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

NCT ID: NCT04167319

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-20

Study Completion Date

2021-09-30

Brief Summary

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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

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Conditions

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Chemotherapy-induced Peripheral Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Paclitaxel

Patients scheduled to receive paclitaxel as part of their standard treatment

QST and PRO measurements during treatment

Intervention Type OTHER

We will observe the natural course of CIPN using multiple measurements

Oxaliplatin

Patients scheduled to receive oxaliplatin as part of their standard treatment

QST and PRO measurements during treatment

Intervention Type OTHER

We will observe the natural course of CIPN using multiple measurements

Interventions

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QST and PRO measurements during treatment

We will observe the natural course of CIPN using multiple measurements

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Clinical Oncology and Palliative Care

Roskilde, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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REG-088-2019

Identifier Type: -

Identifier Source: org_study_id

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