A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the Cervix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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The purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/L versus from 100 to 110 g/L, with red cell concentrate (RCC) transfusion, in women having chemo-radiation for cancer of the cervix.

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Detailed Description

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Conditions

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Cervical Cancer Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Maintain hemoglobin level above 120 g/L

Hemoglobin level from 120 g/L to 130 g/L

Group Type EXPERIMENTAL

Blood transfusion

Intervention Type PROCEDURE

Blood transfusion to maintain hemoglobin level above 120 g/L

Maintain hemoglobin level above 100 g/L

Hemoglobin level from 100 g/L to 110 g/L

Group Type ACTIVE_COMPARATOR

Blood transfusion

Intervention Type PROCEDURE

Blood transfusion to maintain hemoglobin level above 100 g/L

Interventions

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Blood transfusion

Blood transfusion to maintain hemoglobin level above 120 g/L

Intervention Type PROCEDURE

Blood transfusion

Blood transfusion to maintain hemoglobin level above 100 g/L

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Previously untreated cervix cancer
* FIGO stage IB2, II, IIIB, IVA
* Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation