Involvement of SK3 Calcium Channel in Taxane Neuropathy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chemotherapy-induced Peripheral Neuropathy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology, Hospital, Chinon, Chinon, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Samples

Other

Blood samples before the introduction of chemotherapy

Primary outcomes

Appearance of a neuropathy secondary to taxanes using Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)

Time frame: From baseline and up to 4 months of follow-up
Evaluation of neuropathy will be performed using non-invasive test, gold standard, Cancer Institute Common Terminology Criteria for Adverse Events

Grading (from best to worst) :

0 = normal
- = slight paresthesia, mild weakness (subjective)
- = moderate paresthesia, moderate weakness (objective)
- = severe paresthesia with functional disability, severe weakness
- = paralysis
Appearance of a neuropathy secondary to taxanes using Total neuropathy score clinical (TNSc)

Time frame: From baseline and up to 4 months of follow-up

Evaluation of neuropathy will be performed using non-invasive test, Total neuropathy score clinical

Grading (from best to worst) :

Sensory symptoms : 0 = none (N), 1 = symptoms limited finger or toes, 2 = Symptoms extend to ankle or wrist, 3 = Symptoms extend to knee or elbow, 4 = Symptoms above knees or elbow or functionally disabling Motor symptoms : 0 = N, 1 = slight difficulty, 2 = moderate difficulty, 3 = require help/assistance, 4 = paralysis Autonomic symptoms : 0 = N, 1 , 2, 3, 4 (number of symptoms) Pin sensibility and vibration sensibility : 0 = normal (n), 1 = reduced in fingers/toes, 2 = reduced to wrist/ankle, 3 = reduced to elbow/knee, 4 = reduced to above elbow/knee Strength : 0 = n, 1 = mild weakness, 2 = moderate weakness, 3 = severe weakness, 4 = paralysis Deep tendon reflexe : 0 = n, 1 = ankle reflex reduced, 2 = ankle reflex absent, 3 = ankle reflex absent, other reduced, 4 = all reflexes absent

Secondary outcomes

Occurence of adverses events to taxanes (dysgeusia, myalgia, digestive toxicity tearing, onycholysis.)

Time frame: From baseline and up to 4 months of follow-up
Each adverse event will be evaluated using CTCAE score grading (from best to worst) :
- 0 : none
- 1 : minimal
- 2 : moderate
- 3 : severe
- 4 : very severe

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: NEUROTAX

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jan 25, 2019
Registry last updated: Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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