Status:
RECRUITING
Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Neoadjuvant Chemotherapy
Weight Loss
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Cancer-associated anorexia, a debilitating condition characterized by progressive appetite loss in oncology patients, contributes to pancytopenia, sarcopenia, and adipose tissue depletion. Megestrol a...
Detailed Description
This clinical trial is an open-label, prospective, multicenter, randomized study. The aims of this study are to evaluate the effects of megestrol acetate (MA) on ameliorating neoadjuvant chemotherapy-...
Eligibility Criteria
Inclusion
- Adult males and females aged between 18 and 75 years old.
- Histologically confirmed colorectal adenocarcinoma.
- Immunohistochemistry showing pMMR or MSI status determined as MSS.
- Clinical stage cTxN1-2M0, with or without MRF positivity, and with or without EMVI positivity.
- ECOG performance status 0-1, with a life expectancy of ≥6 months.
- Deemed suitable for preoperative mFOLFOX6 neoadjuvant chemotherapy following multidisciplinary team discussion.
- Written informed consent has been obtained from the patients.
Exclusion
- Patients with cardiac arrhythmias requiring anti-arrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the past 6 months), or congestive heart failure greater than NYHA Class II.
- Patients with poorly controlled severe hypertension.
- Patients with a history of HIV infection or active chronic hepatitis B or C (with high-copy viral DNA).
- Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.
- Patients with other active severe clinical infections (per NCI-CTC v.5.0).
- Patients who have previously received chemotherapy.
- Patients with a history of seizures requiring treatment (e.g., steroids or anti-epileptic therapy).
- Patients with drug abuse or medical, psychological, or social conditions that may interfere with study participation or outcome assessment.
- Patients with a known or suspected allergy to the study drug or any agents administered in relation to the trial.
- Patients with any unstable condition that may jeopardize patient safety or compliance.
- Pregnant or breastfeeding women, or fertile women not using adequate contraception.
- Patients who refuse to sign the informed consent form.
Key Trial Info
Start Date :
November 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06998758
Start Date
November 11 2025
End Date
December 31 2028
Last Update
December 12 2025
Active Locations (1)
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1
The Sixth Affiliated Hospital of Sun-Yat sen University
Guangzhou, Guangdong, China, 510065