ICaRAS - A Feasibility Study of Intravenous Iron Therapy for Anaemia in Palliative Cancer Care

Phase 1

• Conditions: Iron deficiency anaemia secondary to cancer; MedDRA version: 20.0 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-001669-17-GB
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 on-going treatment with anticoagulation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified