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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04167319
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Zealand University Hospital

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.


Condition or disease Intervention/treatment
Chemotherapy-induced Peripheral Neuropathy Other: QST and PRO measurements during treatment

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Paclitaxel
Patients scheduled to receive paclitaxel as part of their standard treatment
Other: QST and PRO measurements during treatment
We will observe the natural course of CIPN using multiple measurements

Oxaliplatin
Patients scheduled to receive oxaliplatin as part of their standard treatment
Other: QST and PRO measurements during treatment
We will observe the natural course of CIPN using multiple measurements




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. Difference in PRO from baseline and during 1. course chemotherapy. [ 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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)


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04167319


Contacts
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Contact: Sebastian Nielsen, MD +4526714558 sewn@regionsjaelland.dk

Sponsors and Collaborators
Zealand University Hospital
Odense University Hospital

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT04167319    
Other Study ID Numbers: REG-088-2019
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
CIPN
QST
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Oxaliplatin
Antineoplastic Agents