Sasidharan_2019
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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Sasidharan
2019
Journal of Cancer Research and Therapeutics
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double‑blind, randomized clinical trial
single centre
N = 104
India
08/2011-04/2014 |
chemo-radiotherapy for carcinoma cervix
Resistant starch Median age (year): 50 (29-68) Median baseline weight (kg): 50 (34-92)
Digestible starch Median age (year): 48 (25-65) Median baseline weight (kg): 52.5 (35-75) |
N =50 30 gm of resistant starch 2x/d |
N=50 30 g of commercially available maize starch 2x/d |
primary endpoints: change in the proctitis score and diarrhea score
change of grade over time between the two groups
secondary outcomes: fecal SCFA concentration and microbial community abundance |
digestible starch group vs. resistant starch group
Clinical proctitis Baseline: 0 (0.0) vs. 0 (0) Week 2: 0 (0.0) vs. 4 (8.2) Week 3: 2 (4.2) vs. 3 (6.1) Week 4: 6 (12.2) vs. 7 (14.6) Week 5: 5 (10.2) vs. 7 (14.6) Week 6 :2 (4.1) vs. 3 (6.1) 6 weeks postintervention: 1 (2.0) vs. 1 (2.0)
Functional proctitis Baseline 0 (0.0) 0 (0.0) Week 2: 1 (2.0) vs. 2 (4.1) Week 3: 2 (4.1) vs. 1 (2.0) Week 4: 8 (16.3) vs. 5 (10.2) Week 5: 6 (12.2) vs. 2 (4.1) Week 6: 2 (4.1) vs. 0 (0.0) 6 weeks postintervention: 0 (0.0) vs. 0 (0.0)
Diarrhea Baseline: 3 (6.0) vs. 0 (0.0) Week 2: 7 (14.0) vs. 7 (14.0) Week 3: 8 (16.0) vs. 8 (16.0) Week 4: 7 (14.0) vs. 7 (14.0) Week 5: 1 (2.0) vs. 4 (8.0) Week 6: 0 (0.0) vs. 4 (8.0) 6 weeks postintervention: 0 (0.0) vs. 0 (0.0) |
short chain fatty acid concentrations were not significantly different in the groups at any point. |
Department of Biotechnology, Ministry of Science and Technology, Government of India supported this clinical trial. |
2 another starch in the control group microbiome analysis: no next‑generation sequencing 50% compliance in the cohort (collection of stool samples) primary endpoint not reached statement by the authors: "this could be considered as an overestimate or the incidence of toxicity could have been lower in both arms due to a daily intake of starch."
"The study did not demonstrate a significant benefit in administering resistant starch over and above normal diet to patients receiving pelvic radiotherapy. The reasons may be attributed to concurrent use of chemotherapy and decrease in intestinal probiotics. The use of digestible starch in the control arm may have contributed to lower incidence of the toxicity endpoints as well." |