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


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Fatigue

Principal Investigator

Jean-Luc Labourey

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Hospital Regional Universitaire de Limoges

Authority:

United States: Federal Government

Study ID:

CDR0000574173

NCT ID:

NCT00559195

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Anemia
  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • anemia
  • fatigue
  • Anemia
  • Fatigue

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