out or consent withdraw
4 secondary outcomes
Incidence of paclitaxel induced peripheral neuropathy
Time frame: 10 months
Severity of paclitaxel induced peripheral neuropathy
Time frame: 10 months
Rate of pharmacological interventions
Time frame: 10 months
Paclitaxel dose modification
Time frame: 4 months
Results and safety
The study was stopped early (reason given: feasability and recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Schneider, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Breast Cancer and Neuropathy, run by Bryan Schneider at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: feasability and recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.