Intravenous iron for cancer-related anaemia symptoms

Phase 4

Completed

• Conditions: Anaemia in patients with cancer; Haematological Disorders

• Registration Number: ISRCTN13370767
• Lead Sponsor: ottingham University Hospitals NHS Foundation Trust

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36609173/ (added 09/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-05
• Study Completion: 2020-12-01
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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 Numbers withdrawn (non-concordance)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

Secondary Outcome Measures

Name	Time	Method
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<br>2. Blood transfusion rate recorded by number of units transfused at 4 week and 8 weeks post infusion<br>3. Haemoglobin levels and body iron stores measured in blood samples taken at baseline, 4 weeks and 8 weeks post infusion<br>4. Gut microbiome measured by stool sample analysis at baseline, 4 weeks and 8 weeks<br>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<br>6. Physical condition assessed by scores for the Short Physical Performance Battery (SPPB) protocol at baseline, 4 weeks and 8 weeks post infusion<br>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