Breast CancerSENSENCT04932031
Risk Prediction of Taxane Chemotherapy-Induced Peripheral Neuropathy
An observational study of Breast Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Sapere Bio at 2 sites in United States.
Trial summary
This is an observational study to discover risk factors of chemotherapy-induced peripheral neuropathy (CIPN) in 350 patients with early stage breast cancer undergoing taxane-based chemotherapy at two main sites (University of North Carolina at Chapel Hill (UNC) Hospital, including Rex Hospital, and the University of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Aging
- How many people
- 123 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 May 2022to 1 Nov 2023
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female study participants (≥18 years) with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel
Who may be able to join
- Study participants must meet all of the following inclusion criteria to participate in the study:
- Adult female study participants (≥18 years) with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel
- Study participants must be capable and willing to provide informed consent, and be willing and able to complete the study questionnaires during the study
Who cannot join
- Study participants who fulfill any of the following criteria will be excluded:
- Patients with metastatic breast cancer
- History of other cancers (except squamous and basal cell carcinoma)
- Autoimmune disorders
- Presence of major active infection for which antibiotics and/or antivirals are prescribed within the last 14 days (chronic or acute, eg, sepsis, HIV, pneumonia, active COVID infection)
- Pregnant women
- Participation in an additional study at the time of enrollment where the intervention could potentially alter CIPN risk (unless in the control arm)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
UNC Hospitals Adult Oncology Clinics
Chapel Hill, North Carolina, 27514
About this study
Official title: Systemic Assessment of CIPN Risk Using Molecular Aging Trajectories
This is an observational study to discover risk factors of chemotherapy-induced peripheral neuropathy (CIPN) in 350 patients with early stage breast cancer undergoing taxane-based chemotherapy at two main sites (University of North Carolina at Chapel Hill (UNC) Hospital, including Rex Hospital, and the University of Alabama at Birmingham (UAB) Hospital). The primary purpose of this study to explore patient- and procedure-based variables that identify patients at risk for developing CIPN during chemotherapy.
Read the detailed description
Chemotherapy-induced peripheral neuropathy is common and provokes pain, poor QoL, and loss of independence, as well as increases the risk of falls and opioid addiction. Beyond the inciting agents, risk factors for CIPN are not understood or systematically evaluated in clinical practice, precluding prevention. Therefore, a clinical decision tool to predict an individual patient's risk of neuropathy remains a critical unmet need. A diagnostic test that predicts CIPN risk in this clinical context would provide an essential clinical-decision tool to guide treatment and post-treatment care in breast cancer, prevent CIPN occurrence, and improve patient outcomes.
Investigators' pilot data uncovered a strong association between cellular senescence and CIPN. In this prospective, observational study of participants with early-stage breast cancer, the investigators will assess the contribution of senescence and clinical variables. The investigators will determine the ability of these factors to identify patients at risk for CIPN during chemotherapy and up to one year after the last dose of taxane-based chemotherapy. This study will employ both patient- and clinician reported CIPN scoring systems.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Adult females with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between baseline and the peak EORTC QLQ CIPN20 score during chemotherapy (continuous)
EORTC QLQ CIPN20
Measured: 12 weeks
Secondary outcomes (6)
Incidence of grade 2 or higher CTCAE-CIPN during chemotherapy (binary)
CTCAE-CIPN
Measured: 12 weeks
Dose reduction or discontinuation of chemotherapy (<85% of planned total dose delivered) (binary)
dose reduction or discontinuation
Measured: 12 weeks
Dose reduction or discontinuation of the taxane portion of the chemotherapy, if administered separately from the rest of the chemotherapy agents (<85% of planned total dose delivered) (binary)
dose reduction or discontinuation
Measured: 12 weeks
Change between baseline and the EORTC QLQ-CIPN20 score at one year after the last taxane-based chemotherapy dose (continuous)
EORTC QLQ-CIPN20
Measured: 1 year
Presence of CIPN at one year after the last taxane based chemotherapy dose that is an EORTC QLQ-CIPN20 score of 3 points or higher than baseline (binary)
EORTC QLQ-CIPN20
Measured: 1 year
Presence of grade 2 or higher CTCAE-CIPN at one year after the last taxane-based chemotherapy dose (binary)
CTCAE-CIPN
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start25 May 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Why it stopped: under enrollment for primary endpoint analysis
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sapere Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of North Carolina, University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Natalia Mitin, PhD, Principal investigator, Sapere Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932031
- Sponsor's protocol ID
- SB-2101
- Acronym
- SENSE
- Status last verified
- Nov 2023
- First submitted
- 12 Jun 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Assessment of CIPN Risk Using Molecular Aging Trajectories
- ClinicalTrials.gov ID
- NCT04932031
- Acronym / sponsor ID
- SENSE / SB-2101
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: under enrollment for primary endpoint analysis
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Sapere BioIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of North Carolina, University of Alabama at Birmingham
- Study start
- 25 May 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 Jun 2021 (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.
