Involvement of SK3 Calcium Channel in Taxane Neuropathy (NEUROTAX)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Breast Cancer; Chemotherapy-induced Peripheral Neuropathy; Prostate Cancer

Treatments: Other: Blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT03816904

2018-A02884-51 (Other Identifier)

RIPH3-RNI18/NEUROTAX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

97 participants in 1 patient group

Breast or prostate cancer

Description:

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

Treatment:

Other: Blood samples