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New hope for cancer patients: drug may prevent chemo weight loss

NCT ID NCT06998758

Symptom relief Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether megestrol acetate, a drug that boosts appetite, can help patients with locally advanced colorectal cancer avoid weight loss during chemotherapy. About 60 adults will receive either the drug or a placebo alongside their standard treatment. The goal is to see if it improves appetite, nutrition, and treatment tolerance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal carcinoma Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoadjuvant chemotherapy Weight loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Sixth Affiliated Hospital of Sun-Yat sen University

    RECRUITING

    Guangzhou, Guangdong, 510065, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.