Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors

Anemia Clinical Trial

Official title:

Phase 2 Study Evaluating the Efficacy of Epoetin Beta (Neocormon®) For Fatigue and Quality of Life of Patients Receiving Palliative Care for a Solid Malignant Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559195
• Other study ID #: CDR0000574173
• Secondary ID: CHUL-NEOPALIAREC
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: May 13, 2011
• Start date: November 2005

Study information

• Verified date: May 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve fatigue in patients with malignant solid tumors receiving palliative care.

PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and anemia in patients receiving palliative care for malignant solid tumors.

Description:

OBJECTIVES:

Primary

• Evaluate the impact of epoetin beta on fatigue and quality of life of patients receiving palliative care for malignant solid tumors.

Secondary

• Evaluate the impact of epoetin beta on hemoglobin level (increase > 2 g/dL).

OUTLINE: Patients receive epoetin beta subcutaneously once a week for up to 3 months.

Fatigue, quality of life, and hemoglobin and reticulocyte levels are assessed every 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant solid tumor

• No hematologic malignancy

• Hemoglobin < 10.5 g/dL (anemic)

• Receiving palliative care only

PATIENT CHARACTERISTICS:

• Life expectancy > 6 months

• Negative pregnancy test

• Fertile patients must use effective contraception

• No chronic anemia requiring treatment (e.g., thalassemia or sickle cell disease)

• No uncontrolled hypertension

• No allergy to any drugs or components used in the study

• Not a prisoner or under guardianship or trusteeship

• No mental disability that impairs a clear understanding of the study requirements

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 2 months since prior specific anticancer therapy (e.g., chemotherapy, hormonal therapy, targeted therapy, or immunotherapy)

• More than 1 month since prior and no concurrent participation in another clinical trial

Study Design

Allocation: Non-Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia
• Fatigue
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• epoetin beta

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
France	Centre Hospital Regional Universitaire de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospital Regional Universitaire de Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue
Primary	Quality of life
Secondary	Hemoglobin level