Hematopoietic and Lymphoid Cell NeoplasmNCT05790538
Predicting the Impact of Treatment Toxicities on Health During Cancer ( PATTERN )
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This study investigates the effects of treatment from chemotherapy for cancer on symptoms, function, and falls during treatment and through the recovery phase of cancer care. The goal is to identify simple tests that can help medical providers predict which and when patients show increased risk for falls and… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Assessment of Therapy Complications, Electronic Health Record Review and Medical Device Usage and Evaluation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2020to 6 Jun 2025
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage I-III cancer without neurologic involvement who are scheduled to receive neurotoxic chemotherapy at Oregon Health \& Science University (OHSU) Knight Cancer Institute
Who may be able to join
- Age 40-85 years old on date of enrollment.
- Diagnosed with stage I-III cancer, or stage IV cancer considered curable, other than cancers or metastases in the brain or spinal cord.
- Scheduled to receive any neurotoxic chemotherapy including taxane derivative, platinum complex, and/or vinca alkyloids
Who cannot join
- Previously received neurotoxic chemotherapy
- Cognitive difficulties that preclude answering the survey questions, participating in the performance tests, or giving informed consent
- A medical condition, movement or neurological disorder, or medication use that contraindicates participation in mobility testing and/or that confounds the ability to detect treatment-related changes in balance and mobility. Specific medical conditions include, but are not limited to, severe dystrophy, severe spasticity, epilepsy, seizures, Alzheimer's and dementia, while physical conditions include a severe balance disorder (i.e., later-stage Parkinson's, stroke), inability to ambulate (use of an assistive device permitted), inability to stand for 3 minutes, or severe hearing or vision problem
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: PATTERN: Predicting the Impact of Treatment Toxicities on Health During Cancer
This study investigates the effects of treatment from chemotherapy for cancer on symptoms, function, and falls during treatment and through the recovery phase of cancer care. The goal is to identify simple tests that can help medical providers predict which and when patients show increased risk for falls and functional decline and informing rehabilitation providers about which mobility deficits to target.
Read the detailed description
Aggressive treatments for cancer have improved survival, but often cause serious long-term adverse effects on daily life that last for many years. Chemotherapy-induced peripheral neuropathy (CIPN) is a persistent cancer treatment-related symptom that may negatively impact physical functioning, falls, and quality of life.
The persistence of CIPN symptoms and their relationship with life-threatening falls and disability point to a gap in oncology and follow-up care. A critical first step toward filling this gap is to characterize the natural trajectories of symptoms, functioning, and falls across the in-treatment and recovery phases of cancer care.
This study will prospectively enroll 200 adults with cancer that are scheduled to receive neurotoxic chemotherapy at the Portland campus of Oregon Health \& Science University, 5 OHSU Knight Cancer Institute community hematology-oncology clinics, and OHSU research affiliate sites. Data collection occurs at patients' routine clinical appointments and at home via electronic surveys and passive monitoring devices. In the clinic, data collection occurs at 4-6 week intervals during treatment according to each patient's infusion schedule, and then approximately every 3 months for an additional year during routine follow-up care. Clinic-based assessments include tests of perceived sensation (tuning fork, monofilament, and biothesiometer), upper body strength (handgrip dynamometry), lower body strength (chair stand test), static balance (postural sway), and dynamic balance (Timed Up and Go test). Non-clinic-based data collection occurs weekly and assesses symptoms and falls via web-based surveys. At time points corresponding to clinic testing visits, participants are sent home with passive monitoring devices (instrumented socks and wrist-worn activity monitors) that measure physical activity and mobility.
PRIMARY OBJECTIVE:
- To characterize trajectories of chemotherapy induced peripheral neuropathy (CIPN) symptoms and physical functioning (physical activity, mobility, self-report functioning and disability) and capture the variability in different patient trajectories across treatment and one year of recovery among persons receiving neurotoxic chemotherapy for cancer.
SECONDARY OBJECTIVE:
- Determine whether or not patient characteristics alone can predict symptom and functioning trajectories or if adding clinical factors and simple tests of mobility significantly improves predictive capacity.
OUTLINE:
Patients complete surveys and clinic assessments at baseline, every 4-6 weeks during chemotherapy, and then every 3 months for 1 year after completion of chemotherapy. Clinic assessments include tests of neuropathy, upper and lower body strength, balance, and mobility. Patients complete weekly symptom surveys and wear instrumented socks and an activity monitor at regular intervals at home during chemotherapy treatment and for 1 year after completion of chemotherapy. Patients' medical records are also reviewed.
- Being tested
- Assessment of Therapy Complications, Electronic Health Record Review, Medical Device Usage and Evaluation, Survey Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Therapy ComplicationsProcedure or surgery
Complete clinic assessments
Electronic Health Record ReviewOther
Medical records are reviewed
Medical Device Usage and EvaluationOther
Wear SmartSocks
Medical Device Usage and EvaluationOther
Wear activity monitor
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey, assessment, SmartSocks, monitor) | Patients complete surveys and clinic assessments at baseline, every 4-6 weeks during chemotherapy, and then every 3 months for 1 year after completion of chemotherapy. Clinic assessments include tests of neuropathy, upper and lower body strength, balance, and mobility. Patients complete weekly symptom surveys and wear instrumented socks and an activity monitor at regular intervals at home during chemotherapy treatment and for 1 year after completion of chemotherapy. Patients' medical records are also reviewed. After main study, patients may optionally complete surveys every 6 months for up to 5 years on study. Receives: Procedure: Assessment of Therapy Complications; Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported neuropathy
Measured using the neuropathy subscale of the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity (FACT-GOG-NTX-13) questionnaire, which assesses the presence, severity and impact of neuropathy symptoms in patients receiving neurotoxic chemotherapy. The scale ranges from 0-52, with lower scores indicating worse quality of life due to neuropathy.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in patient-reported neuropathy
Measured using the Patient-Reported Outcomes version of the Common Toxicity Criteria and Adverse Events version 1.0 (PRO-CTCAE™) reporting tool. Two items from the PRO-CTCAE™ ask if the patient experienced numbness or tingling in the hands or feet in the last 7 days using a 5-pt scale (0=none to 4=very severe) and how much the symptom interfered with their daily life using a 5-pt scale (0=not at all to 4=very much).
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in perceived disability
Measured using the disability component of the Late-Life Function and Disability Instrument (LLFDI) which assesses disability in terms of frequency and limitation in performing 16 life tasks. Scores range from 0 to 100, with higher scores indicating less disability.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in daily functional mobility
Measured using instrumented socks (APDM.com) with inertial sensors embedded into neoprene ankle wraps. Patients wear the instrumented socks during waking hours over 7-day periods that correspond to each in-clinic assessment.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in daily physical activity
Measured using ActiGraph GT9X Link devices. The ActiGraph algorithms generate accurate and reliable data on total energy expenditure (kcal/d). Patients wear the devices over 7-day periods that correspond to each in-clinic assessment.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Secondary outcomes (10)
Falls
Falls over the past 12 months will be assessed retrospectively at baseline and prospectively at weekly intervals using in-house surveys. These surveys ask subjects about the number of falls, the number of injurious falls, and medical care resulting from a fall during the observation period.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in quality of life
Measured using the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire for Cancer (EORTC-QLQ-C30). Global quality of life and subdomains of quality of life are scored from 0-100, with higher scores indicating better quality of life.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in patient-reported symptoms
Assessed weekly with the Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE™) reporting tool items. The PRO-CTCAE™ uses 5-pt scales to assess the severity (0=none to 4=very severe), frequency (0=never to 4=almost constantly), and interference (0=not at all to 4=very much) of symptoms in daily life within the previous 7 days.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in objective loss of perceived sensation
Measured using a tuning fork test.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in objective loss of perceived sensation
Measured using biothesiometry.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in upper extremity strength
Measured by handgrip dynamometry.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in static balance
Measured by a postural sway test that assesses how well a person maintains their balance during 30 seconds of quiet standing using Mobility Lab sensors and software (APDM.com). Increased sway indicates poor balance control and is associated with increased risk of falls.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in functional mobility
Measured by the Timed Up and Go (TUG) test. The TUG test evaluates the time that it takes a person to rise from a chair, walk 3 meters, then turn around and return to the chair in a seated position. Slower TUG times are associated with an increased risk of falls and disability.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in objective functional strength
Measured by a timed chair stand test (seconds required to rise from a chair 5 times). Chair stand time >12 seconds has been shown to predict a 2.4 increased risk of falls in older adults.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in skeletal muscle index
Clinically acquired abdominal and thoracic computed tomography images will be segmented into fat and lean tissue compartments according to their non-overlapping radiodensity ranges. Skeletal muscle index is calculated as skeletal muscle cross-sectional area divided by height in meters squared.
