Clinical trial NCT00776425: A Study of the Quality of Life and Treatment Response to Once Weekly Epoetin Beta (Recormon) Treatment in Anemic Participants With Solid and Lymphoid Malignancies
Official title: Quality of Life Related Response to Treatment in Anemic Cancer Patients Receiving Recormon and Efficacy of the Drug Dosage 30,000 IU Once Weekly in Patients With Lymphoproliferative Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will investigate Quality of Life response in anemic participants with solid and lymphoid malignancies, who are receiving concomitant chemotherapy. Participants with solid and lymphoid malignancies will receive epoetin beta at a dose of 150 international units per kilogram (IU/kg) three times weekly. Participants with lymphoid malignancies will receive epoetin beta 30000 IU once weekly.


Eligibility criteria: Inclusion Criteria:

* Anemia and prescribed treatment with epoetin beta
* Confirmed diagnosis of a solid or lymphoid hematologic malignancy
* Receiving or scheduled to receive chemotherapy
* Life expectancy of greater than or equal to (\>=6) months

Exclusion Criteria:

* Anemia after bleeding, hemolytic anemia, megaloblastic anemia, anemia in chronic kidney failure, lever and endocrinology diseases
* Contraindications to epoetin beta
* Administration of epoetin beta during chemotherapy (e.g., on the third day after chemotherapy cycle start)
* Bleeding within one month before and/or during study
* Severe infection within one month before and/or during study
* Inability of participant to fill the questionnaires

Primary outcomes:
measure: Percentage of Participants Who Achieved a Clinical Response 3-4 Weeks After Start of Treatment
timeFrame: 3-4 weeks
measure: Percentage of Participants Who Achieved a Clinical Response 6-8 Weeks After Start of Treatment
timeFrame: 6-8 weeks
measure: Percentage of Participants Who Achieved a Clinical Response 10-12 Weeks After Start of Treatment
timeFrame: 10-12 weeks
measure: Percentage of Participants Who Achieved a Clinical Response 3-4 Weeks After Start of Treatment with Mixed Dosing Regimen
timeFrame: 3-4 weeks
measure: Percentage of Participants Who Achieved a Clinical Response 6-8 Weeks After Start of Treatment with Mixed Dosing Regimen
timeFrame: 6-8 weeks
measure: Percentage of Participants Who Achieved a Clinical Response 10-12 Weeks After Start of Treatment with Mixed Dosing Regimen
timeFrame: 10-12 weeks
measure: Quality of Life of Anemic Participants Using Short Form 36 (SF-36) Questionnaire Prior To Treatment
timeFrame: Baseline
measure: Quality of Life of Anemic Participants Using SF-36 Questionnaire 3-4 Weeks After Start of Treatment
timeFrame: 3-4 Weeks
measure: Quality of Life of Anemic Participants Using SF-36 Questionnaire 6-8 Weeks After Start of Treatment
timeFrame: 6-8 Weeks
measure: Quality of Life of Anemic Participants Using SF-36 Questionnaire 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Percentage of Participants With Quality of Life Integral Value (IV) Reduction Prior To Treatment
timeFrame: Baseline
measure: Percentage of Participant With Quality of Life IV Reduction 3-4 Weeks After Start of Treatment
timeFrame: 3-4 Weeks
measure: Percentage of Participant With Quality of Life IV Reduction 6-8 Weeks After Start of Treatment
timeFrame: 6-8 Weeks
measure: Percentage of Participant With Quality of Life IV Reduction 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Percentage of Participant With Characteristics of The Quality of Life Related Response To Treatment 3-4 Weeks After Start of Treatment
timeFrame: 3-4 Weeks
measure: Percentage of Participant With Characteristics of The Quality of Life Related Response To Treatment 6-8 Weeks After Start of Treatment
timeFrame: 6-8 Weeks
measure: Percentage of Participant With Characteristics of The Quality of Life Related Response To Treatment 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Fatigue Severity Score at Baseline
timeFrame: Baseline
measure: Fatigue Severity Score 3-4 Weeks After Start of Treatment
timeFrame: 3-4 Weeks
measure: Fatigue Severity Score 6-8 Weeks After Start of Treatment
timeFrame: 6-8 Weeks
measure: Fatigue Severity Score 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Percentage of Participant With Various Fatigue Severity Prior To Treatment
timeFrame: Baseline
measure: Percentage of Participant With Various Fatigue Severity 3-4 Weeks After Start of Treatment
timeFrame: 3-4 Weeks
measure: Percentage of Participant With Various Fatigue Severity 6-8 Weeks After Start of Treatment
timeFrame: 6-8 Weeks
measure: Percentage of Participant With Various Fatigue Severity 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Percentage of Participant With Different Symptoms Prior to Treatment (MDASI Questionnaire)
timeFrame: Baseline
measure: Percentage of Participant With Different Symptoms 3-4 Weeks After Start of Treatment (MDASI Questionnaire)
timeFrame: 3-4 Weeks
measure: Percentage of Participant With Different Symptoms 6-8 Weeks After Start of Treatment (MDASI Questionnaire)
timeFrame: 6-8 Weeks
measure: Percentage of Participant With Different Symptoms 10-12 Weeks After Start of Treatment (MDASI Questionnaire)
timeFrame: 10-12 Weeks
measure: Severity Score of Different Symptoms Prior toTreatment (MDASI Questionnaire)
timeFrame: Baseline
measure: Severity Score of Different Symptoms 3-4 Weeks After Start of Treatment (MDASI Questionnaire)
timeFrame: 3-4 weeks
measure: Severity Score of Different Symptoms 6-8 Weeks After Start of Treatment (MDASI Questionnaire)
timeFrame: 6-8 Weeks
measure: Severity Score of Different Symptoms 10-12 Weeks After Start of Treatment (MDASI Questionnaire)
timeFrame: 10-12 Weeks
measure: Percentage of Participants With Improvement in Symptoms Severity 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Percentage of Participants With Concomitant Symptoms of Various Severity Prior To Treatment
timeFrame: Baseline
measure: Percentage of Participants With Concomitant Symptoms of Various Severity 3-4 Weeks After Start of Treatment
timeFrame: 3-4 weeks
measure: Percentage of Participants With Concomitant Symptoms of Various Severity 4-6 Weeks After Start of Treatment
timeFrame: 4-6 weeks
measure: Percentage of Participants With Concomitant Symptoms of Various Severity 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Quality of Life of Anemic Participants With Clinical Response Using SF-36 Questionnaire Prior To Treatment
timeFrame: Baseline
measure: Quality of Life of Anemic Participants With Clinical Response Using SF-36 Questionnaire 3-4 Weeks After Start of Treatment
timeFrame: 3-4 weeks
measure: Quality of Life of Anemic Participants With Clinical Response Using SF-36 Questionnaire 6-8 Weeks After Start of Treatment
timeFrame: 6-8 weeks
measure: Quality of Life of Anemic Participants With Clinical Response Using SF-36 Questionnaire 10-12 Weeks After Start of Treatment
timeFrame: 10-12 weeks
measure: Percentage of Participants With Different Symptoms Who Had Clinical Response Prior to Treatment
timeFrame: Baseline
measure: Percentage of Participants With Different Symptoms Who Had Clinical Response 3-4 Weeks After Start of Treatment
timeFrame: 3-4 weeks
measure: Percentage of Participants With Different Symptoms Who Had Clinical Response 6-8 Weeks After Start of Treatment
timeFrame: 6-8 weeks
measure: Percentage of Participants With Different Symptoms Who Had Clinical Response 10-12 Weeks After Start of Treatment
timeFrame: 10-12 weeks
measure: Severity Score of Different Symptoms in Anemic Participants With Clinical Response Prior To Treatment
timeFrame: Baseline
measure: Severity Score of Different Symptoms in Anemic Participants With Clinical Response 3-4 Weeks After Start of Treatment
timeFrame: 3-4 weeks
measure: Severity Score of Different Symptoms in Anemic Participants With Clinical Response 6-8 Weeks After Start of Treatment
timeFrame: 6-8 weeks
measure: Severity Score of Different Symptoms in Anemic Participants With Clinical Response 10-12 Weeks After Start of Treatment
timeFrame: 10-12 weeks
measure: Percentage of Participants With Clinical Response After First 3-4 Weeks of Treatment at 30000 IU Once Weekly Dose
timeFrame: 3-4 Weeks
measure: Percentage of Participants With Clinical Response After Second 3-4 Weeks of Treatment at 30000 IU Once Weekly Dose
timeFrame: 6-8 Weeks
measure: Percentage of Participants With Clinical Response After Third 3-4 Weeks of Treatment at 30000 IU Once Weekly Dose
timeFrame: 10-12 Weeks
measure: Quality of Life in Anemic Participants Receiving Treatment at 30000 IU Once Weekly (SF-36 Questionnaire) Prior to Treatment
timeFrame: Baseline
measure: Quality of Life in Anemic Participants Receiving Treatment at 30000 IU Once Weekly (SF-36 Questionnaire) 3-4 Weeks After Start of Treatment
timeFrame: 3-4 weeks
measure: Quality of Life in Anemic Participants Receiving Treatment at 30000 IU Once Weekly (SF-36 Questionnaire) 6-8 Weeks After Start of Treatment
timeFrame: 6-8 Weeks
measure: Quality of Life in Anemic Participants Receiving Treatment at 30000 IU Once Weekly (SF-36 Questionnaire) 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Number of Participants With Lymphoproliferative Disorders and Solid Tumors Who Had Quality of Life IV Reduction Prior to Treatment
timeFrame: Baseline
measure: Number of Participants With Lymphoproliferative Disorders and Solid Tumors Who Had Quality of Life IV Reduction 3-4 Weeks After Start of Treatment
timeFrame: 3-4 Weeks
measure: Number of Participants With Lymphoproliferative Disorders and Solid Tumors Who Had Quality of Life IV Reduction 6-8 Weeks After Start of Treatment
timeFrame: 6-8 Weeks
measure: Number of Participants With Lymphoproliferative Disorders and Solid Tumors Who Had Quality of Life IV Reduction 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Percentage of Participants With Different Symptoms Categorized by Lymphoproliferative Disorders and Solid Tumors Prior Receiving Treatment at 30000 IU Once Weekly
timeFrame: Baseline
measure: Percentage of Participants With Different Symptoms Categorized by Lymphoproliferative Disorders and Solid Tumors 3-4 Weeks After Start of Treatment at 30000 IU Once Weekly
timeFrame: 3-4 weeks
measure: Percentage of Participants With Different Symptoms Categorized by Lymphoproliferative Disorders and Solid Tumors 6-8 Weeks After Start of Treatment at 30000 IU Once Weekly
timeFrame: 6-8 weeks
measure: Percentage of Participants With Different Symptoms Categorized by Lymphoproliferative Disorders and Solid Tumors 10-12 Weeks After Start of Treatment at 30000 IU Once Weekly
timeFrame: 10-12 Weeks
measure: Severity Score of Different Symptoms in Participants With Lymphoproliferative Disorders and Solid Tumors Prior to Treatment at 30000 IU Once Weekly
timeFrame: Baseline
measure: Severity Score of Different Symptoms in Participants With Lymphoproliferative Disorders and Solid Tumors 3-4 Weeks After Start of Treatment at 30000 IU Once Weekly
timeFrame: 3-4 weeks
measure: Severity Score of Different Symptoms in Participants With Lymphoproliferative Disorders and Solid Tumors 6-8 Weeks After Start of Treatment at 30000 IU Once Weekly
timeFrame: 6-8 weeks
measure: Severity Score of Different Symptoms in Participants With Lymphoproliferative Disorders and Solid Tumors 10-12 Weeks After Start of Treatment at 30000 IU Once Weekly
timeFrame: 10-12 weeks
measure: Percentage of Participants With Improvement in Symptoms Severity Categorized by Lymphoproliferative Disorders and Solid Tumors 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Number of Participants Who Achieved a Clinical Response 3-4 Weeks After Start of Treatment
timeFrame: 3-4 weeks
measure: Number of Participants Who Achieved a Clinical Response 6-8 Weeks After Start of Treatment
timeFrame: 6-8 weeks
measure: Number of Participants Who Achieved a Clinical Response 10-12 Weeks After Start of Treatment
timeFrame: 10-12 weeks
measure: Number of Participants Who Achieved a Clinical Response With Mixed Drug Dosing Regimen, 3-4 Weeks After Start of Treatment
timeFrame: 3-4 weeks
measure: Number of Participants Who Achieved a Clinical Response With Mixed Drug Dosing Regimen, 6-8 Weeks After Start of Treatment
timeFrame: 6-8 weeks
measure: Number of Participants Who Achieved a Clinical Response With Mixed Dosing Regimen, 10-12 Weeks After Start of Treatment
timeFrame: 10-12 weeks
measure: Number of Participants With Quality of Life IV Reduction 3-4 Weeks After Start of Treatment
timeFrame: 3-4 Weeks
measure: Number of Participants With Quality of Life IV Reduction 6-8 Weeks After Start of Treatment
timeFrame: 6-8 Weeks
