Empower the Heart of Patients with Terminal Cancer using Cardiac Medicines Trial

Phase 1

Conditions: Patients with terminal cancer in palliative care
MedDRA version: 20.0Level: PTClassification code 10059513Term: Palliative careSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2021-006994-48-DE

Lead Sponsor: niversitätsklinikum Essen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 72

Inclusion Criteria

1. Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject.
2. Age = 18 years
3. Male or female subject with solid cancer in UICC stage 4 (in palliative care).
4. Three-six months expected survival (minimum 1 month) as assessed according to local standards.
5. Patients under optimised pain management.
6. Patients must be able to swallow tablets.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

1. Previous participation in this trial. Participation is defined as randomised.
2. Ongoing haemodialysis
3. Patients currently on intravenous iron
4. Acute sepsis with at least 2 points at the quick sequential organ failure assessment (qSOFA) score. The use of i.v.-antibiotics is permitted in patients with a lower qSOFA score.
5.Ongoing acute exacerbation of chronic obstructive pulmonary disease (COPD)
6. Acute ST elevation myocardial infarction (STEMI) or severe pulmonary embolism (PE) or severe deep vein thrombosis (DVT) (currently or in last 4 weeks)
7. Current uncontrolled cerebral metastasis
8. Impaired neurological status, precluding the ability to walk
9. Unable or unwilling to give written informed consent
10. Participation in other interventional trials using investigational products in randomised settings within the last 30 days

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To improve the self-care ability and self-reported health care status of patients with terminal cancer in palliative care.;Secondary Objective: To improve disease-specific measures of quality of life, symptom status and functional capacity of patients with terminal cancer in palliative care;Primary end point(s): Days alive and able to wash themselves;Timepoint(s) of evaluation of this end point: Baseline and at end of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Days alive and able to wash themselves since baseline <br>• PGA of well-being on days 10, 20 and 30 vs baseline <br>• 4m-walking speed on days 10, 20 and 30 <br>• Change in Eastern Co-operative Oncology Group (ECOG)-Performance-Status<br>• Change in Karnofsky-Performance-Status<br>• Change in Quality of life (QoL) overall status <br>• Change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) <br>• Change in left ventricular ejection fraction (LVEF)<br>• Change in glomerular filtration rate (eGFR)<br><br>;Timepoint(s) of evaluation of this end point: Baseline and at end of study, if not otherwise specified in section E.5.2

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