Chemotherapy-induced Peripheral NeuropathyCINCAN-1NCT04167319
A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- QST and PRO measurements during treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Nov 2019to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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.
Who cannot join
- Unable to complete PRO measures.
- Previous neurotoxic chemotherapy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Oncology and Palliative Care
Roskilde, 4000
About this study
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.
- Being tested
- QST and PRO measurements during treatment
- Keywords
- CIPN, QST, Chemotherapy-induced Peripheral Neuropathy, Neurotoxic Chemotherapy, oxaliplatin, paclitaxel, Tactilometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QST and PRO measurements during treatmentOther
We will observe the natural course of CIPN using multiple measurements
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel | Patients scheduled to receive paclitaxel as part of their standard treatment Receives: Other: QST and PRO measurements during treatment | |
| Oxaliplatin | Patients scheduled to receive oxaliplatin as part of their standard treatment Receives: Other: QST and PRO measurements during treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: through study completion, an average of 1 year and 6 months
Secondary outcomes (8)
Difference in PRO from baseline and during 1. course chemotherapy.
Difference in the NCCTG-CIPN Questionnaire from baseline compared to 4 days after initiation of chemotherapy course no. 1.
Measured: up to 5 days
Difference in VPT from baseline and during 1. course chemotherapy
Difference in the Vibrograms from baseline compared to 4 days after initiation of chemotherapy course no. 1.
Measured: up to 5 days
Difference in PRO from baseline to after chemotherapy course no. 3
For patients receiving paclitaxel: Difference in EORTC-QLQ-CIPN20 from baseline compared to after chemotherapy course no. 3.
Measured: through study completion, an average of 1 year and 6 months
Difference in PRO from baseline to after chemotherapy course no. 2
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.
Measured: through study completion, an average of 1 year and 6 months
Difference in VPT from baseline to af chemotherapy course no. 3
For patients receiving paclitaxel: Difference in the Vibrograms from baseline compared to after chemotherapy course no. 3.
Measured: through study completion, an average of 1 year and 6 months
Difference in VPT from baseline to af chemotherapy course no. 2
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.
Measured: through study completion, an average of 1 year and 6 months
No. of discontinuations
Number of patients not completing their planned courses of chemotherapy (reasons for discontinuation will be registered).
Measured: through study completion, an average of 1 year and 6 months
No. of dose reductions
Number of patients that need reductions of chemotherapy dose (reasons will be registered)
Measured: through study completion, an average of 1 year and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start20 Nov 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167319
- Sponsor's protocol ID
- REG-088-2019
- Acronym
- CINCAN-1
- Status last verified
- Sep 2020
- First submitted
- 7 Nov 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)
- ClinicalTrials.gov ID
- NCT04167319
- Acronym / sponsor ID
- CINCAN-1 / REG-088-2019
- Keywords
- CIPN, QST, Chemotherapy-induced Peripheral Neuropathy, Neurotoxic Chemotherapy, oxaliplatin, paclitaxel, Tactilometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel | – | Other: QST and PRO measurements during treatmentPatients scheduled to receive paclitaxel as part of their standard treatment |
| Oxaliplatin | – | Other: QST and PRO measurements during treatmentPatients scheduled to receive oxaliplatin as part of their standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- ≥ 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.
Key exclusion criteria (2 listed)
- Unable to complete PRO measures.
- Previous neurotoxic chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QST and PRO measurements during treatmentWe will observe the natural course of CIPN using multiple measurements | Other | Oxaliplatin, Paclitaxel |
Primary outcome
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).
8 secondary outcomes
Difference in PRO from baseline and during 1. course chemotherapy.
Time frame: up to 5 days
Difference in VPT from baseline and during 1. course chemotherapy
Time frame: up to 5 days
Difference in PRO from baseline to after chemotherapy course no. 3
Time frame: through study completion, an average of 1 year and 6 months
Difference in PRO from baseline to after chemotherapy course no. 2
Time frame: through study completion, an average of 1 year and 6 months
Difference in VPT from baseline to af chemotherapy course no. 3
Time frame: through study completion, an average of 1 year and 6 months
Difference in VPT from baseline to af chemotherapy course no. 2
Time frame: through study completion, an average of 1 year and 6 months
No. of discontinuations
Time frame: through study completion, an average of 1 year and 6 months
No. of dose reductions
Time frame: through study completion, an average of 1 year and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in VPT from baseline to 6 mo. (time frame: through study completion, an average of 1 year and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.