NCT06998758 Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC
| NCT ID | NCT06998758 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Condition | Neoadjuvant Chemotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-11-11 |
| Primary Completion | 2027-05-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2025-11-11 with a primary completion date of 2027-05-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Jun Huang, PhD.
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT06998758 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Neoadjuvant Chemotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06998758 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT06998758 currently recruiting?
Yes, NCT06998758 is actively recruiting participants. Contact the research team at huangj97@mail.sysu.edu.cn for enrollment information.
Where is the NCT06998758 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06998758 clinical trial?
NCT06998758 is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. The principal investigator is Jun Huang, PhD. at Sun Yat-sen University. The trial plans to enroll 60 participants.