Involvement of SK3 Calcium Channel in Taxane Neuropathy

NCT ID: NCT03816904

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-06

Study Completion Date

2020-06-12

Brief Summary

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Taxane neuropathy is a common and long-term side effect of long-term morbidity in patients surviving cancer. No preventive or symptomatic treatment has been shown to be effective. Its pathophysiology is poorly known and probably multifactorial. A possible mechanism would be mediated by the activation of the SK3 calcium channel: a retrospective study carried out at the University Hospital of Tours (Carina RUA) found a significant association between the number of CAG triplets in the KCNN3 gene coding for the SK3 channel and the appearance of a taxane neuropathy.

Detailed Description

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Patients hospitalized in medical oncology day hospital at the University Hospital of Tours or CHC oncology day hospital, for their chemotherapy with taxanes (paclitaxel or docetaxel) for breast or prostate cancer, will be offered the study.

The mode of administration of chemotherapy and the usual follow-up will not be modified by the protocol The determination of the SK3 status will be made from an additional tube collected during a collection as part of the treatment at the first arrival in a day hospital (no more blood tests). Blood sample of 7mL. Shipments and analyzes of samples in Tours in the pharmacogenetics laboratory under the responsibility of Dr. BARIN-LE GUELLEC.

This study is non-invasive, without impact on the therapeutic management. The result of the polymorphism of SK3 will not be indicated in the record, so as not to influence the follow-up of the treatment and to allow an evaluation of the occurrence of peripheral neuropathy in blindness of the number of repetitions of the CAG triplet of the KCNN3 gene.

Conditions

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Breast Cancer Chemotherapy-induced Peripheral Neuropathy Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast or prostate cancer

Taken blood samples on patients hospitalized in medical oncology day hospital at the University Hospital of Tours or CHC oncology day hospital, for their chemotherapy with taxanes (paclitaxel or docetaxel) for breast or prostate cancer

Blood samples

Intervention Type OTHER

Blood samples before the introduction of chemotherapy

Interventions

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Blood samples

Blood samples before the introduction of chemotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Breast Group

* Age ≥ 18 years
* Breast cancer
* Chemotherapy with paclitaxel or docetaxel
* Adjuvant or neoadjuvant chemotherapy in localized cancer or first-line treatment in metastatic cancer
* Signed informed consent

Prostate Group

* Age ≥ 18 years
* Metastatic prostate cancer
* Chemotherapy with docetaxel in 1st line
* Signed informed consent

Exclusion Criteria

* Anteriority or concomitance of another chemotherapy provider of neuropathy (platinum salts)
* Another possible cause of neuropathy: diabetes, alcoholism, vitamin B9 / B12 deficiency, neurodegenerative disease, Raynaud's syndrome
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine BARBE, MD

Role: STUDY_DIRECTOR

University Hospital, Tours

Locations

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Department of Oncology, Hospital, Chinon

Chinon, , France

Site Status

Department of Medical Oncology, University Hospital, Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2018-A02884-51

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH3-RNI18/NEUROTAX

Identifier Type: -

Identifier Source: org_study_id

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