Blood and Lymph Conditions

All Conditions

Immune System Diseases

Behaviors and Mental Disorders

Anemia

Lymphoproliferative Disorders

Quality of Life

Hematinics

All Drugs and Chemicals

Epoetin Alfa

Participants with solid and lymphoid malignancies will receive subcutaneous or intravenous epoetin beta at a dose of 150 IU per kg of body weight thrice weekly.

Participants with lymphoid malignancies will receive subcutaneous or intravenous epoetin beta at a dose of 30000 IU once weekly.

Epoetin beta subcutaneously or intravenously at a dose of 150 IU per kg of body weight thrice weekly or 30000 IU once weekly.

Epoetin beta

Clinical Trials

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.

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

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

Clinical response to epoetin beta is characterized as an increase of hemoglobin level by greater than or equal to (\>=) 2 grams per liter (g/L) against baseline with no blood transfusions within the 6 previous weeks. Results were presented for participants who received 150 IU/kg and those received 30000 IU doses.

Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>= 2 g/L against baseline with no blood transfusions within the 6 previous weeks. Results were presented for participants who received 150 IU/kg and those received 30000 IU doses.

Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>= 2 g/L against baseline with no blood transfusions within the 6 previous weeks. Results were presented for participants who received initial dose at 150 IU/kg and those received initial dose at 30000 IU/kg doses.

The SF-36 evaluates 36 questions related to participant-rated quality of life using 7 domains: physical and social functioning, physical and emotional role limitations, overall health, vitality, and mental health. The total score is the average of the individual question scores, which is scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants.

A scale of the quality of life IV was developed for stratification of participants depending on the degree of lowering of the quality of life. The analysis has been performed based on the quality of life IV of a participant with a population norm (nIV). The following grades of the quality of life IV reduction were determined: 1) No quality of life reduction (no differences between participant IV and nIV); 2) Minor reduction of the IV quality of life (IV reduction at \<25% of nIV); 3) Moderate reduction of the IV quality of life (IV reduction at 25-50% of nIV); 4) Significant reduction of the IV quality of life (IV reduction at 51-75% of nIV); 5) Critical reduction of the IV quality of life (IV reduction at \>75% of nIV).

A scale of the quality of life IV was developed for stratification of participants depending on the degree of lowering of the quality of life. The analysis has been performed based on the quality of life IV of a participant with a nIV. The following grades of the quality of life IV reduction were determined: 1) No quality of life reduction (no differences between participant IV and nIV); 2) Minor reduction of the IV quality of life (IV reduction at \<25% of nIV); 3) Moderate reduction of the IV quality of life (IV reduction at 25-50% of nIV); 4) Significant reduction of the IV quality of life (IV reduction at 51-75% of nIV); 5) Critical reduction of the IV quality of life (IV reduction at \>75% of nIV).

Quality of life related response to treatment was determined for each participant. Depending on the change of grade of the quality of life IV, quality of life related responses to treatment were characterized as improvement or stabilization.

Fatigue was assessed by a digital rating scale (0 to 10) of MD Anderson Symptom Inventory (MDASI) cancer participant symptom assessment questionnaire. The following fatigue grades were used: 1) Mild fatigue: score 1-3; 2) Moderate fatigue: score 4-6; 3) Severe fatigue: score 7-10. Score 1-3 fatigue was classified as insignificant; score 4-10 fatigue was assessed as significant.

Fatigue severity was assessed by a digital rating scale (0 to 10) of MDASI cancer participant symptom assessment questionnaire. The following fatigue grades were used: 1) Mild fatigue: score 1-3; 2) Moderate fatigue: score 4-6; 3) Severe fatigue: score 7-10. Score 1-3 fatigue was classified as insignificant; score 4-10 fatigue was assessed as significant.

Fatigue was assessed by a digital rating scale (0 to 10) of MDASI cancer participant symptom assessment questionnaire. The following fatigue grades were used: 1) Mild fatigue: score 1-3; 2) Moderate fatigue: score 4-6; 3) Severe fatigue: score 7-10. Score 1-3 fatigue was classified as insignificant; score 4-10 fatigue was assessed as significant.

