ISRCTN13370767CompletedPhase 4
ICaRAS (IV Iron for Cancer-Related Anaemia Symptoms) – a feasibility study of intravenous iron therapy for anaemia in palliative cancer care
ottingham University Hospitals NHS Foundation Trust0 sites34 target enrollmentStarted: September 5, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 34
Study Overview
Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36609173/ (added 09/01/2023)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Age =18 years
- •2. Histologically proven solid tumour
- •3. Haemoglobin < 130g/L men and <120 g/L women
- •4. ECOG (Eastern Cooperative Oncology Group, Oken 1982) performance status 0-2
- •5. Moderate to severe fatigue (numeric rating scale score = 4 out of 10)
- •6. Cancer not amenable to curative treatment
Exclusion Criteria
- •1. Evidence of iron overload or disturbance of iron utilisation e.g. haemachromotosis
- •2. Previous allergy to iron or related iron products
- •3. Evidence of active bleeding or untreated infection
- •4. Concurrent anti-cancer chemotherapy and/or immunotherapy and/or radiotherapy (within 8 weeks)
- •5. Untreated haematological malignancy
- •6. Female participants who are pregnant, lactating or planning a pregnancy during the course of the study
- •7. Patients who are unable to consent
- •8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study
- •9. Thromboembolic event within 3 months unless ongoing treatment with anticoagulation
Investigators
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