White_2020
Supportive Therapie · Version 2.1
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Referenz (Autor, Jahr, Journal) |
Studientyp Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum
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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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White
2020
BMJ Open Gastro |
randomised controlled trial
n = 50
UK |
cervical and bladder cancers undergoing radical chemoradiotherapy
20 fractions of external beam pelvic radiotherapy
Intervention (N = 24)
Age Mean (SD): 56.5 (13.9) Gender Female (%): 14 (58.3) Male (%): 10 (41.7)
Control (N = 26)
Age Mean (SD): 44.7 (14.4)
Gender Female (%): 22 (84.6) Male (%): 4 (15.4) |
N = 24 intervention group
individualised dietary counselling weekly throughout treatment
development of any LGI symptoms - symptomatic treatment
rapid-access investigation and treatment for any identified pathology: lactose intolerance, bacterial overgrowth or bile acid malabsorption |
N = 26 control group |
primary endpoint: severity of GI symptoms immediately post-treatment
secondary endpoints: treatment interruptions, enabled more patients to complete chemo-radiotherapy by reducing the severity of acute toxicity, QOL during and after treatment, frequency of late effects. |
Control vs. Intervention
median bowel symptoms score
intervention Baseline: N=24, Median 0.000 (0.000–0.300), N (%) of 0 scores: 13 (54.2) 6 Weeks: N= 22, Median 0.402 (0.000–0.667), N (%) of 0 scores: 8 (36.4) 12 Weeks: N= 23, Median 0.250 (0.000–0.625), N (%) of 0 scores: 6 (26.1) 52 Weeks: N= 20, Median 0.410 (0.000–1.243), N (%) of 0 scores: 7 (35.0) control Baseline: N= 26, Median 0.156 (0.000–0.333), N (%) of 0 scores: 11 (42.3) 6 Weeks: N= 23, Median 0.600 (0.250–1.286), N (%) of 0 scores: 1 (4.3) 12 Weeks: N= 25, Median 0.300 (0.000–0.700), N (%) of 0 scores: 7 (28.0) 52 Weeks: N= 20, Median 0.333 (0.000–0.838), N (%) of 0 scores: 6 (30.0) |
Control vs. Intervention
planned four cycles of chemotherapy
16 (62%)/26 vs. 17 (71%)/24
Chemotherapy regimens interrupted due to bowel symptoms: 3 vs. 1 pts
Radiotherapy Planned dose (Gy): 40.0 (35.6–52.5) vs. 42.6 (40.0–52.6) Delivered dose (Gy): 40.0 (35.6–52.8) vs. 42.6 (40.0–52.6)
Chemotherapy Planned cycles: 4 (4–4) vs. 4 (4–4) Delivered: cycles 4 (0–6) vs. 4 (1–4) Planned dose 280 (240–800) vs. 280 (240–800) Delivered dose: 280 (0–800) vs. 280 (70–800)
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This study was funded by the UK National Institute of Health Research’s Research for Patient Benefit Programme (reference PB-PG-0211-10024). |
2 10 withdrawals
"It was feasible to recruit to and deliver a randomised controlled trial of interventions in patients undergoing pelvic chemoradiotherapy. Lower median bowel scores were reported in the intervention group at 6 weeks, with fewer patients experiencing symptoms overall." |