A study to compare the efficacy and safety of modafinil in patients suffering from cancer-related fatigue
- Conditions
- Health Condition 1: R530- Neoplastic (malignant) related fatigue
- Registration Number
- CTRI/2018/05/014046
- Lead Sponsor
- Burdwan Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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
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 < 10 gm/dl within 1 week of enrolment
4.Absolute neutrophil count < 1500 /dL within 1 week of enrolment
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in score in FACIT-F,a validated 13-item subscale of the FACIT measurement system, used to measure cancer-related fatigue <br/ ><br>Timepoint: Day 14 to Day 21
- Secondary Outcome Measures
Name Time Method 1.Change in quality of life by using FACIT-F full scale score <br/ ><br>2.Incidences of adverse drug reactions(ADR) during the study period and analyzed by WHO-UMC scale <br/ ><br>Timepoint: Day 14 to Day 21