Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: Dexamethasone: Dexamethasone 8 mg per oral twice a day for 7 days along with physical activity.
Physical activity will consist of:
Aerobic exercises
Resistance exercises
Control Inter
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age > 18 years 2.Patient has been diagnosed with malignancy 3.Patient is planned for therapy with palliative intent 4.Patient has a fatigue score of � 4/10 on a numerical scale
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity to dexamethasone 2. Any contraindication to physical activity 3. Current, active peptic ulcer disease 4. Excessive lytic bone metastases in weight-bearing bones, which in the opinion of the investigator may be at risk for fracture 5. Uncontrolled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: To explore the efficacy of the combination of dexamethasone with physical activity versus standard care on cancer-related fatigue, by assessing the change in the FACIT-Fatigue subscale from baseline to Day 8.Timepoint: from baseline to day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: 1. To explore the efficacy of dexamethasone with physical activity versus standard care on cancer-related fatigue, by assessing change in FACIT-Fatigue subscale from baseline to Day 29 2. To assess changes in Fatigue measured by various scales, including the FACIT-F, ESAS, and MFI from baseline to Day 8, and from baseline to Day 29 between the interventional arm and the standard arm 3. To assess the change in individual symptoms as assessed by ESAS from baseline to Day 8, and from baseline to Day 29 between the two arms 4. To assess the change in sleep quality as measured on PSQI from baseline to Day 8, and from baseline to Day 29 between the two arms 5. To assess the difference in QoL from baseline to Day 8, and from baseline to Day 29 between the two arms 6. To describe the adverse effects of dexamethasone in patients with advanced cancer with CRF 7. To evaluate the PFS and OS in two armsTimepoint: 1. Baseline and Day 29 2. baseline to Day 8, and from baseline to Day 29 3. baseline to Day 8, and from baseline to Day 29 4. baseline to Day 8, and from baseline to Day 29 5.baseline to Day 8, and from baseline to Day 29 6. at every visit 7. at progression | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Centre
Outcome results
None listed