Percentage of participants with different symptoms (sleep disorders, depressed mood, lethargy, numbness, appetite disorders, and grief) of MDASI cancer participant symptom assessment questionnaire is presented.

Symptoms' type was assessed by a digital rating scale (0 to 10) of MDASI cancer participant symptom assessment questionnaire. Severity grades used for assessment of symptoms severity: 1) Minor symptom, score 1-4; 2) Moderate symptom: score 5-6 and Severe symptom: Score 7-10).

Symptoms' severity was assessed by a digital rating scale (0 to 10) of MDASI cancer participant symptom assessment questionnaire. The following severity grades were used for assessment of symptoms severity: 1) minor symptom, score 1-4; 2) moderate symptom: score 5-6; and 3) severe symptom: score 7-10.

The number of concomitant symptoms was assessed in each participant. As a participant may concomitantly experience symptoms of various intensity, the following groups of participants were assessed based on the number and severity of symptoms: 1) \>=7 moderate and severe symptoms (score \>=5); 2) \<7 moderate and severe symptoms; 3) Only mild symptoms (score 1-4).

The SF-36 evaluates 36 questions related to participant-rated quality of life using 7 domains: physical and social functioning, physical and emotional role limitations, overall health, vitality, and mental health. The total score is the average of the individual question scores, which is scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants. Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>=2 g/L against baseline with no blood transfusions within the 6 previous weeks.

Percentage of participants with different symptoms (fatigue, sleep disorders, depressed mood, lethargy, grief, appetite disorders, and numbness) who had clinical response is presented. Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>= 2 g/L with no blood transfusions within the 6 previous weeks.

Percentage of participants with different symptoms (fatigue, sleep disorders, depressed mood, lethargy, grief, appetite disorders, and numbness) who had clinical response is presented. Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>= 2 g/L against baseline with no blood transfusions within the 6 previous weeks.

Severity grades on a scale of 0-10, were used for assessment of symptoms severity: 1) Minor symptom, score 1-4; 2) Moderate symptom: score 5-6 and Severe symptom: Score 7-10). Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>=2 g/L against baseline with no blood transfusions within the 6 previous weeks.

Severity grades on a scale of 0-10 were used for assessment of symptoms severity. The following severity grades were used: 1) Minor symptom: score 1-4; 2) Moderate symptom: score 5-6; and 3) Severe symptom: score 7-10. Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>=2 g/L against baseline with no blood transfusions within the 6 previous weeks.

Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>= 2 g/L against baseline with no blood transfusions within the 6 previous weeks. Results were presented for participants with lymphoproliferative disorders and solid tumors who received 30000 IU dose.

The SF-36 evaluates 36 questions related to participant-rated quality of life using 7 domains: physical and social functioning, physical and emotional role limitations, overall health, vitality, and mental health. The total score is the average of the individual question scores, which is scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants. Results are presented for participants with lymphoproliferative disorders and solid tumors who received 30000 IU dose.

A scale of the quality of life IV was developed for stratification of participants depending on the degree of lowering of the quality of life. The analysis has been performed based on the quality of life IV of a participant with a nIV. The following grades of the quality of life IV reduction were determined: 1) No quality of life reduction (no differences between participant IV and nIV); 2) Minimal reduction of the IV quality of life (IV reduction at \<25% of nIV); 3) Moderate reduction of the IV quality of life (IV reduction at 25-50% of nIV); 4) Severe reduction of the IV quality of life (IV reduction at 51-75% of nIV); 5) Critical reduction of the IV quality of life (IV reduction at \>75% of nIV). Results are presented for participants with lymphoproliferative disorders and solid tumors.

Percentage of participants with different symptoms (fatigue, sleep disorders, depressed mood, lethargy, numbness, appetite disorders, and grief) is presented. Results were presented for participants with lymphoproliferative disorders (LD) and solid tumors (STS) who received 30000 IU dose.

