Prevalence of FID and QoL in Patients With Oncological and With Haematological Malignancies

Prevalence of Functional Iron Deficiency (FID) and Quality of Life (QoL) in Patients With Oncological and With Haematological Malignancies

Prospective single-center observational study assessing prevalence of FID (Laboratory work-up) and Quality of Life (Questionnaire) in adult patients with oncological and with haematological malignancies within four weeks prior to disease-directed therapy.

Study Overview

• Status: Recruiting
• Conditions: Functional Iron Deficiency

Detailed Description

Patients included into the study will have a laboratory work-up assessing the occurence of functional iron deficiency using laboratory parameters (full blood count, reticulocytes, transferrin saturation, serum-ferritin, CRP, ALAT) and have to fill in once the FACT-An questionnaire generating data on Quality of Life at time of study entry.

• Study Type: Observational
• Enrollment (Anticipated): 104

Contacts and Locations

• Study Contact: Name: Axel Rüfer, MD; Phone Number: 0041412055147; Email: axel.ruefer@luks.ch

Study Locations

• Switzerland
  • Luzern, Switzerland, 6000
    • Recruiting
    • Luzerner Kantonsspital
    • Contact: Axel Rüfer, MD; Phone Number: 0041 41 205 51 47; Email: axel.ruefer@luks.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with oncological (solid tumors) and with haematological malignancies (non-solid tumors, including Plasma cell myeloma, lymphoma, myeloproliferative neoplasias [MPN], myelodysplastic syndromes [MDS] and chronic leukemias)

Study entry within four weeks prior to disease-directed systemic therapy

Description

Inclusion Criteria:

• Age > 18 years
• Patients with oncological (solid tumors) and with haematological malignancies (non-solid tumors, including Plasma cell myeloma, lymphoma, myeloproliferative neoplasias [MPN], myelodysplastic syndromes [MDS] and chronic leukemias)
• Within four weeks prior to disease-directed systemic therapy
• Participation in other trials is possible

Exclusion Criteria:

• Known iron deficiency with or without iron substitution p.o. or i.v. within last 8 weeks prior to inclusion into this trial
• Therapy with RBC-transfusions within last 8 weeks prior to inclusion into this trial
• Therapy with ESA within last 8 weeks prior to inclusion into this trial
• Malignancies with acute need for therapeutic intervention (e.g. acute leukemias, superior vena cava obstruction, etc.)
• Pregnancy
• Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the trial
• Inability to give consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is the determination of the prevalence of FID in patients with oncological and with haematological malignancies.	Prevalence of functional iron deficiency in the study population using full blood count, reticulocytes, transferrin saturation, serum-ferritin, CRP and ALAT.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary endpoint is the collection of data on quality of life using FACT-An.	Data on quality of life using FACT-An, which covers a fatigue and anemia subscale, as well as generic QoL domains including physical well-being, functional well-being, emotional well-being and socal well-being subscales - this is done at study entry estimating scores at various subscales of FACT-An.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Investigators: Study Chair: Axel Ruefer, MD, Abteilung Hämatologie, Luzerner Kantonsspital, 6000 Luzern 16, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 16, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 16, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Hematologic Neoplasms; Anemia, Iron-Deficiency
• Other Study ID Numbers: Kantonsspital_Luzern

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No