Involvement of SK3 Calcium Channel in Taxane Neuropathy

NCT03816904 | Completed

• 2 other identifiers: RIPH3-RNI18/NEUROTAX2018-A02884-51
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Chemotherapy-induced Peripheral Neuropathy; Prostate Cancer

Outcome Measures

Primary Outcomes (2)

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

  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 1. = slight paresthesia, mild weakness (subjective) 2. = moderate paresthesia, moderate weakness (objective) 3. = severe paresthesia with functional disability, severe weakness 4. = paralysis

  From baseline and up to 4 months of follow-up

• Appearance of a neuropathy secondary to taxanes using Total neuropathy score clinical (TNSc)

  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

  From baseline and up to 4 months of follow-up

Secondary Outcomes (1)

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

  From baseline and up to 4 months of follow-up

Study Arms (1)

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

Other: Blood samples

Interventions

Blood samples OTHER

Blood samples before the introduction of chemotherapy

Breast or prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (2)

Department of Oncology, Hospital, Chinon

Chinon, 37500, France

Location

Department of Medical Oncology, University Hospital, Tours

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

assay number of CAG triplets composing the KCNN3 gene usual blood sample

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Catherine BARBE, MD

  University Hospital, Tours

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 25, 2019
• Study Start: February 6, 2019
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

FR (2)