Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC
Recruiting · NCT06998758 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Cancer-associated anorexia, a debilitating condition characterized by progressive appetite loss in oncology patients, contributes to pancytopenia, sarcopenia, and adipose tissue depletion. Megestrol acetate (MA) improves appetite and promotes weight gain through multiple mechanisms, playing a crucial role in the nutritional management of cancer patients. Total mesorectal excision (TME) following neoadjuvant chemotherapy has become the standard treatment strategy for patients with locally advanced colorectal cancer (LACRC). Despite its oncological benefits, neoadjuvant chemotherapy frequently induces grade ≥2 gastrointestinal toxicities (including nausea, emesis, and diarrhea) that exacerbate malnutrition through appetite suppression and negative energy balance. Previous studies have demonstrated that combining MA with first-line maintenance chemotherapy in patients with metastatic colorectal cancer significantly improves appetite, increases body weight, enhances quality of life, and improves prognosis. However, the safety and efficacy of MA during the neoadjuvant treatment phase of LACRC remain unclear. This multicenter, randomized controlled clinical trial aims to evaluate the effects of MA on chemotherapy--related weight loss, anorexia, nutritional status, and chemotherapy tolerance in patients with LACRC undergoing neoadjuvant chemotherapy. Additionally, this study will assess the safety profile of MA in this clinical setting.
Who can take part
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.
Where it is running
1 location listed.
- The Sixth Affiliated Hospital of Sun-Yat sen University - Guangzhou, Guangdong, China