A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO) (CINCAN-1)

September 1, 2020 updated by: Zealand University Hospital

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Department of Clinical Oncology and Palliative Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will invite patients to participate in conjuction with their standard treatment. Patients have been diagnosed with ovarian cancer or colorectal cancer and have been scheduled to adjuvant treatment or metastatic treatment with one of the applicable drugs.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Paclitaxel
Patients scheduled to receive paclitaxel as part of their standard treatment
Other: QST and PRO measurements during treatment
We will observe the natural course of CIPN using multiple measurements
Oxaliplatin
Patients scheduled to receive oxaliplatin as part of their standard treatment
Other: QST and PRO measurements during treatment
We will observe the natural course of CIPN using multiple measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through study completion, an average of 1 year and 6 months
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).
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.
Time Frame: up to 5 days
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
Time Frame: up to 5 days
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
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in PRO from baseline to after chemotherapy course no. 2
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in VPT from baseline to af chemotherapy course no. 3
Time Frame: 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.
through study completion, an average of 1 year and 6 months
Difference in VPT from baseline to af chemotherapy course no. 2
Time Frame: 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.
through study completion, an average of 1 year and 6 months
No. of discontinuations
Time Frame: 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).
through study completion, an average of 1 year and 6 months
No. of dose reductions
Time Frame: through study completion, an average of 1 year and 6 months
Number of patients that need reductions of chemotherapy dose (reasons will be registered)
through study completion, an average of 1 year and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2019

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-088-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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