Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502139-20-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| Independent Research Fund Denmark | INDUSTRY |
Not provided
Not provided
Not provided
The primary objective of this clinical trial is to ievaluate the effect of semaglutide (GLP-1 receptor agonist) in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) haematopoietic stem cell transplantation (HSCT). The secondary objective is to evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT.
Study design:
The study is designed as a randomized, double-blind, placebo-controlled, phase 2, two-centre investigator-initiated clinical study.
Patients referred for treatment with high-dose chemotherapy and auto-HSCT will be randomized in a 1:1 manner to receive either semaglutide or placebo. The study includes a run-in period 3 to 4-week low-dose period with semaglutide subcutaneously (s.c.) 0.25 mg once-weekly (QW) prior to high-dose chemotherapy treatment followed by a period of 4 to 5 weeks with semaglutide 0.5 mg QW. Total duration of treatment with investigational drug will be 8 weeks. Total study duration for the individual patients will be 20-22 weeks, including a 2-4-week screening period and 10 weeks of follow-up.
Study population:
A planned total number of 40 patients will be randomized.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Active Comparator | Semaglutide active drug 0.25-0.5mg, once-weekly, injection |
|
| Placebo | Placebo Comparator | Semaglutide placebo, once-weekly, injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide Pen Injector [Ozempic] | Drug | Semaglutide active drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| gastrointestinal mucositis severity | mean severity grade (0-II) | from day of stem cell infusion (day 0) to week +3 |
| Measure | Description | Time Frame |
|---|---|---|
| CRP increment | AUC | from day of stem cell infusion (day 0) to week +3 |
| Quality of life general | evaluated by EORTC QLQ-C30 questionnaire. The QLQ-C30 summary score is calculated as the mean of the combined 13 QLQ-C30 scale and item scores (excluding global QoL and financial impact). Final scoring range: 0-100 with a higher score indicating a better quality of life |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Ebbesen Sørum, MD, PhD | Contact | 004540638545 | maria.ebbesen.soerum@regionh.dk | |
| Klaus Müller, DMSc | Contact | 004525325559 | klaus.mueller@regionh.dk |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39384243 | Derived | Sorum ME, Gang AO, Tholstrup DM, Gudbrandsdottir S, Kissow H, Kornblit B, Muller K, Knop FK. Semaglutide treatment for PRevention Of Toxicity in high-dosE Chemotherapy with autologous haematopoietic stem-cell Transplantation (PROTECT): study protocol for a randomised, double-blind, placebo-controlled, investigator-initiated study. BMJ Open. 2024 Oct 9;14(10):e089862. doi: 10.1136/bmjopen-2024-089862. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided
randomized 1:1
Not provided
Not provided
Not provided
| Placebo |
| Drug |
semaglutide placebo |
|
| change from baseline (start of high-dose chemotherapy) to study week 9 and 18 |
| Quality of life - high-dose chemotherapy treatment specific | evaluated by EORTC QLQ-HDC29 questionnaire. The QLQ HDC29 module includes 29 items, consisting of 6 multi-item scales and 8 singleitems. Final scoring range: 0-100 with a higher score indicating a better quality of life | change from baseline (start of high-dose chemotherapy) to study week 9 and 18 |
| Safety profile evaluated by number of SARs | SAR will be estimated according to ICH-GCP guidelines | Start of study drug treatment (week 1) until study week 10 |