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

Tri-Service General Hospital (TSGH)2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cervical Cancer Anemia

Interventions

Blood transfusionPROCEDURE

Blood transfusion to maintain hemoglobin level above 120 g/L

Blood transfusionPROCEDURE

Blood transfusion to maintain hemoglobin level above 100 g/L

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Previously untreated cervix cancer * FIGO stage IB2, II, IIIB, IVA * Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation Exclusion Criteria: * Hemoglobin level above 125g/L * Lower one-third vaginal involvement * Para-aortic lymphadenopathy

Outcomes

Primary Outcomes

The impact of maintaining hemoglobin levels above 120 g/L versus above 100 g/L

Time frame: 5 years

Data from ClinicalTrials.gov

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