Mucositis and systemical inflammation, which is a treatment-related complication after treatment with high-dose chemotherapy
Conditions
Brief summary
GI mucositis severity: mean severity grade (0-II) from study week 5 to 9
Detailed description
CRP increment in the early post-transplant phase: area under the plasma concentration-time curve (AUC) from study week 5 to 8, Quality of life (QOL): change from baseline (study week 4) to study week 9 and 18 evaluated by EORTC QLQ-C30 and EORTC QLQ-HDC29 questionnaires, Safety profile: evaluated by SAR according to ICH-GCP guidelines
Interventions
DRUGSemaglutide placebo (saline)
DRUGRoute of administration: Subcutaneous injection
DRUG1.5 ml pre-filled pen-injector
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GI mucositis severity: mean severity grade (0-II) from study week 5 to 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| CRP increment in the early post-transplant phase: area under the plasma concentration-time curve (AUC) from study week 5 to 8, Quality of life (QOL): change from baseline (study week 4) to study week 9 and 18 evaluated by EORTC QLQ-C30 and EORTC QLQ-HDC29 questionnaires, Safety profile: evaluated by SAR according to ICH-GCP guidelines | — |
Countries
Denmark
Outcome results
None listed