CTRI/2018/08/015222
Completed
Phase 3
Phase 3 randomised controlled trial comparing the effectiveness of dexamethasone in reducing cancer associated fatigue in patients on palliative chemotherapy.
Cancer Institute0 sites126 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C348- Malignant neoplasm of overlappingsites of bronchus and lung
- Sponsor
- Cancer Institute
- Enrollment
- 126
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients above 18 years and less than 60 years of age
- •2\. Diagnosed with advanced breast or lung cancer and planned for palliative intravenous chemotherapy.
- •3\. Not received chemotherapy in the preceding one month.
- •4\. ECOG performance score of less than or equal to 2\.
- •5\. Normal cognition.
- •6\. No contraindications to steroids.
- •7\. Absence of active infection
- •8\. Signed informed consent.
Exclusion Criteria
- •1\. History of diabetes mellitus or hypertension.
- •2\. Past history of peptic ulcer or gastrointestinal bleed.
- •3\. Congestive heart failure and ischemic heart disease.
- •4\. Diseases like brain tumors and prostate cancer were corticosteroids are part of the treatment. Use of corticosteroids as anti\-emetic is permitted.
- •5\. Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
- •6\.Renal failure, hepatic failure, glaucoma, epilepsy.
- •7\. HIV, HBV or HCV positive
Outcomes
Primary Outcomes
Not specified
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