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An open-label, randomized control trial to Determine the optimal dose of megestrol acetate in advance stage cancer patients having anorexia cachexia syndrome.

An open-label,phase III randomized control trial to observe the weight gain and appetite improvement with use of Megestrol in advanced stage cancer patients having anorexia and cachexia syndrome - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084037
Enrollment
280
Registered
2025-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: - Health Condition 2: C00-D49- Neoplasms

Interventions

Intervention1: MEGESTROL: To compare the safety and efficacy weight gain and appetite improvement of megestrol when given in two doses160mg per day Control Intervention1: MEGESTROL: To compare the saf

Sponsors

Tata Memorial centre Administrative Research Council
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients with 18 years and above 2 Advance Stage Patients with confirmed diagnosis of ACS 3 Loss of Greater than 5 Percent pre illness of body weight in the previous 3 months 4 Life expectancy of Greater or Equal to 4 months 5 Patients receiving palliative treatment or supportive care

Exclusion criteria

Exclusion criteria: 1 Patient with history of hypertension and diabetes mellitus 2 Mechanical obstruction to feeding 3 Pregnant women or breast-feeding women 4 History of thromboembolism and edema 5 Patients already on alternative medications that may significantly show improvement in weight gain 6 Patients refuse to consent

Design outcomes

Primary

MeasureTime frame
Primary outcome 1. To compare weight and appetite improvement in participants in both arms. Secondary Outcome ââ?¬â?? 1. To compare quality of life at baseline and 4 weekly till the primary endpoint. 2. To compare adverse events in both arms.Timepoint: 12weeks

Secondary

MeasureTime frame
Secondary Outcome ââ?¬â?? 1. To compare quality of life at baseline and 4 weekly till the primary endpoint. 2. To compare adverse events in both arms.Timepoint: 12weeks

Countries

India

Contacts

Public ContactDr Kunal Ranjan Vinayak

HBCH AND MPMMCC Varanasi

kunal@mpmmcc.tmc.gov.in8828362082

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026