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Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastrointestinal Cancer Colorectal Cancer | Diagnostic Test: Ultrasound - Serial and Tibial Nerve Procedure: Skin Biopsy Other: Abbreviated Neurologic Exam Other: Blood draw Diagnostic Test: Nerve Conduction Study Other: QLQ-CIPN20 Questionnaire Administration | Not Applicable |
Primary Objectives
I. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults.
Secondary Objective
I. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults.
II. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction study changes in the same oxaliplatin-induced peripheral neuropathy patients.
III. To determine if the above changes in nerve cross-sectional area correlate with changes on a self-reported neuropathy scale (QLQ-CIPN20) in the same oxaliplatin-induced peripheral neuropathy patients.
IV. To determine if the above changes in nerve cross-sectional area correlate with intraepidermal nerve fiber density changes on skin biopsy in the same oxaliplatin-induced peripheral neuropathy patients.
Exploratory Objectives I. To assess activated mast cells in skin biopsies in oxaliplatin-induced peripheral neuropathy patients in relation to severity of symptoms and above findings.
II. To assess serum inflammatory markers in oxaliplatin-induced peripheral neuropathy patients in relation to severity of symptoms and above findings.
III. Exploratory Cohort (Oxaliplatin-induced peripheral neuropathy, OIPN) Objectives
IV. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and OIPN patients
V. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and oxaliplatin-induced peripheral neuropathy patients
VI. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction study changes in the same oxaliplatin-induced peripheral neuropathy patients
VII. To determine if the above changes in nerve cross-sectional area correlate with changes on a self-reported neuropathy scale (QLQ-CIPN20) in the same oxaliplatin-induced peripheral neuropathy patients
VIII. To determine if the above changes in nerve cross-sectional area correlate with intraepidermal nerve fiber density changes on skin biopsy in the same oxaliplatin-induced peripheral neuropathy patients
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | A Pilot Study Using Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy |
| Actual Study Start Date : | December 17, 2019 |
| Estimated Primary Completion Date : | August 2021 |
| Estimated Study Completion Date : | August 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ultrasound
Undergo peripheral nerve ultrasound
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Diagnostic Test: Ultrasound - Serial and Tibial Nerve
Participants will undergo a serial and tibial nerve ultrasound
Procedure: Skin Biopsy Two skin biopsies will be obtained as 4.0 mm punch biopsies at distal end of leg in sural nerve territory (10 cm above lateral malleolus) and from the thigh
Other: Abbreviated Neurologic Exam Exam to include strength assessment of the tibialis anterior and gastrocnemius and deep tendon reflex exam of the Achilles on the limb to be examined by nerve conduction velocity and ultrasound.
Other: Blood draw 12 ml blood sample will be taken
Diagnostic Test: Nerve Conduction Study Sural and tibial nerve assessments
Other: QLQ-CIPN20 Questionnaire Administration Self-reported neuropathy scoring questionnaire completed same day as blood draw.
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- Tibial Nerve Cross-Sectional Area Comparison [ Time Frame: Up to 30 days ]Tibial nerve cross-sectional area determined by ultrasound in oxaliplatin-induced peripheral neuropathy patients will be transformed to compare to historical data previously collected from healthy adults and oxaliplatin-induced peripheral neuropathy patients using analysis of variance (ANOVA).
- Sural Nerve Cross-Sectional Area Comparison [ Time Frame: Up to 30 days ]Sural nerve cross-sectional area determined by ultrasound in oxaliplatin-induced peripheral neuropathy patients will be transformed to compare to historical data previously collected from healthy adults and oxaliplatin-induced peripheral neuropathy patients using analysis of variance (ANOVA).
- Amplitude of Nerve Response of Tibial Nerve [ Time Frame: Up to 30 days ]Amplitude will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
- Amplitude of Nerve Response of Sural Nerve [ Time Frame: Up to 30 days ]Amplitude will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
- Distal Latency of Nerve Response of Tibial Nerve [ Time Frame: Up to 30 days ]Distal latency will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
- Distal Latency of Nerve Response of Sural Nerve [ Time Frame: Up to 30 days ]Distal latency will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
- Conduction Velocity of Nerve Response of Tibial Nerve [ Time Frame: Up to 30 days ]Conduction velocity will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
- Conduction Velocity of Nerve Response of Sural Nerve [ Time Frame: Up to 30 days ]Conduction velocity will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) Questionnaire [ Time Frame: Up to 30 days ]A 20-item self-reported neuropathy score questionnaire for participants to report neuropathy symptoms or problems. Scoring ranges from 1-4, 1 being not at all, 4 being very much.
