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NCT Number: NCT02469480

Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.

Iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%. About 70% of these patients suffer from iron deficiency anemia (IDA) which adds both physical and cognitive impediments to an already straining chemotherapy. Moreover, a chronic disease like cancer often results in a reduced availability of iron for the body. In clinical practice iron substitution is usually administered orally. Due to low resorption rates, frequent gastric side effects and thus poor patient compliance a parenteral substitution seems to be a better option in terms of efficacy. In the framework of a randomized multicenter clinical trial ('FerInject') a comparison of efficacy parameters of parenteral vs. oral iron substitution will now be conducted in order to identify the best treatment form for clinical practice in oncology. Furthermore detailed quality of life-data (QoL) will be collected in both treatment arms for effect comparison.

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Key information

Conditions

Metastatic Colorectal Cancer Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research, Frankfurt am Main, Hesse, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic or inoperable colorectal carcinoma. No curative therapy available.
  • Current palliative chemotherapy. Patients under conversion therapy must not be enrolled to this study.
  • Iron deficiency anemia: hemoglobin ≤ 10.5 g/dl and transferrin saturation < 20 % and/or serum ferritin < 20 ng/ml
  • Male and female patients aged ≥ 18 years; maturity
  • ECOG ≤ 2
  • Written informed consent
  • Life expectancy > 6 months
  • Body weight ≥ 40 kg

Exclusion criteria

  • Oral or intravenous iron substitution within the last 4 weeks
  • Age < 18 years or body weight < 40 kg
  • Absorption dysfunction due to short bowel syndrome or after gastric resection
  • Therapy with recombinant erythropoietin within the last 4 weeks
  • Chronic diarrhea
  • Chronic inflammatory bowel disease
  • Ferritin > 800 mg/dl at baseline
  • Hypersensitivity or contraindication to ferric carboxymaltose or iron (II) glycine sulphate complex
  • Known vitamin B12 or folic acid anemia
  • Necessary total parenteral nutrition
  • Participation in another interventional study
  • Pregnancy or lactation

Treatment and study plan

Ferinject

Drug

FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).

Ferro sanol

Drug

200 mg ferro sanol per day over 12 weeks

Primary outcomes

  1. Rise or normalization of hemoglobin

    Time frame: 12 weeks

Secondary outcomes

  1. Fatigue as measured by EORTC-QLQ-FA13

    Time frame: 12 weeks

  2. Quality of life as measured by EORTC-C30

    Time frame: 12 weeks

  3. Handgrip strength as measured by Hydraulic Hand Dynamometer

    Time frame: 12 weeks

  4. Number of allogenic blood transfusions (in total and per patient)

    Time frame: 12 weeks

  5. Time until rise or normalisation of hemoglobin

    Time frame: 12 weeks

  6. Genesis of the iron deficiency anemia

    Time frame: 12 weeks

  7. Number of therapy with recombinant erythropoietin

    Time frame: 12 weeks

  8. Dose of therapy with recombinant erythropoietin

    Time frame: 12 weeks

  9. Duration of therapy with recombinant erythropoietin

    Time frame: 12 weeks

  10. Inflammatory parameters

    Time frame: 12 weeks

  11. Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002)

    Time frame: 12 weeks

  12. Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002)

    Time frame: 12 weeks

  13. Tolerance

    Time frame: 12 weeks

  14. Incidence and severity of adverse events

    Time frame: 12 weeks

    incidence and severity of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) Version 4 criteria as assessed at day 1, 8, 15, 36, 50 and 64 and at end of treatment.

  15. Dropout rate due to toxicity or patient will

    Time frame: 12 weeks

  16. Overall survival

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2015
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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