A study comparing Olanzapine plus low dose Megestrol acetate with Olanzapine alone for improving weight loss and appetite in patients with cancer cachexia

Role of Olanzapine 5 mg and Low dose Megestrol Acetate 200 mg versus Olanzapine 5 mg Alone for Weight Gain and Reversal of Cancer Cachexia - A Randomised Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112158

Enrollment

Registered

2026-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 2: C15-C26- Malignant neoplasms of digestive organs Health Condition 3: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs Health Condition 4: C40-C41- Malignant neoplasms of bone and articular cartilage Health Condition 5: C50-C50- Malignant neoplasms of breast Health Condition 6: C51-C58- Malignant neoplasms of female genital organs Health Condition 7: C60-C63- Malignant neoplasm

Interventions

Intervention1: Olanzapine: Olanzapine 5mg once a day for 2 months Control Intervention1: Megestrol Acetate: Olanzapine 5mg and Megestrol Acetate 200mg once a day for 2 months

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults of age more than 18 years with histologically proven advanced solid malignancy 2. Documented unintentional weight loss of more than 5 percent in past 6 months 3. ECOG Performance Status 0 to 2

Exclusion criteria

Exclusion criteria: 1. Uncontrolled diabetes mellitus 2. CNS metastases 3. Major psychiatric illness 4. Concurrent use of other appetite stimulants

Design outcomes

Primary

Measure	Time frame
Change in body weight (kg) from baseline to 8 weeksTimepoint: 8 weeks	—

Secondary

Measure	Time frame
- Percent weight change. - Change in lean body mass. - Proportion of patients with more than or equal to 2 percent weight gain. - Appetite change (VAS score). - Safety and adverse events. - Exploratory biomarkers: serum albumin, CRP.Timepoint: 8 weeks	—

Countries

India

Contacts

Public ContactDr NAGARAJU VENKAT NIVEDITHA

KRISHNA INSTITUTE OF MEDICAL SCIENCES

askdrnarender@gmail.com7207431813

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026