Metastatic Colorectal Cancer
Conditions
Keywords
MCRC, iron substitution, iron deficiency anemia
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.
Interventions
DRUGFerInject
FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
DRUGFerro sanol
200 mg ferro sanol per day over 12 weeks
Sponsors
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rise or normalization of hemoglobin | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life as measured by EORTC-C30 | 12 weeks | — |
| Handgrip strength as measured by Hydraulic Hand Dynamometer | 12 weeks | — |
| Number of allogenic blood transfusions (in total and per patient) | 12 weeks | — |
| Time until rise or normalisation of hemoglobin | 12 weeks | — |
| Genesis of the iron deficiency anemia | 12 weeks | — |
| Number of therapy with recombinant erythropoietin | 12 weeks | — |
| Dose of therapy with recombinant erythropoietin | 12 weeks | — |
| Fatigue as measured by EORTC-QLQ-FA13 | 12 weeks | — |
| Inflammatory parameters | 12 weeks | — |
| Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002) | 12 weeks | — |
| Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002) | 12 weeks | — |
| Tolerance | 12 weeks | — |
| Incidence and severity of adverse events | 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. |
| Dropout rate due to toxicity or patient will | 12 weeks | — |
| Overall survival | 12 weeks | — |
| Duration of therapy with recombinant erythropoietin | 12 weeks | — |
Countries
Germany
Outcome results
None listed