Investigating the effect of Megestrol Acetate, Omega-3, Beta_ hydroxy beta _ methyl butyrate on improving the appetite status of patients with advanced cancer.

Investigating the effect of Megestrol Acetate and Omega-3 compared to Megestrol Acetate, and Beta_ hydroxy beta_ methyl butyrate on improving the appetite status of patients with advanced cancer.

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250205064658N1

Enrollment

Registered

2025-02-26

Start date

2025-03-10

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Advanced cancer diseases.

Interventions

Intervention 1: Intervention group: Intervention 1: 21 patients take 160 mg of megestrol acetate (4 tablets of 40 mg) daily, with 2 tablets taken with breakfast and 2 tablets taken with dinner. Additi

Eligibility

Sex/Gender

All

Age

45 Years to 70 Years

Inclusion criteria

Inclusion criteria: Diagnosis of advanced cancer by an oncologist (based on TMN score and type of cancer).• Presence of anorexia with a minimum score of 3 in the symptoms section (provided that the score of 3 pertains to the options of anorexia and lack of appetite).• Minimum score of 1 in the dietary intake section.• Minimum score of 0 in the recent current weight section.• Minimum score of 0 in the activity section (minimum overall score of 4).• Patients aged 45-70 years with weight loss due to advanced cancer (weight loss of at least 2.5 kg over the past 6-8 weeks or weight loss of at least 5% over the last 6-12 months).• No use of other appetite-stimulating and weight-gaining supplements during the study.• No history of allergy to beta _hydroxy beta-methyl butyrate, omega-3, and megestrol acetate.• Willingness and consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients' refusal during the study.• Occurrence of side effects.• Development of acute liver and kidney diseases.• Development of coagulation disorders.• Non-use of Beta_hydroxy beta_metyle butyrate, omega-3, and megestrol acetate during the study.

Design outcomes

Primary

Measure	Time frame
Reduction in the PG-SGA questionnaire score and weight gain. Timepoint: At the beginning of the study (before the intervention started), 21 days and 31 days after the intervention began. Method of measurement: PG-SGA questionnaire and scale (for measuring weight changes).	—

Secondary

Measure	Time frame
PG_SGA questionnaire score and weight changes. Timepoint: At the beginning of the study (before the intervention began), day 21 and day 31. Method of measurement: PG_SGA questionnaire, which consists of 4 sections.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Kharazmkia

Khoram-Abad University of Medical Sciences

kharazmkia@gmail.com+98 66 3330 0661

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026