Severity grades on a scale of 0-10 were used for assessment of symptoms severity. The following severity grades were used: 1) Minor symptom: score 1-4; 2) Moderate symptom: score 5-6; and 3) Severe symptom: score 7-10. Results are presented for participants with lymphoproliferative disorders and solid tumors who received 30000 IU dose.

Severity grades on a scale of 0-10, were used for assessment of symptoms severity: 1) Minor symptom, score 1-4; 2) Moderate symptom: score 5-6 and 3) Severe symptom: Score 7-10. Results were presented for participants with lymphoproliferative disorders (LD) and solid tumors (STS) who received 30000 IU dose.

Clinical response to epoetin beta is characterized as an increase of hemoglobin level by greater than or equal to (\>=) 2 grams per liter (g/L) against baseline with no blood transfusions within the 6 previous weeks. Results are presented for participants who received 150 IU/kg and those received 30000 IU doses.

Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>= 2 g/L against baseline with no blood transfusions within the 6 previous weeks. Results are presented for participants who received 150 IU/kg and those received 30000 IU doses.

Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>= 2 g/L against baseline with no blood transfusions within the 6 previous weeks. Results are presented for participants who received initial dose at 150 IU/kg and those received initial dose at 30000 IU/kg doses.

Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>= 2 g/L against baseline with no blood transfusions within the 6 previous weeks. Results are presented for participants who received mixed dosing regimen with initial dose at 150 IU/kg and those received initial dose at 30000 IU/kg doses.

Quality of life related response to treatment was determined for each participant. Depending on the change of grade of the quality of life IV, quality of life related responses to treatment were characterized as improvement or stabilization. Quality of life related responses to treatment was characterized as stabilization if no changes in the quality of life IV were observed. Quality of life related responses to treatment was characterized as improvement when quality of life IV was changed positively (positive changes in the quality of life IV).

Number of participants with different symptoms (sleep disorders, depressed mood, lethargy, numbness, appetite disorders, and grief) of MDASI cancer participant symptom assessment questionnaire is presented. Symptoms' severity was assessed by a digital rating scale (0 to 10) of MDASI cancer participant symptom assessment questionnaire. Participants were asked to rate severity of each symptom; each item rated from 0 to 10, with 0 = symptom not present and 10 = severe symptom.

Symptoms' severity was assessed by a digital rating scale (0 to 10) of MDASI cancer participant symptom assessment questionnaire. The following severity grades were used for assessment of symptoms severity: 1) minor symptom: score 1-4; 2) moderate symptom: score 5-6; and 3) severe symptom: score 7-10. Participants who had a reduction in scores from moderate-to-severe to mild were considered improved.

The number of concomitant symptoms was assessed in each participant. As a participant may concomitantly experience symptoms of various intensity, the following groups of participants were assessed based on the number and severity of symptoms: 1) \>=7 moderate and severe symptoms (score \>=5); 2) \<7 moderate and severe symptoms (score \>=5); 3) Only mild symptoms (score 1-4).

The number of concomitant symptoms was assessed in each participant. As a participant may concomitantly experience symptoms of various intensity, the following groups of participants were assessed based on the number and severity of symptoms: 1) \>=7 moderate and severe symptoms (score \>=5); 2) \<7 moderate and severe symptoms (score \>=5); 3) only mild symptoms (score 1-4).

Number of participants with different symptoms (fatigue, sleep disorders, depressed mood, lethargy, grief, appetite disorders, and numbness) who had clinical response is presented. Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>= 2 g/L against baseline with no blood transfusions within the 6 previous weeks.

Clinical response to epoetin beta is characterized as an increase of hemoglobin level by \>= 2 g/L against baseline with no blood transfusions within the 6 previous weeks. Results are presented for participants with lymphoproliferative disorders and solid tumors who received 30000 IU dose.

Number of participants with different symptoms (fatigue, sleep disorders, depressed mood, lethargy, numbness, appetite disorders, and grief) is presented. Results are presented for participants with lymphoproliferative disorders and solid tumors who received 30000 IU dose.

Spots Global Cancer Trial Database for 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

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