Advanced stage cancer who will receive chemotherapy treatment Olanzapine, weight gain, quality of life, anorexia,
Conditions
Interventions
Placebo 5 mg oral hs OD duration 12 week ,olanzapine 2.5 mg po hs OD duration 12 week ,olanzapine 5mg po hs OD duration 12 week
Sponsors
Rajavithi hospital, Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Advanced stage cancer who will receive chemotherapy treatment 2. Age>= 18 years 3. ECOG 0-2 4. Life expectancy > 3 months 5. Sign inform consent
Exclusion criteria
Exclusion criteria: 1. Concurrent chemoradiation 2. Receiving other antidepressants or antipsychosis 3. NG, NJ tube insertion 4. Corticosteroids treatment more than 1 months 5. Megestrol acetate treatment 6. Pregnancy or breastfeeding 7. Olanzapine allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight gain 10 percent Group B and 15.0 percent in Group A , yielding a risk ratio of 2.00, P 0.455. 30 percent Group C and 15.0 percent in Group A , yielding a risk ratio of 0.67, P 0.268. 12 weeks weight change measurement kilogram record by Saint Med super smart society 5.0 machine by patient self-standing then recording by nurse aid | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life improvements in global health status from baseline were observed in both Groups A and C, while Group B exhibited minimal change 12 weeks EORTC QLQ-C30,Appetite: VAS score from baseline to Week 12, was not significantly different between the olanzapine groups and the placebo group, no patients in any group achieved a FAACT A-CS score greater than 37 12 weeks VAS scale less than 70 percent interpreted as indicative of reduced appetite and FAACT A/CS A score of less than 37 was considered the optimal cut-off point for identifying anorexia,Changes in mean body weight trend toward weight gain in Group C, whereas both the placebo group A and group B exhibited slight weight loss 12 weeks weight change measurement kilogram record by Saint Med super smart society 5.0 machine by patient self-standing then recording by nurse aid,Sarcopenia was present in 55.0% of patients at baseline. By the end of treatment, Group C demonstrated a declining trend in sarcopenia prevalence 12 weeks Measurements were performed by blinded nurses using a flexible measuring tape; mean calf circumference less than 34 cm in males and less than 33 cm in females ,severely malnourished at baseline was 10.0% in Group A, 20.0% in Group B, and 15.0% in Group C 12 weeks Nutritional status, assessed using the Patient-Generated Subjective Global Assessment (PG-SGA) | — |
Countries
Thailand
Contacts
Public ContactNuttawut Kamolrat
Rajavithi hospital
Outcome results
None listed