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
Christine Brunner
Kontakt:
Phone: +4351250481194
E-Mail: c.brunner@tirol-kliniken.at» Kontaktdaten anzeigen
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.
Inclusion Criteria:
- Patients with breast cancer or other gynecological tumors
- planned neoadjuvant, adjuvant or palliative chemotherapy
- </= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line)
- 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
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
- Active Comparator: Cryocompression
Patients in this group receive cryocompression for the hands. - Active Comparator: Cryotherapy
Patients in this group receive cryotherapy for the hands.
- Hilotherm Chemo Care:
Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.
Quelle: ClinicalTrials.gov
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