Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · May 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called megestrol acetate (MA) on patients with locally advanced colorectal cancer (LACRC) who are undergoing neoadjuvant chemotherapy. Neoadjuvant chemotherapy is treatment given before surgery to shrink tumors, but it can often cause side effects like nausea and loss of appetite, leading to weight loss and malnutrition. The trial aims to find out if MA can help improve appetite, promote weight gain, and enhance the overall nutritional status of these patients during their treatment.

To participate in this trial, individuals must be between 18 and 75 years old and have been diagnosed with colorectal cancer. They should be in a specific stage of the disease and suitable for the neoadjuvant chemotherapy treatment. Participants will be monitored for changes in weight, appetite, and their ability to tolerate chemotherapy while ensuring the safety of the medication. It's important for potential participants to discuss their eligibility with their healthcare provider, especially if they have certain health conditions or have received previous chemotherapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.