A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Zealand University Hospital
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Difference in VPT from baseline to 6 mo.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Difference in VPT from baseline to 6 mo.
Time Frame: 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.
Time Frame: 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 Outcomes
- Difference in PRO from baseline and during 1. course chemotherapy.(up to 5 days)
- Difference in VPT from baseline to af 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(through study completion, an average of 1 year and 6 months)
- No. of dose reductions(through study completion, an average of 1 year and 6 months)
- Difference in VPT from baseline and during 1. course chemotherapy(up to 5 days)
- Difference in PRO from baseline to after chemotherapy course no. 2(through study completion, an average of 1 year and 6 months)
- Difference in PRO from baseline to after chemotherapy course no. 3(through study completion, an average of 1 year and 6 months)
- No. of discontinuations(through study completion, an average of 1 year and 6 months)