Chemotherapy-induced Peripheral Neuropathy
Conditions
Keywords
CIPN, QST, Chemotherapy-induced Peripheral Neuropathy, Neurotoxic Chemotherapy, oxaliplatin, paclitaxel, Tactilometry
Brief summary
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.
Interventions
OTHERQST and PRO measurements during treatment
We will observe the natural course of CIPN using multiple measurements
Sponsors
Odense University Hospital
Zealand University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in VPT from baseline to 6 mo. | through study completion, an average of 1 year and 6 months | 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). |
| Difference in VPT from Baseline to 4 mo. | through study completion, an average of 1 year and 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in PRO from baseline to after chemotherapy course no. 3 | through study completion, an average of 1 year and 6 months | For patients receiving paclitaxel: Difference in EORTC-QLQ-CIPN20 from baseline compared to after chemotherapy course no. 3. |
| Difference in PRO from baseline to after chemotherapy course no. 2 | through study completion, an average of 1 year and 6 months | 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. |
| Difference in VPT from baseline to af chemotherapy course no. 3 | through study completion, an average of 1 year and 6 months | For patients receiving paclitaxel: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 3. |
| Difference in PRO from baseline and during 1. course chemotherapy. | up to 5 days | Difference in the NCCTG-CIPN Questionnaire from baseline compared to 4 days after initiation of chemotherapy course no. 1. |
| No. of discontinuations | through study completion, an average of 1 year and 6 months | Number of patients not completing their planned courses of chemotherapy (reasons for discontinuation will be registered). |
| No. of dose reductions | through study completion, an average of 1 year and 6 months | Number of patients that need reductions of chemotherapy dose (reasons will be registered) |
| Difference in VPT from baseline to af chemotherapy course no. 2 | through study completion, an average of 1 year and 6 months | 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. |
| Difference in VPT from baseline and during 1. course chemotherapy | up to 5 days | Difference in the Vibrograms from baseline compared to 4 days after initiation of chemotherapy course no. 1. |
Countries
Denmark
Outcome results
None listed