This is an observational study to discover risk factors of chemotherapy-induced peripheral neuropathy (CIPN) in 350 patients with early stage breast cancer undergoing taxane-based chemotherapy at two main sites (University of North Carolina at Chapel Hill (UNC) Hospital, including Rex Hospital, and the University of Alabama at Birmingham (UAB) Hospital). The primary purpose of this study to explore patient- and procedure-based variables that identify patients at risk for developing CIPN during chemotherapy.
Detailed description
Chemotherapy-induced peripheral neuropathy is common and provokes pain, poor QoL, and loss of independence, as well as increases the risk of falls and opioid addiction. Beyond the inciting agents, risk factors for CIPN are not understood or systematically evaluated in clinical practice, precluding prevention. Therefore, a clinical decision tool to predict an individual patient's risk of neuropathy remains a critical unmet need. A diagnostic test that predicts CIPN risk in this clinical context would provide an essential clinical-decision tool to guide treatment and post-treatment care in breast cancer, prevent CIPN occurrence, and improve patient outcomes.
Investigators' pilot data uncovered a strong association between cellular senescence and CIPN. In this prospective, observational study of participants with early-stage breast cancer, the investigators will assess the contribution of senescence and clinical variables. The investigators will determine the ability of these factors to identify patients at risk for CIPN during chemotherapy and up to one year after the last dose of taxane-based chemotherapy. This study will employ both patient- and clinician reported CIPN scoring systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Adult females with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female study participants (≥18 years) with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel
Key inclusion criteria (3 listed)
- Study participants must meet all of the following inclusion criteria to participate in the study:
- Adult female study participants (≥18 years) with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel
- Study participants must be capable and willing to provide informed consent, and be willing and able to complete the study questionnaires during the study
Key exclusion criteria (7 listed)
- Patients with metastatic breast cancer
- History of other cancers (except squamous and basal cell carcinoma)
- Autoimmune disorders
- Presence of major active infection for which antibiotics and/or antivirals are prescribed within the last 14 days (chronic or acute, eg, sepsis, HIV, pneumonia, active COVID infection)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change between baseline and the peak EORTC QLQ CIPN20 score during chemotherapy (continuous)
Time frame: 12 weeks
EORTC QLQ CIPN20
6 secondary outcomes
Incidence of grade 2 or higher CTCAE-CIPN during chemotherapy (binary)
Time frame: 12 weeks
Dose reduction or discontinuation of chemotherapy (<85% of planned total dose delivered) (binary)
Time frame: 12 weeks
Dose reduction or discontinuation of the taxane portion of the chemotherapy, if administered separately from the rest of the chemotherapy agents (<85% of planned total dose delivered) (binary)
Time frame: 12 weeks
Change between baseline and the EORTC QLQ-CIPN20 score at one year after the last taxane-based chemotherapy dose (continuous)
Time frame: 1 year
Presence of CIPN at one year after the last taxane based chemotherapy dose that is an EORTC QLQ-CIPN20 score of 3 points or higher than baseline (binary)
Time frame: 1 year
Presence of grade 2 or higher CTCAE-CIPN at one year after the last taxane-based chemotherapy dose (binary)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: under enrollment for primary endpoint analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- 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.
Natalia Mitin, PhD principal investigator
Sapere Bio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chemotherapy-induced Peripheral Neuropathy, run by Sapere Bio at 2 sites 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 3 inclusion and 7 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 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: under enrollment for primary endpoint analysis). 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?
Change between baseline and the peak EORTC QLQ CIPN20 score during chemotherapy (continuous) (time frame: 12 weeks). 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 3 Nov 2023.