Clinical trial NCT03816904: Involvement of SK3 Calcium Channel in Taxane Neuropathy
Official title: Involvement of SK3 Calcium Channel in Taxane Neuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Chemotherapy-induced Peripheral Neuropathy
Prostate Cancer
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in oncology day hospital for their chemotherapy with taxanes (paclitaxel or docetaxel) for breast or prostate cancer, will be offered the study.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Appearance of a neuropathy secondary to taxanes using Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: From baseline and up to 4 months of follow-up
measure: Appearance of a neuropathy secondary to taxanes using Total neuropathy score clinical (TNSc)
timeFrame: From baseline and up to 4 months of follow-up
Secondary outcomes:
measure: Occurence of adverses events to taxanes (dysgeusia, myalgia, digestive toxicity tearing, onycholysis.)
timeFrame: From baseline and up to 4 months of follow-up
Other outcomes:
Locations:
city: Chinon
country: France
facility: Department of Oncology, Hospital, Chinon
city: Tours
country: France
facility: Department of Medical Oncology, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Catherine BARBE, MD
role: STUDY_DIRECTOR
References: