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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
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Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to discontinuation or omission of antineoplastic drugs, possibly affecting efficacy of cancer treatment. There is a lack of knowledge about the natural course of CIPN and to this date, there are no available methods for the early detection of CIPN. With no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.
This study will investigate the natural course of paclitaxel- and oxaliplatin induced peripheral neuropathy using novel diagnostic techniques. Multi-frequency vibrational technology has provided an objective method for the early detection of diabetic neuropathy. Our study will test the feasibility of this method within the field of clinical oncology and CIPN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel | Patients scheduled to receive paclitaxel as part of their standard treatment |
| |
| Oxaliplatin | Patients scheduled to receive oxaliplatin as part of their standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QST and PRO measurements during treatment | Other | We will observe the natural course of CIPN using multiple measurements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in VPT from baseline to 6 mo. | For patients receiving paclitaxel: Difference in vibrograms from baseline compared to vibrograms after the end of the 6th course of chemotherapy or the last course of chemotherapy (if before course no. 6). | through study completion, an average of 1 year and 6 months |
| Difference in VPT from Baseline to 4 mo. | For patients receiving oxaliplatin: Difference in vibrograms from baseline compared to vibrograms after the end of the 4th course of chemotherapy or the last course of chemotherapy (if before course no. 4). | through study completion, an average of 1 year and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in PRO from baseline and during 1. course chemotherapy. | Difference in the NCCTG-CIPN Questionnaire from baseline compared to 4 days after initiation of chemotherapy course no. 1. | up to 5 days |
| Difference in VPT from baseline and during 1. course chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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We will invite patients to participate in conjuction with their standard treatment. Patients have been diagnosed with ovarian cancer or colorectal cancer and have been scheduled to adjuvant treatment or metastatic treatment with one of the applicable drugs.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology and Palliative Care | Roskilde | 4000 | Denmark |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 28, 2022 | |
| Reset | Oct 3, 2022 |
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Blood samples collected at baseline and after 3 courses of chemotherapy. Will be used for whole genome sequencing and specific findings will be correlated to CIPN QST Measurements.
Difference in the Vibrograms from baseline compared to 4 days after initiation of chemotherapy course no. 1. |
| up to 5 days |
| Difference in PRO from baseline to after chemotherapy course no. 3 | For patients receiving paclitaxel: Difference in EORTC-QLQ-CIPN20 from baseline compared to after chemotherapy course no. 3. | through study completion, an average of 1 year and 6 months |
| Difference in PRO from baseline to after chemotherapy course no. 2 | For patients receiving oxaliplatin: Difference in EORTC-QLQ-CIPN20 from baseline compared to after chemotherapy course no. 2. Some patients receiving oxaliplatin will have 6 courses of planned chemotherapy or planned metastatic treatment, in this case comparison will be made after chemotherapy course no. 3. | through study completion, an average of 1 year and 6 months |
| Difference in VPT from baseline to af chemotherapy course no. 3 | For patients receiving paclitaxel: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 3. | through study completion, an average of 1 year and 6 months |
| Difference in VPT from baseline to af chemotherapy course no. 2 | For patients receiving oxaliplatin: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 2. Some patients receiving oxaliplatin will have 6 courses of planned chemotherapy or planned metastatic treatment, in this case comparison will be made after chemotherapy course no. 3. | through study completion, an average of 1 year and 6 months |
| No. of discontinuations | Number of patients not completing their planned courses of chemotherapy (reasons for discontinuation will be registered). | through study completion, an average of 1 year and 6 months |
| No. of dose reductions | Number of patients that need reductions of chemotherapy dose (reasons will be registered) | through study completion, an average of 1 year and 6 months |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 28, 2022 | Oct 3, 2022 |