Hua 2018
Supportive Therapie · Version 2.1
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Referenz (Autor, Jahr, Journal) |
Studientyp Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum |
Patienten-merkmale Indikation, Alter, Geschlecht (m/w) |
Intervention Fallzahl n, Beschreibung der präventiven bzw. therapeutischen Maßnahme Kontrolle Fallzahl n, Beschreibung der präventiven Maßnahme bzw. therapeutischen Maßnahme |
Zielgrößen Primärer Endpunkt Sekundäre(r) Endpunkt(e) |
Primärer Endpunkt Angaben für Intervention vs. Kontrolle Sekundäre(r) Endpunkt(e) Angaben für Intervention vs. Kontrolle |
Finanzierung |
Evidenzstufe Bei Abwertung: Angabe von Gründen Bewertung des Autors |
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Hua
2018
Supportive Care in Cancer
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prospective clinical trial
1 centre
N = 56
China
05/ 2015 – 01/2018 |
asopharyn- geal carcinoma (NPC) with chemoradiotherapy (CCRT)
100 mg/m2 cisplatin iv every 3 weeks concurrently with intensity-modulated radiation therapy.
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moderate pain group 4 ≤ NRS < 7: n = 27) severe pain group 7 ≤NRS ≤10 (n = 29)
oxycodone staring at 15 f(raction) an dose from 20 mg/d every 24h, if NRS ≤ 4, dose increase by 20mg/d, if not – stayed unchanged
for 3 wks or unacceptable sideeffects
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primary efficacy endpoint: total dose of CRO from baseline to the end of week 3. Secondary endpoints: were 1) 24-h pain effective rate (ER), remission rate weight loss change in QOL from baseline to week 3 question (question 101) on appetite CCRT response completely response (CR) |
Total dose of CRO was significantly higher in severe pain patients than in moderate pain patients (791.60 ± 332.449 mg vs. 587.27 ± 194.940 mg; P = 0.015). Moderate pain patients had significantly better quality of life (P = 0.037), lower weight loss (P = 0.030) and more active CCRT response (90.9% vs. 64.0%; P = 0.041).
Although 24-h pain control rate was comparable in the two groups (85.2% vs. 86.2%; P = 0.508), the moderate pain group score eventually stabilized at ~ 2 vs. 3 in the severe pain group (P < 0.001); the titration time to reach bearable pain (NRS ≤ 3) was also significantly shorter in moderate pain patients (2.45 ± 0.60 days vs. 3.60 ± 1.98 days; P = 0.012). Incidence of adverse events was comparable in both groups. |
This work was partly supported by the National Natural Science Foundation of China (No. 81772877, 81773103, 81572848), the Science and Technology Department of Guangdong Province, China (No. 2017A030310422). |
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"The study findings suggest that early introduction of low-dose CRO at the moderate pain stage could help reduce the total dose required, provide better pain control, improve quality of life, and enhance CCRT response." |