A Double-Blind Study Comparing Two Treatment Approaches for Cancer-Related Loss of Appetite

OMO-CAT: Olanzapine Plus Megestrol Acetate versus Olanzapine plus Placebo for Cancer -related Anorexia Treatment: A Double-blind placebo Controlled Trial - OMO-CAT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/111554

Enrollment

416

Registered

2026-06-01

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: C801- Malignant (primary) neoplasm, unspecified

Interventions

Intervention1: Olanzapineplus Megestrol Acetate: Arm B: Olanzapine 2.5mg plus Megestrol Acetate 160mg once a day for 12 weeks Control Intervention1: Olazapine plus placebo: Arm A: Oral Olanzapine 2.

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age more than 18 years at enrollment 2.ECOG Performance Status: 0 to 3 3.All Patients undergoing chemotherapy (with or without targeted therapy) for gastric, hepato-pancreatic-biliary, or lung cancer 4.Expected survival more than 3 months 5.Patients able to take orally

Exclusion criteria

Exclusion criteria: ) Receiving adjuvant chemotherapy b) Concurrent radiotherapy c) Olanzapine intake more than 4 days/month for other indications. d) On antipsychotics or antidepressants e) Use of systemic corticosteroids (greater than or equal to 5 mg prednisolone for more then 7 days in past 4 weeks) f) Ascites at time of enrollment g) Pregnant patients h) Enrolled in another trial within the past 3 months

Design outcomes

Primary

Measure	Time frame
To assess and compare the effectiveness of Olanzapine plus Megestrol Acetate (MA) versus Olanzapine alone in terms of: oBody weight gain oImprovement in anorexia-related symptoms Timepoint: Base line to 12 weeks	—

Secondary

Measure	Time frame
1 To compare additional outcomes between the two treatment groups, including: 2 Quality of Life (QoL) changes using validated tools 3 Symptom control of anorexia, Appetite and sarcopenia assessed through: a)Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT-A/CS) b)SARC-F Tool a Questionnaire c)Visual Analogue Scale (VAS) for appetite 5 Incidence of Grade 3 4 chemotherapy-related toxicities 6 Changes in Skeletal Muscle Mass, measured via L3 Skeletal Muscle Index (L3SMI) on Contrast-Enhanced CT (CECT) 7 Adverse event profile, comparing frequency and severity between the two group Timepoint: Basline to 12 weeks	—

Measure

Time frame

1 To compare additional outcomes between the two treatment groups, including: 2 Quality of Life (QoL) changes using validated tools 3 Symptom control of anorexia, Appetite and sarcopenia assessed through: a)Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT-A/CS) b)SARC-F Tool a Questionnaire c)Visual Analogue Scale (VAS) for appetite 5 Incidence of Grade 3 4 chemotherapy-related toxicities 6 Changes in Skeletal Muscle Mass, measured via L3 Skeletal Muscle Index (L3SMI) on Contrast-Enhanced CT (CECT) 7 Adverse event profile, comparing frequency and severity between the two group Timepoint: Basline to 12 weeks

—

Countries

India

Contacts

Public ContactJasleen Kaur

Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab

alokdrgoel@gmail.com09899701286

Outcome results

None listed

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