Clinical trial NCT04167319: A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)
Official title: A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: CIPN
QST
Chemotherapy-induced Peripheral Neuropathy
Neurotoxic Chemotherapy
oxaliplatin
paclitaxel
Tactilometry
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2019-11-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in VPT from baseline to 6 mo.
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in VPT from Baseline to 4 mo.
timeFrame: through study completion, an average of 1 year and 6 months
Secondary outcomes:
measure: Difference in PRO from baseline and during 1. course chemotherapy.
timeFrame: up to 5 days
measure: Difference in VPT from baseline and during 1. course chemotherapy
timeFrame: up to 5 days
measure: Difference in PRO from baseline to after chemotherapy course no. 3
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in PRO from baseline to after chemotherapy course no. 2
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in VPT from baseline to af chemotherapy course no. 3
timeFrame: through study completion, an average of 1 year and 6 months
measure: Difference in VPT from baseline to af chemotherapy course no. 2
timeFrame: through study completion, an average of 1 year and 6 months
measure: No. of discontinuations
timeFrame: through study completion, an average of 1 year and 6 months
measure: No. of dose reductions
timeFrame: through study completion, an average of 1 year and 6 months
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Department of Clinical Oncology and Palliative Care
Study officials:
References: