Comparison of two ways of iron intake for patients with colorectal cancer and iron deficiency.

Phase 1

• Conditions: Iron deficiency anemia in patients with metastatic or inoperable colorectal cancer; MedDRA version: 20.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000246-30-DE
• Lead Sponsor: IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-16
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Rise or normalization of hemoglobin;Secondary Objective: - Fatigue<br>- Quality of life<br>- Gradient of manual force<br>- Number of allogenic blood transfusions (in total and per patient)<br>- Time until rise or normalisation of hemoglobin<br>- Genesis of the iron deficiency anemia<br>- Number, dose and duration of therapy with recombinant erythropoietin<br>- Inflammatory parameters<br>- Influence nutritional status on iron deficiency anemia and therapy success<br>- Tolerance and toxicity<br>- Dropout rate due to toxicity or patient will<br>- Overall survival;Primary end point(s): Rise of hemoglobin by 2g/dl or normalization (12g/dl);Timepoint(s) of evaluation of this end point: 12 weeks after baseline