N/A
N=7
Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT03348956 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Relative Change in % pO2 — 12.3; 19; 24; 25.3 change in % oxygenation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EPR Oximetry (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change in % pO2 |
12.3; 19; 24; 25.3; 9.5; 42.5 | — |
| SECONDARY Neurologic Examination_ Strength_ Toe Fan |
5; 4.98; 4.89 | — |
| SECONDARY Neurologic Examination_ Strength_ Toe Flex |
5; 4.98; 4.89 | — |
| SECONDARY Neurologic Examination_ Strength_ Inv |
5; 4.96; 4.96 | — |
| SECONDARY Neurologic Examination_ Strength_ Ev |
5; 4.96; 4.96 | — |
| SECONDARY Neurologic Examination_ Strength_ ADF |
5; 5; 5 | — |
| SECONDARY Neurologic Examination_ Vibration Sense_Toe |
6.71; 4.66; 4.53 | — |
| SECONDARY Neurologic Examination_ Vibration Sense_MM |
6.73; 6.44; 5.78 | — |
| SECONDARY Neurologic Examination_ Vibration Sense_Knee |
6.96; 7; 6.10 | — |
| SECONDARY Neurologic Examination_ Vibration Sense_DIP2 |
7.82; 7.78; 7.53 | — |
| SECONDARY Neurologic Examination_ Vibration Sense_DIP5 |
7.72; 7.76; 7.60 | — |
| SECONDARY Neurologic Examination_ Deep Tendon Reflexes _ Biceps |
4.42; 3.28; 2.14 | — |
| SECONDARY Neurologic Examination_ Deep Tendon Reflexes _ Triceps |
4.14; 3.14; 2.57 | — |
| SECONDARY Neurologic Examination_ Deep Tendon Reflexes _ BR |
4.21; 3.28; 1.92 | — |
| SECONDARY Neurologic Examination_ Deep Tendon Reflexes _ Patella |
4; 3.28; 2.71 | — |
| SECONDARY Neurologic Examination_ Deep Tendon Reflexes _ Achilles |
4.14; 1.57; 1 | — |
| SECONDARY Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL |
6.2; 6.3; 3.5 | — |
| SECONDARY Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR |
7.5; 6.4; 5.7 | — |
| SECONDARY Change in Nerve Conduction Metrics (Amplitude)_SURAL |
21.9; 16.6; 19.5 | — |
| SECONDARY Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural |
-0.47; -3.87 | — |
| SECONDARY Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar |
-1.0; -1.7 | — |
| SECONDARY Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural |
-5.2; -2.3 | — |
| SECONDARY Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB |
4.6; 3.4; 3.4 | — |
| SECONDARY Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA |
5.2; 5.1; 5.1 | — |
| SECONDARY Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH |
9.2; 9.0; 10.1 | — |
| SECONDARY Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB |
-1.1; -1.4 | — |
| SECONDARY Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT |
0; 0 | — |
| SECONDARY Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH |
-0.2; 0.9 | — |
| SECONDARY Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV |
1.8; -1.5 | — |
| SECONDARY Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV |
-1.2; -3.5 | — |
| SECONDARY Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV |
2.7; 0.3 | — |
| SECONDARY Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal |
1.6; -2.2 | — |
| SECONDARY Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale |
93.9; 96.3; 100.6 | — |
| SECONDARY Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale |
172.9; 187.1; 187.6 | — |
| SECONDARY Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale |
89.1; 90.6; 91.4 | — |
| SECONDARY Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale |
97.0; 99.3; 97.9 | — |
| SECONDARY Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire |
0.3; 2.2; 3.1 | — |
| SECONDARY Mean Score of Toronto Clinical Neuropathy Scoring System |
2.1; 5.3; 5.0 | — |
| SECONDARY Mean Score of National Cancer Institute - Common Toxicity Criteria |
0.3; 0.7; 1.4 | — |
| SECONDARY Mean Score of Total Neuropathy Scores |
1.3; 6.0; 8.1 | — |
| SECONDARY Mean Score of Survey of Autonomic Symptoms, Column B |
5.9; 6.9; 5.2 | — |
| SECONDARY Mean Score of McGill Pain Visual Analog Scale |
21.0; 27.9; 27.3 | — |
| SECONDARY Mean Scores of Short Form McGill Pain Questionnaire |
3.3; 2.4; 2.3 | — |
| SECONDARY Mean Score of Survey of Autonomic Symptoms, Column A |
2.4; 2.3; 2.0 | — |
| SECONDARY Serum NF-L Levels |
— | — |
Summary
This pilot study will attempt to establish the feasibility of using tissue oxygen measurements and the protein, neurofilament light chain (NF-L), as potential biomarkers for chemotherapy-induced peripheral neuropathy (CIPN). Thirty (30) subjects scheduled to begin taxane-based chemotherapy for breast tumor will be assigned to receive an India ink injection under the skin of the foot. The ink will be used to make up to five (5) 45-minute "electron paramagnetic resonance" (EPR) oximetry readings prior to the start of chemotherapy. Subjects will undergo electrophysiologic assessments including nerve conduction studies, in addition to a neurological examination prior to the start of chemotherapy. Subjects will have the EPR oximetry readings, electrophysiologic tests, and neurological examination two more times: at the halfway point of their chemotherapy treatment -- or at the onset of CIPN symptoms -- and again after chemotherapy has been completed. Subjects will also have blood drawn prior to beginning taxane-based chemotherapy, prior to every scheduled chemotherapy treatment, and after completion of chemotherapy in order to test for neurofilament light chain (NF-L).
Eligibility Criteria
Inclusion Criteria
- Scheduled to receive chemotherapy with taxane compounds for the treatment of breast cancer.
- No prior taxane or platinum chemotherapy prior to enrollment.
- Life expectancy greater than or equal to 12 months.
- Able to provide independent informed consent for the study.
- Able to undergo EPR oximetry
- Age 18 years or older
Exclusion Criteria
- Central nervous system or other impairments that interfere with clinical and electrophysiological assessment.
- Unable to provide independent informed consent.
- Pacemaker or other metallic objects that would be contraindicated for MRI.
- A requirement for supplemental oxygen at baseline, or known, severe chronic obstructive pulmonary disease .
- Previous exposure to neurotoxic chemotherapeutic agents.
Data sourced from ClinicalTrials.gov (NCT03348956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.