- Reduction of Intraepidermal Nerve Fiber Density [ Time Frame: Up to 30 days ]Biopsies will be taken from the distal leg or proximal thigh to evaluate peripheral neuropathy. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and intraepidermal nerve fiber density.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Gastrointestinal cancer
- Colorectal cancer (any stage)
- Previously or currently receiving oxaliplatin -based chemotherapy.
- Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to oxaliplatin -based therapy.
- Ability and willingness to understand and sign an informed consent.
Exclusion Criteria:
- Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of oxaliplatin chemotherapy.
- Unable to provide history.
| Contact: Ashley Fansler, RN | 336-716-5440 | arcarrol@wakehealth.edu |
| United States, North Carolina | |
| Wake Forest Baptist Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Ashley Fansler, RN | |
| Principal Investigator: Roy Strowd, MD | |
| Principal Investigator: | Roy Strowd, MD | Wake Forest University Health Sciences |
| Tracking Information | |||||||
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| First Submitted Date ICMJE | May 17, 2019 | ||||||
| First Posted Date ICMJE | May 22, 2019 | ||||||
| Last Update Posted Date | December 19, 2020 | ||||||
| Actual Study Start Date ICMJE | December 17, 2019 | ||||||
| Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Tibial Nerve Cross-Sectional Area Comparison [ Time Frame: Up to 30 days ] Tibial nerve cross-sectional area determined by ultrasound in oxaliplatin-induced peripheral neuropathy patients will be transformed to compare to historical data previously collected from healthy adults and oxaliplatin-induced peripheral neuropathy patients using analysis of variance (ANOVA).
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy | ||||||
| Official Title ICMJE | A Pilot Study Using Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy | ||||||
| Brief Summary | This pilot clinical trial studies how well ultrasound works in detecting oxaliplatin-induced neuropathy in patients with gastrointestinal cancer. Ultrasound may work better in diagnosing and detecting neuropathy in gastrointestinal cancer patients treated with the chemotherapy drug called a oxaliplatin. | ||||||
| Detailed Description |
Primary Objectives I. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults. Secondary Objective I. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults. II. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction study changes in the same oxaliplatin-induced peripheral neuropathy patients. III. To determine if the above changes in nerve cross-sectional area correlate with changes on a self-reported neuropathy scale (QLQ-CIPN20) in the same oxaliplatin-induced peripheral neuropathy patients. IV. To determine if the above changes in nerve cross-sectional area correlate with intraepidermal nerve fiber density changes on skin biopsy in the same oxaliplatin-induced peripheral neuropathy patients. Exploratory Objectives I. To assess activated mast cells in skin biopsies in oxaliplatin-induced peripheral neuropathy patients in relation to severity of symptoms and above findings. II. To assess serum inflammatory markers in oxaliplatin-induced peripheral neuropathy patients in relation to severity of symptoms and above findings. III. Exploratory Cohort (Oxaliplatin-induced peripheral neuropathy, OIPN) Objectives IV. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and OIPN patients V. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and oxaliplatin-induced peripheral neuropathy patients VI. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction study changes in the same oxaliplatin-induced peripheral neuropathy patients VII. To determine if the above changes in nerve cross-sectional area correlate with changes on a self-reported neuropathy scale (QLQ-CIPN20) in the same oxaliplatin-induced peripheral neuropathy patients VIII. To determine if the above changes in nerve cross-sectional area correlate with intraepidermal nerve fiber density changes on skin biopsy in the same oxaliplatin-induced peripheral neuropathy patients |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: Ultrasound
Undergo peripheral nerve ultrasound
Interventions:
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
20 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | August 2021 | ||||||
| Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03958747 | ||||||
| Other Study ID Numbers ICMJE | IRB00059662 P30CA012197 ( U.S. NIH Grant/Contract ) WFBCCC 97219 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center ) |
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| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Wake Forest University Health Sciences | ||||||
| Study Sponsor ICMJE | Wake Forest University Health Sciences | ||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||
| Investigators ICMJE |
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| PRS Account | Wake Forest University Health Sciences | ||||||
| Verification Date | December 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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