Measured: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start22 Oct 2020
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri Winters, OHSU Knight Cancer Institute
- Investigators
- Kerri Winters-Stone, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790538
- Sponsor's protocol ID
- STUDY00021969
- Other IDs
- NCI-2021-05944, STUDY00021969, R01CA248059
- Status last verified
- Dec 2025
- First submitted
- 23 Feb 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Winters-Stone KM, Krasnow SM, Horak FB, Mancini M, Cameron MH, Dieckmann NF, Stoyles SA, Roeland EJ. Identifying trajectories and predictors of chemotherapy-induced peripheral neuropathy symptoms, physical functioning, and falls across treatment and recovery in adults treated with neurotoxic chemotherapy: the PATTERN observational study protocol (NCT05790538). BMC Cancer. 2023 Nov 10;23(1):1087. doi: 10.1186/s12885-023-11546-2.
PubMed 37946117
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATTERN: Predicting the Impact of Treatment Toxicities on Health During Cancer
- ClinicalTrials.gov ID
- NCT05790538
- Acronym / sponsor ID
- STUDY00021969
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 30 Mar 2023 (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 study investigates the effects of treatment from chemotherapy for cancer on symptoms, function, and falls during treatment and through the recovery phase of cancer care. The goal is to identify simple tests that can help medical providers predict which and when patients show increased risk for falls and functional decline and informing rehabilitation providers about which mobility deficits to target.
Detailed description
Aggressive treatments for cancer have improved survival, but often cause serious long-term adverse effects on daily life that last for many years. Chemotherapy-induced peripheral neuropathy (CIPN) is a persistent cancer treatment-related symptom that may negatively impact physical functioning, falls, and quality of life.
The persistence of CIPN symptoms and their relationship with life-threatening falls and disability point to a gap in oncology and follow-up care. A critical first step toward filling this gap is to characterize the natural trajectories of symptoms, functioning, and falls across the in-treatment and recovery phases of cancer care.
This study will prospectively enroll 200 adults with cancer that are scheduled to receive neurotoxic chemotherapy at the Portland campus of Oregon Health \& Science University, 5 OHSU Knight Cancer Institute community hematology-oncology clinics, and OHSU research affiliate sites. Data collection occurs at patients' routine clinical appointments and at home via electronic surveys and passive monitoring devices. In the clinic, data collection occurs at 4-6 week intervals during treatment according to each patient's infusion schedule, and then approximately every 3 months for an additional year during routine follow-up care. Clinic-based assessments include tests of perceived sensation (tuning fork, monofilament, and biothesiometer), upper body strength (handgrip dynamometry), lower body strength (chair stand test), static balance (postural sway), and dynamic balance (Timed Up and Go test). Non-clinic-based data collection occurs weekly and assesses symptoms and falls via web-based surveys. At time points corresponding to clinic testing visits, participants are sent home with passive monitoring devices (instrumented socks and wrist-worn activity monitors) that measure physical activity and mobility.
PRIMARY OBJECTIVE:
- To characterize trajectories of chemotherapy induced peripheral neuropathy (CIPN) symptoms and physical functioning (physical activity, mobility, self-report functioning and disability) and capture the variability in different patient trajectories across treatment and one year of recovery among persons receiving neurotoxic chemotherapy for cancer.
SECONDARY OBJECTIVE:
- Determine whether or not patient characteristics alone can predict symptom and functioning trajectories or if adding clinical factors and simple tests of mobility significantly improves predictive capacity.
OUTLINE:
Patients complete surveys and clinic assessments at baseline, every 4-6 weeks during chemotherapy, and then every 3 months for 1 year after completion of chemotherapy. Clinic assessments include tests of neuropathy, upper and lower body strength, balance, and mobility. Patients complete weekly symptom surveys and wear instrumented socks and an activity monitor at regular intervals at home during chemotherapy treatment and for 1 year after completion of chemotherapy. Patients' medical records are also reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey, assessment, SmartSocks, monitor) | – | Procedure: Assessment of Therapy Complications, Other: Electronic Health Record Review, Other: Medical Device Usage and Evaluation, Other: Survey AdministrationPatients complete surveys and clinic assessments at baseline, every 4-6 weeks during chemotherapy, and then every 3 months for 1 year after completion of chemotherapy. Clinic assessments include tests of neuropathy, upper and lower body strength, balance, and mobility. Patients complete weekly symptom surveys and wear instrumented socks and an activity monitor at regular intervals at home during chemotherapy treatment and for 1 year after completion of chemotherapy. Patients' medical records are also reviewed. After main study, patients may optionally complete surveys every 6 months for up to 5 years on study. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage I-III cancer without neurologic involvement who are scheduled to receive neurotoxic chemotherapy at Oregon Health \& Science University (OHSU) Knight Cancer Institute
Key inclusion criteria (3 listed)
- Age 40-85 years old on date of enrollment.
