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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Sygehus Lillebaelt | OTHER |
| Sonderborg Hospital | OTHER_GOV |
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Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.
The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles.
Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4.
The primary endpoint of the study is if serum NFL>100 pg/ml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastcancer patients | A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across three trial sites. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| NFL level correlation | The primary endpoint of the study is if serum NFL>100 pg/ml after first cycle (one cycle equals 3 weeks) of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy. | Before treatment start and during four cycles (one cycle equals 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Paclitaxel exposure | To measure if high concentration of paclitaxel exposure is correlated to high NFL level in blood | Before treatment start and during four cycles (one cycle equals 3 weeks) |
| Genes and PIPN |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across four trial sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ditte Bork Iversen, MSc Pharm, PhD | Contact | +45 65 50 23 52 | dbiversen@health.sdu.dk | |
| Tore B. Stage, Prof | Contact | +45 65 50 36 78 | tstage@health.sdu.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ditte Bork Iversen | University of Southern Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
Data on individual participants is not allowed due to GDPR
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The investigators are taking blood samples to analyze the NFL level, paclitaxel concentration, and looking at DNA sequencing associated with PIPN. The investigators will also take skin biopsies to look at the nerve fiber density and if gene and protein expression of relevant genes changes following paclitaxel treatment.
To measure if genetic variants in genes (e.g., CYP2C8*3, EPHA4/5, FGD4) are associated with more server PIPN symptoms.
| Before treatment start and during four cycles (one cycle equals 3 weeks) |
| Genes and NFL | To measure if genetic variants in genes (e.g., CYP2C8*3, EPHA4/5, FGD4) are associated with high NFL concentration in blood. | Before treatment start and during four cycles (one cycle equals 3 weeks) |
| Genes and Paclitaxel | To measure if genetic variants in genes (e.g., CYP2C8*3, EPHA4/5, FGD4) are associated with high paclitaxel concentration in blood. | Before treatment start and during four cycles (one cycle equals 3 weeks) |
| Drug-drug interactions | Investigate if and which specific drug-drug interactions are correlated to developing PIPN. | Before treatment start and during four cycles (one cycle equals 3 weeks) |
| Skin biopsies | Obtain skin biopsies from patients to elucidate which molecular mechanisms and phenotypes are associated with PIPN. | Before treatment start and during four cycles (one cycle equals 3 weeks) |
| IENFD | Obtain skin biopsies at baseline and at the beginning of cycle 3 or 4 (one cycle equals 3 weeks) to assess if the intraepidermal nerve fiber density (IENFD) changes during paclitaxel treatment. | Before treatment start and during four cycles (one cycle equals 3 weeks) |
| PHS | To assess whether the patients who have a sensation of heat during cooling of the skin (PHS) are also those who experience neuropathic pain. | Before treatment start and during four cycles (one cycle equals 3 weeks) |
| Nerve fiber dysfunction | To examine if increased NFL level is correlated to changes in small and large nerve fibers dysfunction. | Before treatment start and during four cycles (one cycle equals 3 weeks) |
| University Hospital of Southern Denmark, Sønderborg | Recruiting | Sønderborg | 6400 | Denmark |
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| University Hospital of Southern Denmark, Vejle | Recruiting | Vejle | 7100 | Denmark |
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