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Trial record 1 of 1 for:    NCT04167319
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A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO) (CINCAN-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04167319
Recruitment Status : Active, not recruiting
First Posted : November 18, 2019
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Zealand University Hospital

Tracking Information
First Submitted Date November 7, 2019
First Posted Date November 18, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date November 20, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2019)
  • 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).
  • 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).
Original Primary Outcome Measures
 (submitted: November 14, 2019)
  • Co-primary outcome for paclitaxel [ 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).
  • Co-primary outcome for oxaliplatin [ 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).
Change History
Current Secondary Outcome Measures
 (submitted: March 14, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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)
Original Secondary Outcome Measures
 (submitted: November 14, 2019)
  • PRO-Outcome Acute [ Time Frame: up to 5 days ]
    Difference in the EORTC-QLQ-CIPN20 from baseline compared to 4 days after initiation of chemotherapy course no. 1.
  • QST-Outcome Acute [ Time Frame: up to 5 days ]
    Difference in the Vibrograms from baseline compared to 4 days after initiation of chemotherapy course no. 1.
  • Paclitaxel specific Outcome 1 [ 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.
  • Oxaliplatin specific Outcome 1 [ 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.
  • Paclitaxel specific Outcome 2 [ 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.
  • Oxaliplatin specific Outcome 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.
  • 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).
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition Chemotherapy-induced Peripheral Neuropathy
Intervention Other: QST and PRO measurements during treatment
We will observe the natural course of CIPN using multiple measurements
Study Groups/Cohorts
  • Paclitaxel
    Patients scheduled to receive paclitaxel as part of their standard treatment
    Intervention: Other: QST and PRO measurements during treatment
  • Oxaliplatin
    Patients scheduled to receive oxaliplatin as part of their standard treatment
    Intervention: Other: QST and PRO measurements during treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 1, 2020)
32
Original Estimated Enrollment
 (submitted: November 14, 2019)
30
Estimated Study Completion Date September 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT04167319
Other Study ID Numbers REG-088-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zealand University Hospital
Study Sponsor Zealand University Hospital
Collaborators Odense University Hospital
Investigators Not Provided
PRS Account Zealand University Hospital
Verification Date September 2020