- Diagnosed with stage I-III cancer, or stage IV cancer considered curable, other than cancers or metastases in the brain or spinal cord.
- Scheduled to receive any neurotoxic chemotherapy including taxane derivative, platinum complex, and/or vinca alkyloids
Key exclusion criteria (3 listed)
- Previously received neurotoxic chemotherapy
- Cognitive difficulties that preclude answering the survey questions, participating in the performance tests, or giving informed consent
- A medical condition, movement or neurological disorder, or medication use that contraindicates participation in mobility testing and/or that confounds the ability to detect treatment-related changes in balance and mobility. Specific medical conditions include, but are not limited to, severe dystrophy, severe spasticity, epilepsy, seizures, Alzheimer's and dementia, while physical conditions include a severe balance disorder (i.e., later-stage Parkinson's, stroke), inability to ambulate (use of an assistive device permitted), inability to stand for 3 minutes, or severe hearing or vision problem
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 |
|---|---|---|
| Assessment of Therapy ComplicationsComplete clinic assessments | Procedure or surgery | Observational (survey, assessment, SmartSocks, monitor) |
| Electronic Health Record ReviewMedical records are reviewed | Other | Observational (survey, assessment, SmartSocks, monitor) |
| Medical Device Usage and EvaluationWear SmartSocks | Other | Observational (survey, assessment, SmartSocks, monitor) |
| Medical Device Usage and EvaluationWear activity monitor | Other | Observational (survey, assessment, SmartSocks, monitor) |
| Survey AdministrationComplete survey | Other | Observational (survey, assessment, SmartSocks, monitor) |
Primary outcome
Change in patient-reported neuropathy
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Measured using the neuropathy subscale of the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity (FACT-GOG-NTX-13) questionnaire, which assesses the presence, severity and impact of neuropathy symptoms in patients receiving neurotoxic chemotherapy. The scale ranges from 0-52, with lower scores indicating worse quality of life due to neuropathy.
Change in patient-reported neuropathy
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Measured using the Patient-Reported Outcomes version of the Common Toxicity Criteria and Adverse Events version 1.0 (PRO-CTCAE™) reporting tool. Two items from the PRO-CTCAE™ ask if the patient experienced numbness or tingling in the hands or feet in the last 7 days using a 5-pt scale (0=none to 4=very severe) and how much the symptom interfered with their daily life using a 5-pt scale (0=not at all to 4=very much).
Change in perceived disability
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Measured using the disability component of the Late-Life Function and Disability Instrument (LLFDI) which assesses disability in terms of frequency and limitation in performing 16 life tasks. Scores range from 0 to 100, with higher scores indicating less disability.
Change in daily functional mobility
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Measured using instrumented socks (APDM.com) with inertial sensors embedded into neoprene ankle wraps. Patients wear the instrumented socks during waking hours over 7-day periods that correspond to each in-clinic assessment.
Change in daily physical activity
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Measured using ActiGraph GT9X Link devices. The ActiGraph algorithms generate accurate and reliable data on total energy expenditure (kcal/d). Patients wear the devices over 7-day periods that correspond to each in-clinic assessment.
10 secondary outcomes
Falls
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in quality of life
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in patient-reported symptoms
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in objective loss of perceived sensation
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in objective loss of perceived sensation
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in upper extremity strength
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in static balance
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in functional mobility
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in objective functional strength
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Change in skeletal muscle index
Time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 37946117Winters-Stone KM, Krasnow SM, Horak FB, Mancini M, Cameron MH, Dieckmann NF, Stoyles SA, Roeland EJ. Identifying trajectories and predictors of chemotherapy-induced peripheral neuropathy symptoms, physical functioning, and falls across treatment and recovery in adults treated with neurotoxic chemotherapy: the PATTERN observational study protocol (NCT05790538). BMC Cancer. 2023 Nov 10;23(1):1087. doi: 10.1186/s12885-023-11546-2.
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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.
Kerri Winters-Stone principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Dec 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in patient-reported neuropathy (time frame: Baseline up to 1 year after completion of chemotherapy (average of 16 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05790538, which also lists 1 linked publication.
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 10 Dec 2025.