Steroid tablets for preventing tiredness in cancer patients receiving chemotherapy medicine.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C348- Malignant neoplasm of overlappingsites of bronchus and lung
- Registration Number
- CTRI/2018/08/015222
- Lead Sponsor
- Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 126
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the magnitude and extent of fatigue as measured by Symbolic Assessment of Fatigue Extent (SAFE) scale between the dexamethasone group and standard group.Timepoint: Symbolic Assessment of Fatigue Extent (SAFE) scale will be used to calculate magnitude and extent of fatigue. The SAFE scale will be administered before the initiation of chemotherapy and at the end of 6 and 12 weeks of chemotherapy. The SAFE scale will be administered by the investigators or staff from the psycho-oncology department. NCI CTCAE V4.0 grading of fatigue will also be done.
- Secondary Outcome Measures
Name Time Method To assess the difference in the incidence of adverse events between the dexamethasone group and standard group.Timepoint: Continuous daily assessment for 13 weeks since enrollment in study