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

• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Interventions: Other: QST and PRO measurements during treatment

• Registration Number: NCT04167319
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Study Start: 2019-11-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oxaliplatin	QST and PRO measurements during treatment	Patients scheduled to receive oxaliplatin as part of their standard treatment
Paclitaxel	QST and PRO measurements during treatment	Patients scheduled to receive paclitaxel as part of their standard treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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.
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 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.
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 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.
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).

Trial Locations

Locations (1)

Department of Clinical Oncology and Palliative Care; 🇩🇰 Roskilde, Denmark