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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

— CINCAN-1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04167319
• Other study ID #: REG-088-2019
• Status: Active, not recruiting
• Start date: November 20, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2020
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• QST and PRO measurements during treatment
We will observe the natural course of CIPN using multiple measurements

Locations

Country	Name	City	State
Denmark	Department of Clinical Oncology and Palliative Care	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
Zealand University Hospital	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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