Intravenous iron for cancer-related anaemia symptoms

ICaRAS (IV Iron for Cancer-Related Anaemia Symptoms) – a feasibility study of intravenous iron therapy for anaemia in palliative cancer care

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13370767

Enrollment

Registered

2018-09-05

Start date

2018-10-01

Completion date

Unknown

Last updated

2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia in patients with cancer Haematological Disorders

Interventions

This study has been designed to assess the feasibility of a larger definitive trial investigating the efficacy of intravenous iron for fatigue and anaemia in palliative cancer care. This feasibility s

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Feasibility assessed based on patient numbers for: 1. Inclusion eligibility 2. Willingness to be recruited (acceptability) 3. Willingness to be randomised (concordance) 4. Study exclusion (screen failures) 5. Numbers withdrawn (non-concordance) 6. Study retention Timepoint(s): Baseline to end of trial participation	—

Secondary

Measure	Time frame
1. Quality of life and fatigue measured using the questionnaires FACIT-F fatigue score, EQ-5D and EORTC QLQc30 at baseline, 4 weeks and 8 weeks post infusion 2. Blood transfusion rate recorded by number of units transfused at 4 week and 8 weeks post infusion 3. Haemoglobin levels and body iron stores measured in blood samples taken at baseline, 4 weeks and 8 weeks post infusion 4. Gut microbiome measured by stool sample analysis at baseline, 4 weeks and 8 weeks 5. Activity levels measured using number of daily steps recorded on a pedometer for 7 days prior to the baseline visit, the 4 and 8 week follow up visits 6. Physical condition assessed by scores for the Short Physical Performance Battery (SPPB) protocol at baseline, 4 weeks and 8 weeks post infusion 7. Change in blood markers to analyse the immune response to iron including hepcidin and cytokine activity measured at baseline, 4 weeks and 8 weeks follow up	—

Measure

Time frame

1. Quality of life and fatigue measured using the questionnaires FACIT-F fatigue score, EQ-5D and EORTC QLQc30 at baseline, 4 weeks and 8 weeks post infusion 2. Blood transfusion rate recorded by number of units transfused at 4 week and 8 weeks post infusion 3. Haemoglobin levels and body iron stores measured in blood samples taken at baseline, 4 weeks and 8 weeks post infusion 4. Gut microbiome measured by stool sample analysis at baseline, 4 weeks and 8 weeks 5. Activity levels measured using number of daily steps recorded on a pedometer for 7 days prior to the baseline visit, the 4 and 8 week follow up visits 6. Physical condition assessed by scores for the Short Physical Performance Battery (SPPB) protocol at baseline, 4 weeks and 8 weeks post infusion 7. Change in blood markers to analyse the immune response to iron including hepcidin and cytokine activity measured at baseline, 4 weeks and 8 weeks follow up

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026