NCT01701310

Brief Summary

116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric carboxymaltose (intervention). It is hypothesized that intravenous iron supplementation is more efficacious than oral iron therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2012

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

2.7 years

First QC Date

March 21, 2012

Last Update Submit

October 27, 2016

Conditions

AnemiaColorectal Neoplasm

Keywords

AdenocarcinomaAnemiaBlood TransfusionColorectal surgeryPreoperative carePerioperative carePostoperative careIronHematinicsHepcidinQuality of lifePostoperative complications

Outcome Measures

Primary Outcomes (1)

  • To determine if the use of intravenous ferric carboxymaltose can reduce the need for allogeneic blood transfusion compare to oral ferrous sulphate in patients with colorectal adenocarcinoma related anaemia

    To investigate if the number of units transfused per participant, the number of participants whom receive a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at review in outpatient clinic 6 - 12 weeks post operatively.

    0 - 6 to 12 weeks

Secondary Outcomes (5)

  • To determine differences in hemoglobin and hematinic markers between the groups.

    Enrollment to 6-12 weeks postoperatively

  • To determine differences in hepcidin levels in relation to blood profile changes in participants in the intravenous group.

    Enrollment to 6-12 weeks postoperatively.

  • To determine differences in colonic mucosal expression of iron transport proteins, C-myc and NKD1 between the groups

    At point of operation only

  • To determine differences in postoperative outcomes between the groups.

    Enrollment to 6-12 weeks postoperatively

  • To determine differences in anemia symptomatology response between groups.

    Enrollment to 6-12 weeks postoperatively

Study Arms (2)

Ferric carboxymaltose

EXPERIMENTAL
Drug: Ferric carboxymaltose

Ferrous Sulphate

ACTIVE COMPARATOR
Drug: Ferrous Sulphate

Interventions

Ferric carboxymaltoseDRUG

A minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation.

Also known as: Ferinject®
Ferric carboxymaltose
Ferrous SulphateDRUG

(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period

Ferrous Sulphate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with histologically proven colorectal adenocarcinoma.
  • Anemic at point of diagnosis of colorectal adenocarcinoma. (Haemoglobin values of \<12 g/dL for males and \<11 g/dL for females)
  • Medically fit for surgery.
  • Date of planned surgery is \>14 days from date of planned initiation of intervention (intravenous ferric carboxymaltose /oral ferrous sulphate).
  • Able and willing to comply with all study requirements.
  • Willing to allow his/her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

You may not qualify if:

  • Female participants who are pregnant, lactating or planning a pregnancy during the course of the study.
  • Previous gastric, small bowel or colorectal surgery (where ≥50% of stomach or terminal ileum has been resected)
  • Current chemotherapeutic treatment.
  • Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established inflammatory disorders or chronic renal disease).
  • Known haematological disease.
  • Features necessitating urgent surgery (e.g. obstructive symptoms).
  • Previous allergy to intravenous iron or related iron products.
  • Significant symptomatic anemia necessitating urgent transfusion (e.g. cardiovascular compromise)
  • Patients who are unable to consent.
  • Significant renal or hepatic impairment.
  • Donation of blood during the study.
  • Participants who have participated in another research study involving an investigational product in the past 12 weeks
  • Prisoners and minors (\<18 years)
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Nottingham University Hospitals NHS Trust

Nottingham, Nottingham, NG7 2UH, United Kingdom

Location

University Hospital Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

University Hospitals Bristol Foundation NHS Turst

Bristol, BS2 8HW, United Kingdom

Location

Derby Hospital NHS Foundation Trust

Derby, DE22 3NE, United Kingdom

Location

St James University Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

Yeovil District Hospital NHS Foundation Trust

Yeovil, BA21 4AT, United Kingdom

Location

MeSH Terms

Conditions

AnemiaColorectal NeoplasmsAdenocarcinomaPostoperative Complications

Interventions

ferric carboxymaltoseferrous sulfate

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Austin G Acheson, MBBS MD FRCS

    Nottingham University Hospitals NHS Trust, Nottingham University, School of Clinical Sciences, Division of GI Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

October 5, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

GB(8)