Zkouška AIUR: Chirurgické rukavice k prevenci periferní neuropatie (AIUR)
Randomizovaná kontrolovaná studie s použitím chirurgických rukavic k prevenci periferní neuropatie vyvolané chemoterapií pomocí paklitaxelu u pacientek s rakovinou prsu
This study aims to demonstrate the preventive effect of compression therapy using surgical gloves in chemotherapy-induced peripheral neuropathy. Patient-reported outcome measures (PROMs) are utilized for comparing the change in neuropathic pain between intervention and control groups. Among the PROMs, the neurotoxicity component of the functional Assessment of Cancer Therapy-taxane (FACT-Tax) is used for good and poor outcomes between baseline and post-chemotherapy in paclitaxel-treated breast cancer patients.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Chemotherapy-induced peripheral neuropathy (CIPN) is associated with side effects of taxanes, including paclitaxel. The common side effect may adversely affect the quality of life. However, no treatment for CIPN can be strongly recommended. Therefore, prevention is important. Cryotherapy, compression therapy, and exercise therapy can be considered for prevention, but no definitive recommendations are available. Studies with wider sample sizes are needed to confirm the efficacy and the preventive methods are complex for application. The study use surgical gloves for compression therapy to reduce discomfort and increase compliance with the procedure.
Patients with stage II-III breast cancer who receive paclitaxel chemotherapy for at least 12 weeks in six academic hospitals in South Korea will participate in the study. The study design is a multicenter, open-label, randomized controlled trial. The patients are randomly assigned to intervention or control groups. Intervention patients will wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion. The primary outcome is to demonstrate the preventive effect of compression therapy using surgical gloves as measured by the change in the neurotoxicity of FACT-Tax questionnaire.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Bupyeong
-
Incheon, Bupyeong, Jižní Korea, 21431
- Incheon St. Mary's Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age greater or equal to 19 years, under 70 years old
- Stage II-III breast cancer
- No distant metastasis
- Patient scheduled to be receiving adjuvant or neoadjuvant paclitaxel for at least 12 weeks
- Signed informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%)
Exclusion Criteria:
- Recurred breast cancer
- Patients who have previously received treatment that could cause neuropathy; taxane or platinum-based chemotherapy, antitubulins, proteasome inhibitors
- Known history of neuropathy
- Chronic kidney disease
- Raynaud's phenomenon
- Peripheral vascular disease; peripheral arterial ischemia
- Cold intolerance
- Allergy in natural rubber latex or surgical gloves
- Patients who have dermatitis, wound, or musculoskeletal problems in hand at enrollment
- Current use medications which may mitigate chemotherapy-induced peripheral neuropathy; duloxetine, gabapentin/pregabalin, Baclofen-amitriptyline-ketamine (BAK; topical amitriptyline, ketamine, ±baclofen), oral cannabinoids, tricyclic antidepressants, ganglioside-monosialic acid
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Compression therapy using surgical gloves
Study participants wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion |
Intervention group wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion |
|
Žádný zásah: Control
No intervention is provided on both hands. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale
Časové okno: Before starting paclitaxel course (baseline), and 1~2 weeks from finishing paclitaxel course chemotherapy (target)
|
The change in FACT-NTX will be divided into a good outcome (change in FACT-NTX less than five from baseline to target timeframe) versus a poor outcome (change in FACT NTX greater than or equal to five from baseline to target timeframe). The difference in the number of poor outcome participants will compare between the two groups. The FACT-NTX is 5-point Likert-type scale. Each item measures on a 0-4 scale (0, not at all; 4, very much). A greater change in the FACT-NTX score was considered a clinically meaningful increase in CIPN. |
Before starting paclitaxel course (baseline), and 1~2 weeks from finishing paclitaxel course chemotherapy (target)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in 16 items component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) Therapy subscale
Časové okno: Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
|
The score changes in 16 items (neurotoxicity and taxane) component of the FACT-Taxane scale will be compared between the two groups. The FACT-Taxane is 5-point Likert-type scale. Each item measures on a 0-4 scale (0, not at all; 4, very much). A scale of 0 indicates a better outcome, and 4 indicates a worse outcome. |
Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
|
|
Changes in 27 items component of the Functional Assessment of Cancer Therapy-General (FACT-G) scale
Časové okno: Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
|
The score changes in general 27 items component of the FACT-G scale will be compared between the two groups. The FACT-G consists of four well-being subscales; physical well-being (7-item), social/family well-being (7-item), emotional well-being (6-item), and functional well-being (7-item). The FACT-G is 5-point Likert-type scale (0, not at all; 4, very much). For physical and emotional well-being, the higher the sum of scores, the lower the quality of life; for social/family and functional well-being, the higher the sum of scores, the higher the quality of life. |
Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
|
|
Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale at additional periods.
