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.
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.
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.
Parallel
Megestrol Acetate
DrugOral megestrol acetate at 625 mg/day is given from the beginning to the end of neoadjuvant chemotherapy.
Incidence of weight loss
the rate of weight loss
Appetite assessment
Questionnaire to assess appetite of patients based on the FAACT-A/CS(Functional Assessment of Anorexia/ Cachexia Therapy) scale. A total score of more than 37 indicates a good appetite. A total score of 37 or less suggests loss of appetite, with lower scores indicating more severe anorexia.
Changes in nutritional indicators
Nutritional indicators including serum albumin and pre-albumin
Quality of life assessment
questionnaire to assess quality of life based on the EORTC(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) QLQ-C30 scale，ranged from 0 to 100. The higher the patient's score, the better their quality of life.
AEs related to NCT
Incidence of adverse events related to neoadjuvant chemotherapy
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