Patients with various Blood Malignancies who are candidates for Hematopoietic Stem Cell Transplantation.. Hodgkin lymphoma
Conditions
Interventions
Intervention 1: Intervention group: 25 mg of Agomelatine drug from Agulip brand manufactured by Tadbir Kalaye Jam (tekaje) company will be taken orally by the patient every night during hospitalizatio
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients' satisfaction to enter the study Patients aged more than 18 years and less than 75 years old who are candidates for bone marrow stem cell transplantation. Weight of at least 40 kg Creatinine clearance = 30 mL/min due to renal elimination of drug metabolites Liver enzymes (ALT, AST) less than three times the upper limit of normal If the patients suffer from anxiety or depression, they are equally divided into two groups, case and control.
Exclusion criteria
Exclusion criteria: Patients' lack of consent to enter the study Pregnancy and breastfeeding History of allergy to agomelatine or any of the components of the drug formulation History of underlying liver, kidney, thyroid disorders and untreated anemia in patients History of bipolar disorder, mania and hypomania Taking drugs that affect appetite, such as vitamins of group B and zinc Consumption of stimulants such as amphetamine derivatives, or consumption of narcotic drugs Simultaneous use of drugs with significant interactions with agomelatine, such as rifampin, ciprofloxacin, and fluvoxamine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Quality. Timepoint: At the Beginning of the Patient's Hospitalization and before the Intervention, At the Time of Neutropenia and At the End of the Hospitalization and before Discharge. Method of measurement: Pittsburgh Sleep Quality Index.;Hospital Anxiety and Depression Score. Timepoint: At the Beginning of the Patient's Hospitalization and before the Intervention, At the Time of Neutropenia and at the End of the Hospitalization and before Discharge. Method of measurement: Hospital Anxiety and Depression Scale Questionnaire.;Anorexia. Timepoint: At the Beginning of the Patient's Hospitalization and before the Intervention, At the Time of Neutropenia and at the End of the Hospitalization and before Discharge. Method of measurement: Council on Nutrition Appetite Questionnaire.;Fatigue level. Timepoint: At the Beginning of the Patient's Hospitalization and before the Intervention, At the Time of Neutropenia and at the End of the Hospitalization and before Discharge. Method of measurement: Brief Fatigue Inventory Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospitalization. Timepoint: At the End of the Study. Method of measurement: Counting days of hospitalization.;The need to take sleep aids. Timepoint: During the entire hospital stay. Method of measurement: Registering and reporting the number of patients who need to be prescribed hypnotic drugs in each study group. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaria Tavakoli Ardakani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed