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.
Study Type
OBSERVATIONAL
Enrollment
32
We will observe the natural course of CIPN using multiple measurements
Department of Clinical Oncology and Palliative Care
Roskilde, Denmark
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).
Time frame: 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).
Time frame: through study completion, an average of 1 year and 6 months
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.
Time frame: up to 5 days
Difference in VPT from baseline and during 1. course chemotherapy
Difference in the Vibrograms from baseline compared to 4 days after initiation of chemotherapy course no. 1.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: through study completion, an average of 1 year and 6 months
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