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

Z

Zealand University Hospital

Status

Unknown

Conditions

Chemotherapy-induced Peripheral Neuropathy

Treatments

Other: QST and PRO measurements during treatment

Study type

Observational

Funder types

Other

Identifiers

NCT04167319
REG-088-2019

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

32 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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