Časové okno: During paclitaxel course (about 1.5 months after starting) and six months after finishing paclitaxel course
|
The change in FACT-NTX will be divided into a good outcome (change in FACT-NTX less than five from baseline to target timeframe) versus a poor outcome (change in FACT NTX greater than or equal to five from baseline to target timeframe). The difference in the number of poor outcome participants will compare between the two groups. The FACT-NTX is 5-point Likert-type scale. Each item measures on a 0-4 scale (0, not at all; 4, very much). A greater change in the FACT-NTX score was considered a clinically meaningful increase in CIPN. |
During paclitaxel course (about 1.5 months after starting) and six months after finishing paclitaxel course
|
|
FACT-NTX 11-item total score (continuous)
Časové okno: Baseline, during chemotherapy (mid-cycle), 1-2 weeks after completion of paclitaxel, and 6 months after completion
|
Mean FACT-NTX 11-item total score at each time point and change from baseline, analyzed using mixed-effects model for repeated measures (MMRM). Higher scores indicate greater neurotoxicity (range 0-44). |
Baseline, during chemotherapy (mid-cycle), 1-2 weeks after completion of paclitaxel, and 6 months after completion
|
|
Change in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) for CIPN
Časové okno: Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
|
NCI-CTCAE for CIPN is a method for reporting adverse event severity by a combination of clinical evaluation. The adverse effects of CIPN to be investigated are peripheral motor, sensory neuropathy, dysesthesia, paresthesia, neuralgia, and skin/nail toxicity. |
Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
|
|
Comfort with intervention scale score
Časové okno: during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
|
Comfort with the intervention (two-layer of surgical gloves) will be assessed on 4-point scale. The points are classified 0=dissatisfied; 1=not satisfied; 2=satisfied; 3=very satisfied. |
during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Hand-specific sub-score
Časové okno: Baseline, during chemotherapy, 1-2 weeks after completion, 6 months after completion
|
FACT-NTX hand-specific sub-score (4 items: numbness/tingling in hands, discomfort in hands, trouble buttoning buttons, difficulty feeling shape of small objects; 0-16). The intervention directly targets the upper extremities; this sub-score is expected to capture the primary treatment effect. |
Baseline, during chemotherapy, 1-2 weeks after completion, 6 months after completion
|
|
Foot-specific sub-score
Časové okno: Baseline, during chemotherapy, 1-2 weeks after completion, 6 months after completion
|
FACT-NTX foot-specific sub-score (numbness/tingling in feet, discomfort in feet, trouble walking; 0-12). Internal control to assess body-region specificity of intervention effect |
Baseline, during chemotherapy, 1-2 weeks after completion, 6 months after completion
|
|
Subgroup analysis
Časové okno: 1-2 weeks after completion of paclitaxel
|
Subgroup analysis by paclitaxel schedule (weekly 80 mg/m² × 12 vs 3-weekly 175 mg/m² × 4): primary and secondary outcomes |
1-2 weeks after completion of paclitaxel
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- AIUR trial
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .