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New treatment option for Neoadjuvant Chemotherapy
Official title Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC
ClinicalTrials.gov ID: NCT06998758
What this study is testing
What is Megestrol Acetate?
Megestrol Acetate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neoadjuvant chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- Patients with cardiac arrhythmias requiring anti-arrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease or...
- 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...
- Patients with other active severe clinical infections (per NCI-CTC v.5.0).
- Patients who have previously received chemotherapy.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.