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

Tri-Service General Hospital

Status and phase: Suspended; Phase 3

Conditions: Anemia; Cervical Cancer

Treatments: Procedure: Blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00921635

TSGHIRB095-05-044

ANZGOG0401

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Maintain hemoglobin level above 120 g/L

Experimental group

Description:

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

Treatment:

Procedure: Blood transfusion

Procedure: Blood transfusion

Maintain hemoglobin level above 100 g/L

Active Comparator group

Description:

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

Treatment:

Procedure: Blood transfusion

Procedure: Blood transfusion