Health Condition 1: R530- Neoplastic (malignant) related fatigue
Conditions
Interventions
Intervention1: MODAFINIL:100MG TABLET OD: 100 mg tablet will be given once daily orally after breakfast for 14 days duration
Control Intervention1: DEXAMETHASONE:4MG TABLET OD: 4 mg tablet will be giv
Sponsors
Burdwan Medical College and Hospital
Dr Sanatan Banerjee
Dr Sandip Mukhopadhyay
Dr Supreeti Biswas
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who received at least 3 cycles of chemotherapy and last chemo cycle within past 3 months or completed a course of curative/palliative radiotherapy 2.Eastern Cooperative Oncology Group(ECOG) Performance status: 0 to 2 3.No surgery within last 4 weeks of enrolment in the study 4.Screening score >5 on a 0 to 10 numeric rating scale(NRS) of fatigue severity(using question, â??How would you rate your worst fatigue during the past week on a scale of 0 to 10, where 0 is â??no fatigue at allâ?? and 10 is the â??worst fatigue imaginableâ?? 5.Presence of >3 symptoms during previous 24 hours with average intensity of >4 on Edmonton Symptom Assessment Scale 6.Normal cognition 7.Literacy status >standard 5 8.Survival expectancy > 2 months 9.Patients giving informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1.History of previous intake of modafinil or any psychostimulant such as amphetamine, methylphenidate or a monoamine oxidase inhibitor or tricyclic antidepressant or clonidine , on a regular basis within past 30 days 2.Pregnancy or Lactation 3.Haemoglobin 4.Absolute neutrophil count 5.Fever 6.Acute infections or any serious concurrent illness 7.History of acquired immunodeficiency syndrome 8.Uncontrolled hypertension 9.Uncontrolled diabetes 10.Known thyroid disease 11.CNS metastasis 12.Any history of clinically significant cardiac , respiratory, renal and hepatic disorder 13.Any history of alcohol and substance abuse/ dependence 14.Presence of glaucoma 15.Severe headache, seizure disorder, narcolepsy 16.Mental retardation or any psychiatric disorder 17.Non compliant patients who are unable to give consent for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in score in FACIT-F,a validated 13-item subscale of the FACIT measurement system, used to measure cancer-related fatigue Timepoint: Day 14 to Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in quality of life by using FACIT-F full scale score 2.Incidences of adverse drug reactions(ADR) during the study period and analyzed by WHO-UMC scale Timepoint: Day 14 to Day 21 | — |
Countries
India
Contacts
Public ContactUttiya Deb
Burdwan Medical College and Hospital
Outcome results
None listed