Skip to main content
OpenTrials
Completed

NCT Number: NCT01168349

An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)

This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in daily routine practice in cancer patients with anemia. Data will be collected from patients who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will be followed for 28 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia, Neoplasms Anemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neuilly-sur-Seine, 92521, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, >/=18 years of age
  • Patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological malignancy or an autograft for hematological malignancy
  • Patients for whom treatment with epoetin beta is started at the inclusion visit
  • Life expectancy >/=6 months according to the physician
  • Patients accepting and able to complete a French written questionnaire about his/her professional and social activities at each visit

Exclusion criteria

  • Patients who received erythropoiesis-stimulating agents treatment, or red blood cell transfusion within 4 weeks before enrollment
  • Participation in a clinical trial in onco-hematology
  • Patients with myelodysplasia
  • Patients with more than one active malignancy at the time of enrollment

Treatment and study plan

epoetin beta [NeoRecormon]

Drug

As prescribed by physician

Primary outcomes

  1. Percentage of Participants With Early Treatment Response: Day 28 to 42

    Time frame: Day 28 to 42

    Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.

  2. Percentage of Participants With Early Treatment Response: Day 21 to 42

    Time frame: Day 21 to 42

    Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.

  3. Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion

    Time frame: Baseline up to Week 28

    Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.

  4. Mean Number of RBC Transfusions

    Time frame: Baseline up to Week 28

    Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.

  5. Mean Number of RBC Units

    Time frame: Baseline up to Week 28

    Mean number of units was based on the number of participants with at least 1 RBC transfusion.

  6. Time to First RBC Transfusions

    Time frame: Baseline up to Week 28

    Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used.

  7. Karnofsky Performance Status (KPS): Baseline

    Time frame: Baseline

    KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.

  8. KPS: Week 4 to 6

    Time frame: Week 4 to 6

    KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.

  9. KPS: Week 12 to 16

    Time frame: Week 12 to 16

    KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.

  10. KPS: Week 24 to 28

    Time frame: Week 24 to 28

    KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.

  11. Percentage of Participants With Professional Activity: Baseline

    Time frame: Baseline

    Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment.

  12. Percentage of Participants With At Least 1 Sick Leave

    Time frame: Week 4 Up to Week 28

    Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).

  13. Mean Number of Days of Sick Leave

    Time frame: Week 4 Up to Week 28

    Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).

  14. Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline

    Time frame: Baseline

    Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.

  15. Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6

    Time frame: Week 4 to 6

    Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.

  16. Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16

    Time frame: Week 12 to 16

    Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.

  17. Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28

    Time frame: Week 24 to 28

    Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.

  18. Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6

    Time frame: Baseline, Week 4 to 6

    Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).

  19. Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16

    Time frame: Baseline, Week 12 to 16

    Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).

  20. Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28

    Time frame: Baseline, Week 24 to 28

    Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).

Secondary outcomes

  1. Mean Starting Dose of NeoRecormon® Injection

    Time frame: Baseline

    Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).

  2. Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks

    Time frame: Baseline

  3. Percentage of Participants With Pre-specified Dose and Frequency of Injections

    Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48

    Pre-specified doses and frequency included; 20000 IU/week - Once a week (qw), 30000 IU/week -qw, 30000 IU/week - Twice a week (tw), 30000 IU/week - Once every 2 weeks (q2w), 40000 IU/week - qw, 60000 IU/week - qw, and other. Missing data were not reported.

  4. Percentage of Participants With Subcutaneous (SC) Route of Administration

    Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48

  5. Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU

    Time frame: Baseline up to Week 28

  6. Percentage of Participants With Modifications of NeoRecormon® Regimen

    Time frame: Baseline up to Week 28

    All modifications were based on the change in frequency, route of administration or dose depending on the need for treatment adjustments according to Hb concentration. Percentage of participants with at least 1 modification in NeoRecormon® regimen was reported.

  7. Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment

    Time frame: Baseline up to Week 28

    Percentage of participants with at least 1 temporary discontinuation was reported.

  8. Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment

    Time frame: Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28

  9. Relative Percent Change in Hb Concentration From Baseline Over the Study Period

    Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28

  10. Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL

    Time frame: Baseline up to Week 28

  11. Percentage of Participants With Adequate Iron Status

    Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48

    Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%.

  12. Percentage of Participants With Vitamins Prescription

    Time frame: Week 4 to 6, Week 12 to 16, Week 24 to 48

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 23, 2010
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.