A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)

Study Overview
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Brief Summary
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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.

Official Title
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A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)

Conditions
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Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Other: QST and PRO measurements during treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age A diagnosis of cancer. Fulfil the criteria for starting chemotherapy. Scheduled to undergo at least 4 courses of paclitaxel- or oxaliplatin-based chemotherapy. No prior paclitaxel, oxaliplatin or other neurotoxic chemotherapy. Exclusion Criteria: Unable to complete PRO measures. Previous neurotoxic chemotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paclitaxel<br>Patients scheduled to receive paclitaxel as part of their standard treatment | Other: QST and PRO measurements during treatment<br>* We will observe the natural course of CIPN using multiple measurements<br>|
| Oxaliplatin<br>Patients scheduled to receive oxaliplatin as part of their standard treatment | Other: QST and PRO measurements during treatment<br>* We will observe the natural course of CIPN using multiple measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIPN, QST, Chemotherapy-induced Peripheral Neuropathy, Neurotoxic Chemotherapy, oxaliplatin, paclitaxel, Tactilometry