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

NCT04167319 | Unknown

• 1 other identifier: REG-088-2019
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

CIPN; QST; Chemotherapy-induced Peripheral Neuropathy; Neurotoxic Chemotherapy; oxaliplatin; paclitaxel; Tactilometry

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Difference in PRO from baseline and during 1. course chemotherapy.

  up to 5 days

• Difference in VPT from baseline and during 1. course chemotherapy

  up to 5 days

• Difference in PRO from baseline 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

  through study completion, an average of 1 year and 6 months

• Difference in VPT from baseline to af chemotherapy course no. 3

  through study completion, an average of 1 year and 6 months

Study Arms (2)

Paclitaxel

Patients scheduled to receive paclitaxel as part of their standard treatment

Other: QST and PRO measurements during treatment

Oxaliplatin

Patients scheduled to receive oxaliplatin as part of their standard treatment

Other: QST and PRO measurements during treatment

Interventions

QST and PRO measurements during treatment OTHER

We will observe the natural course of CIPN using multiple measurements

Oxaliplatin; Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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.

You may not qualify if:

• Unable to complete PRO measures.
• Previous neurotoxic chemotherapy.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Odense University Hospital: collaborator

Study Sites (1)

Department of Clinical Oncology and Palliative Care

Roskilde, 4000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected at baseline and after 3 courses of chemotherapy. Will be used for whole genome sequencing and specific findings will be correlated to CIPN QST Measurements.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 18, 2019
• Study Start: November 20, 2019
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)