measure: Number of Participants With Quality of Life IV Reduction 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Number of Participants With Characteristics of the Quality of Life Related Response To Treatment 3-4 Weeks After Start of Treatment
timeFrame: 3-4 Weeks
measure: Number of Participants With Characteristics of the Quality of Life Related Response To Treatment 6-8 Weeks After Start of Treatment
timeFrame: 6-8 Weeks
measure: Number of Participants With Characteristics of the Quality of Life Related Response To Treatment 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Percentage of Participants With Various Fatigue Severity 3-4 Weeks After Start of Treatment
timeFrame: 3-4 Weeks
measure: Percentage of Participants With Various Fatigue Severity 6-8 Weeks After Start of Treatment
timeFrame: 6-8 Weeks
measure: Percentage of Participants With Various Fatigue Severity 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Number of Participants With Different Symptoms 3-4 Weeks After Start of Treatment (MDASI Questionnaire)
timeFrame: 3-4 Weeks
measure: Number of Participant With Different Symptoms 6-8 Weeks After Start of Treatment (MDASI Questionnaire)
timeFrame: 6-8 Weeks
measure: Number of Participants With Different Symptoms 10-12 Weeks After Start of Treatment (MDASI Questionnaire)
timeFrame: 10-12 Weeks
measure: Number of Participants With Improvement in Symptoms Severity 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Number of Participants With Concomitant Symptoms of Various Severity 3-4 Weeks After Start of Treatment
timeFrame: 3-4 weeks
measure: Number of Participants With Concomitant Symptoms of Various Severity 6-8 Weeks After Start of Treatment
timeFrame: 6-8 weeks
measure: Number of Participants With Concomitant Symptoms of Various Severity 10-12 Weeks After Start of Treatment
timeFrame: 10-12 Weeks
measure: Number of Participants With Different Symptoms Who Had Clinical Response 3-4 Weeks After Start of Treatment
timeFrame: 3-4 weeks
measure: Number of Participants With Different Symptoms Who Had Clinical Response 6-8 Weeks After Start of Treatment
timeFrame: 6-8 weeks
measure: Number of Participants With Different Symptoms Who Had Clinical Response 10-12 Weeks After Start of Treatment
timeFrame: 10-12 weeks
measure: Number of Participants With Clinical Response After First 3-4 Weeks of Treatment at 30000 IU Once Weekly Dose
timeFrame: 3-4 Weeks
measure: Number of Participants With Clinical Response After Second 3-4 Weeks of Treatment at 30000 IU Once Weekly Dose
timeFrame: 6-8 Weeks
measure: Number of Participants With Clinical Response After Third 3-4 Weeks of Treatment at 30000 IU Once Weekly Dose
timeFrame: 9-12 Weeks
measure: Number of Participants With Different Symptoms Categorized by Lymphoproliferative Disorders and Solid Tumors Before Receiving Treatment at 30000 IU Once Weekly
timeFrame: Baseline
measure: Number of Participants With Different Symptoms Categorized by Lymphoproliferative Disorders and Solid Tumors 3-4 Weeks After Start of Treatment at 30000 IU Once Weekly
timeFrame: 3-4 weeks
measure: Number of Participants With Different Symptoms Categorized by Lymphoproliferative Disorders and Solid Tumors 6-8 Weeks After Start of Treatment at 30000 IU Once Weekly
timeFrame: 6-8 weeks
measure: Number of Participants With Different Symptoms Categorized by Lymphoproliferative Disorders and Solid Tumors 10-12 Weeks After Start of Treatment at 30000 IU Once Weekly
timeFrame: 10-12 Weeks
measure: Number of Participants With Improvement in Symptoms Severity Categorized by Lymphoproliferative Disorders and Solid Tumors 10-12 Weeks After Start of Treatment at 30000 IU Once Weekly
timeFrame: 10-12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
city: Barnaul
country: Russian Federation
city: Belgorod
country: Russian Federation
city: Ivanovo
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kostroma
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Salekhard
country: Russian Federation
city: Soshi
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Surgut
country: Russian Federation
city: Tumen
country: Russian Federation
city: Tver
country: Russian Federation
city: UFA
country: Russian Federation
city: Yaroslavl
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: