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JOURNAL ONKOLOGIE – STUDIE

Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy

Rekrutierend

NCT-Nummer:
NCT04632797

Studienbeginn:
Februar 2020

Letztes Update:
17.11.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Peripheral Nervous System Diseases

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University Innsbruck

Collaborator:
-

Studienleiter

Christine Brunner
Principal Investigator
Medical University Innsbruck

Kontakt

Studienlocations (1 von 1)

Medical University Innsbruck
6020 Innsbruck
AustriaRekrutierend» Google-Maps

Studien-Informationen

Detailed Description:

In this randomized, observer blinded, monocentric study 196 patients will be included in a

four years period.

The patients will be 1 to 1 randomized in either cryocompression or cryotherapy. Patients who

are not eligible for either cryocompression or cryotherapy will be included in the control

group.

Additionally every patient (excluding the control group) receives cryotherapy for the feet.

Before receiving the first chemotherapy CTCAE, Semmes-Weinstein monofilament examination

(SWME), vibration test for hand and feet, and nerve conduction velocity (NCV) only for hands.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients with breast cancer or other gynecological tumors

- planned neoadjuvant, adjuvant or palliative chemotherapy

-
- at least three cycles of chemotherapy with taxanes

- written consent

- 18 years and older

Exclusion Criteria:

- PNP >/= 2

- neuralgia

- metastases in bones, metastases in soft tissue (located in skin, hands or feet)

- Raynaud syndrome

- peripheral arterial ischemia

- hand-feet syndrome

Studien-Rationale

Primary outcome:

1. NCV (nerve conduction velocity) (Time Frame - 4 years):
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°

2. CTCAE 4.03 (Time Frame - 4 years):
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°

3. SWME (Semmes Weinstein monofilament examination) (Time Frame - 4 years):
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°

4. tuning-fork-test (Time Frame - 4 years):
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°

5. EORTC QoLCIPN20 (Time Frame - 4 years):
Patient-reported outcomes (PRO)

6. Neuro-QoL Domain for Upper Extremity (FineMotor, ADL) (Time Frame - 4 years):
Patient-reported outcomes (PRO)

Secondary outcome:

1. National Cancer Institute Common Toxicity Criteria version 2 (Time Frame - 4 years):
Changes of nails

2. time frame until polyneuopathy occurs (Time Frame - 4 years):
time frame until polyneuopathy occurs whilst receiving Taxanes

Studien-Arme

  • Active Comparator: Cryocompression
    Patients in this group receive cryocompression for the hands.
  • Active Comparator: Cryotherapy
    Patients in this group receive cryotherapy for the hands.

Geprüfte Regime

  • Hilotherm Chemo Care:
    Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.

Quelle: ClinicalTrials.gov


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