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

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ClinicalTrials.gov Identifier: NCT02469480
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: FerInject Drug: Ferro sanol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
Actual Study Start Date : March 2015
Actual Primary Completion Date : May 2020
Actual Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FERRIC CARBOXYMALTOSE
max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
Drug: FerInject
FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).

Active Comparator: ferro sanol(R) duodenal 100 mg
200 mg ferro sanol per day over 12 weeks
Drug: Ferro sanol
200 mg ferro sanol per day over 12 weeks




Primary Outcome Measures :
  1. Rise or normalization of hemoglobin [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469480


Locations
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Sponsors and Collaborators
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Additional Information:
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Responsible Party: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT02469480    
Other Study ID Numbers: FERINJECT
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared.
Keywords provided by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest:
MCRC
iron substitution
iron deficiency anemia
Additional relevant MeSH terms:
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Colorectal Neoplasms
Anemia
Anemia, Iron-Deficiency
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases