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CTRI Number  CTRI/2024/04/065257 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 02/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To assess and compare effectivity of dexamethasone and methylphenidate in cancer patient who have fatigue  
Scientific Title of Study   A prospective interventional study to compare and assess the effectivity of dexamethasone and methylphenidate on cancer related fatigue at SMS medical college,Jaipur 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Kesavaraj.V 
Designation  Resident Doctor 
Affiliation  Sawai Man Singh medical college and attached hospital  
Address  Department of palliative medicine, SMS medical college, New Sms Campus Rd, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004

Jaipur
RAJASTHAN
302004
India 
Phone  8608682827  
Fax    
Email  kesavraj777@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Ashwin Mathur 
Designation  Senior Professor and Head of department  
Affiliation  Sawai Man Singh medical college and attached hospital  
Address  Department of palliative medicine, New Sms Campus Rd, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004

Jaipur
RAJASTHAN
302004
India 
Phone  9829038756  
Fax    
Email  drmathurashwin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Ashwin Mathur 
Designation  Senior Professor and Head of Department  
Affiliation  Sawai Man Singh medical college and attached hospital  
Address  Department of palliative medicine, SMS medical college,New Sms Campus Rd, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004

Jaipur
RAJASTHAN
302004
India 
Phone  9829038756  
Fax    
Email  drmathurashwin@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrKesavarajV  SMS MEDICAL COLLEGE   RKBC prefabricated ward, Second floor, Department of Palliative Medicine, SMS MEDICAL COLLEGE,New Sms Campus Rd, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN 
8608682827

kesavraj777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMS MEDICAL COLLEGE AND HOSPITAL   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drug dexamethasone and methylphenidate   To compare effectivity of methylphenidate and dexamethasone There will be two following groups 1. Dexamethasone group eligible subjects taking 8mg per day 2. methylphenidate group Eligible subjects taking methylphenidate 40 mg per day 
Comparator Agent  Drug methylphenidate and dexamethasone   Drug dexamethasone 4 mg per oral given twice for 14 days Drug methylphenidate 10mg per oral given four times a day for 14 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Age 18 and above
2. Registered in palliative care centre
3. Suffering from histologically diagnosed advanced cancer
4. Patient with cancer related fatigue score greater than or equal to 4 to 10 on Edmonton symptoms assessment scale
5. Patient giving written informed consent  
 
ExclusionCriteria 
Details 
1. Pregnant and lactating female
2. Known history of hypersensitive to study drugs
3. History of AIDS
4. History of surgery in the last 2 weeks
5. Abnormal T3,T4,TSH
6. Anemia (Hb less than9)
7. Known case of Diabetes mellitus, Hypertension
8. Severe renal impairment,
9. Severe liver impairment,
10. Significant disorder of bone marrow
11. Cardiac conduction defect.
12. Patient taking Antipsychotic, sedative- psychotropic drug. Atropine and its substitute
13. Non co-operative patient
14. Patients who were not able to answer the questionnaires 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Fatigue  Change in fatigue score will be assessed i.e 1 st week and 2 nd week 
 
Secondary Outcome  
Outcome  TimePoints 
1.Effect on appetite
2.Effect on psychological symptoms
3. Adverse events  
1.change in appetite will be assessed i.e. baseline, 1st week,2 nd week
2.change in effect of psychological symptoms will be assessed i.e. baseline, 1st week and 2nd week
3. Adverse events will be assessed i.e baseline,1 st week,2 nd week  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kesavraj777@gmail.com].

  6. For how long will this data be available start date provided 04-03-2024 and end date provided 14-02-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Fatigue is the most frequent and debilitating symptom in patients with advanced-stage cancer

compared to early cancer and cancer survivors, with a prevalence of 60-90% in various

studies". In the palliative care setting, the frequency ranges from 48% to 78% Fatigue adversely impacts the physical, functional, and psychological domams of quality of life, resulting in an inability to perform daily activities and affecting mood, social relationships, and work It may influence patients’ decision-making capabilities regarding future treatment and lead to the refusal of potentially curative treatment. Fatigue may include

three major

features:

1. Easy tiring and reduced capacity to mamtain performance

2. Generalized weakness, defined as the anticipatory sensation of difficulty in initiating a certain activity

3. Mental fitigue, defined as the presence of impaired mental concentration. loss of memory, and emotional lability.

The National Comprehensive Cancer Network defined cancer related fatigue as follows Y’ancer-related fatigue is a distressing persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning

In this setting, it should be distinguished from depression, delirium, drowsiness. Depression in characterized by persistent sadness and lack of interest or pleasure in previously enjoyable activities Delirium frequently presents with fluctuating levels of consciousness and weakness is the term used for lack of physical, muscle, or motor strength.

Among cancer patients, fatigue occurs as a result of both the disease and its treatment. The onset of fatigue may precede the diagnosis or it may occur at any stage in the course of the illness. It may occur after or be exacerbated by chemotherapy, radiotherapy, targeted therapy. immunotherapy, or surgery, and may be present for prolonged periods after these treatments. In patients with advanced cancer, fatigue usually coexists with a number of other symptoms, including pain, anorexia, nausea, vomiting, dyspnoea, sleep disturbance, anxiety, and depression In recent years, as the management of other symptoms (eg pain, dyspnoea, and nausea) has improved, there has been an increased awareness of the importance of recognizing fatigue as a symptom deserving of attention.

In addition, unlike many common symptoms such as pain, the management of fatigue is confounded by limited research and evidence-based treatment options.

Psychostimulants have been used with some success in treating fatigue of various etiologies and are widely regarded to be safe. While controlled studies examining non-pharmacological interventions as well as pharmacological interventions for fatigue related to cancer have beng conducted pharmacological interventions for fatigue in cancer patients have not been extensively studied

Bruera et al recently published two double-blind, randomized controlled trials (RCT), where palliative cancer patients were prescribed methylphenidate or donepezil against placebo for 7days. The authors found that fatigue intensity improved in each of the groups, yet there were no group differences between the active medication groups and placebo groups, suggesting that these medications were not significantly superior to placebo. In an RCT of methylphenidate vs pemoline vs placebo in HIV patients. Breitbart et al also found a placebo effect, however, there was a significant but delayed improvement in fatigue in the two psychostimulant groups, with

significant differences noted from the placebo group emerging at week three of the trial. It is important to test the potential benefit of psychostimulants with an appropriate time period

in the management of fatigue in cancer patients in general for CRF have shown mixed results when compared with placebo in clinical trials of patients receiving palliative care. In a recent survey of 1,000 oncologists by the National Comprehensive Cancer Network, 23%

to 33% oncologists responded that they frequently used steroids for the management of CRF at the end of life

However, these trials did not use validated outcome measures and also were not adequately powered for the assessment of CRF. To our knowledge, no double blind, randomized, placebo- controlled studies of the efficacy of steroids in CRF have been undertaken or published. This lack of knowledge provided the rationale to conduct this study for CRF in our palliative care patients who had the most severe levels of distress.
 
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