A Phase 2 interventional study of MitoQ (mitoquinol mesylate) in Cancer Cachexia (CC) and Cancer Patients With Solid Tumors, sponsored by The First Affiliated Hospital of Xinxiang Medical College. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by The First Affiliated Hospital of Xinxiang Medical College · Phase 2, Interventional, and Treatment
Muscle strength was evaluated in subjects with malignant solid tumors and cachexia after 12 weeks of oral MitoQ treatment.
Primary Efficacy Endpoint:
To evaluate the preliminary efficacy of MitoQ in patients with cancer cachexia by comparing muscle function before and after MitoQ administration at Weeks 7 and 13, as assessed by handgrip strength and the 6-minute walk test (6MWT).
Key Secondary Efficacy Endpoints:
Inflammatory and Metabolic Markers: Changes in the levels of C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α); effects on oxidative stress markers (MDA, SOD, GPx); and levels of prealbumin and serum albumin.
Clinical Benefit Endpoints:
Changes in skeletal muscle mass at Weeks 7 and 13, as measured by the skeletal muscle index (SMI) at the third lumbar vertebra (L3) level using computed tomography (CT), as well as changes in body weight, including total body weight, fat mass, and lean body mass.
Quality of life and symptom assessment using validated instruments: the EORTC QLQ-C30 (quality of life), the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), the Hospital Anxiety and Depression Scale (HADS), and the Cancer Fatigue Scale (CFS).
Other Secondary Efficacy Endpoints:
Tumor Response and Survival Endpoints: Objective response rate (ORR) based on RECIST version 1.1 criteria and progression-free survival (PFS).
Safety Assessment: Hepatic function tests and lipid profile. Exploratory Endpoints: Exploratory biomarkers including metabolic and inflammatory factors.
Safety Endpoints:
Vital signs, physical examination, laboratory parameters, electrocardiogram (ECG), echocardiography, and adverse events (AEs), with AEs graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's planned enrollment of 20 is below the median of 74 across 226 interventional studies indexed under Cachexia.
Browse Cachexia studies →The First Affiliated Hospital of Xinxiang Medical College is the lead sponsor of 42 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects aged ≥ 18 years at the time of screening. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.
Ability to sign the form. (ECOG) performance status of 0, 1, or 2. of more than 3 months. Patients with or cytologically confirmed malignant solid tumors (patients with hepatocellular carcinoma may be enrolled based on clinical diagnosis).
Medically documented cachexia or pre-cachexia (patient-reported weight loss data are acceptable for patients receiving treatment):
Cachexia: Involuntary weight loss of >5% within 6 months prior to screening. Pre-cachexia: Involuntary weight loss of ≤5% within 6 months prior to screening, accompanied by anorexia or metabolic alterations.
Adequate organ function, as defined by the following:
Serum total ≤ 1.5 × (ULN), unless the subject has a confirmed diagnosis of Gilbert's syndrome.
(AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; if tumor involves the liver, ≤ 5.0 × ULN.
Creatinine ≤ 2 mg/dL, or (GFR) ≥ 30 mL/min/1.73 m², calculated according to the Modification of Diet in Renal Disease (MDRD) formula.
Subjects of must agree to use at least one medically acceptable and effective method of during sexual intercourse throughout the study period and for 6 months after the last dose of study drug, and must have no plans for pregnancy or sperm/egg donation.
Subjects who clearly understand the study, voluntarily agree to participate, and sign the informed consent form personally.
Exclusion Criteria:
Known to MitoQ capsules or any of the . Subjects with known symptomatic requiring regular use of . Asymptomatic or previously diagnosed brain metastases may be included if the following conditions are met: treatment has been completed, and the subject has recovered from acute effects of radiation therapy or surgery prior to screening; corticosteroid therapy for brain metastases has been discontinued, and the neurological status is stable prior to the first dose of study drug.
Known active virus (HBV) or virus (HCV) infection (subjects with HBV-DNA \< 10⁴ IU/mL may be enrolled).
Known positive test for (HIV) or positive treponemal antibody (TP-Ab) test.
Currently existing reversible reduction in food intake, as determined by the investigator, including but not limited to:
National Cancer Institute (NCI) (CTCAE) Grade 3 or 4 oral mucositis; NCI CTCAE Grade 3 or 4 gastrointestinal (GI) disorders (e.g., nausea, vomiting, diarrhea, and constipation); Mechanical obstruction preventing oral intake. Receiving tube feeding or parenteral nutrition (whether total or partial parenteral nutrition) at the time of screening.
Major surgery within 4 weeks prior to the first dose of study drug (central venous access device placement and tumor are not considered major surgery); subjects must have adequately recovered from the acute effects of surgery prior to screening, and no major surgery should be planned during the study period.
Severe gastrointestinal disorders (including esophagitis, gastritis, and malabsorption).
History of subtotal gastrectomy or small bowel resection (more than one-third).
Cachexia caused by other conditions, as determined by the investigator, including but not limited to:
Severe (COPD); (NYHA) Class III or IV heart failure; Acquired immunodeficiency syndrome (AIDS). Any of the following events within the past 3 months: myocardial infarction, congenital long syndrome, torsades de pointes, cardiac arrhythmia (including sustained ventricular tachycardia and ventricular fibrillation), unstable angina, coronary artery or peripheral artery bypass graft, symptomatic congestive heart failure (CHF, NYHA Class III or IV), severe cerebrovascular accident, or symptomatic pulmonary embolism or other cardiovascular/thromboembolic disease.
Persistent malignant arrhythmia of NCI CTCAE Grade ≥ 2. Initiation of new systemic corticosteroid therapy within 4 weeks prior to the first dose of study drug. Stable corticosteroid therapy (i.e., no significant change in dose or frequency of administration within 4 weeks prior to the first dose) is permitted, such as dexamethasone used as a premedication or daily oral prednisone.
Planned anti-tumor therapy during the study that includes agents known to cause weight gain, such as ALK inhibitors, ROS1 inhibitors, or docetaxel, within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug.
Use of any prescription medication that increases appetite or ameliorates weight loss within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug, including but not limited to anamorelin, medroxyprogesterone acetate, dronabinol, medical cannabis, etc.
Currently receiving another drug, or use of another investigational drug within 4 weeks prior to the first dose of study drug or within 5 half-lives of the previous investigational drug (whichever is longer).
Female subjects who are pregnant or breastfeeding. Any other acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormalities that may increase the risk associated with study participation or use of the study drug, or that may interfere with the interpretation of study results. The investigator may exclude a subject from participation if, in the investigator's judgment, the subject is unsuitable for enrollment in this study for any of these reasons.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MitoQ 20 mg/day (one 20 mg capsule), administered orally once daily in the morning on an empty stomach.
Dietary Supplement: MitoQ (mitoquinol mesylate)
MitoQ 20 mg/day (one 20 mg capsule), administered orally once daily in the morning on an empty stomach.
To evaluate the preliminary efficacy of MitoQ in patients with cancer cachexia
To evaluate the preliminary efficacy of MitoQ in patients with cancer cachexia by comparing muscle function before and after MitoQ administration at Weeks 13, as assessed by handgrip strength.
Time frame: 0-13 Weeks
Inflammatory and Metabolic Markers
Changes in the levels of C-reactive protein (CRP).
Time frame: 0-13 Weeks
Clinical Benefit Endpoints
Changes in skeletal muscle mass at Weeks 13, as measured by the skeletal muscle index (SMI) at the third lumbar vertebra (L3) level using computed tomography (CT).
Time frame: 0-13 Weeks
Clinical Benefit Endpoints
Quality of life and symptom assessment using validated instruments: the EORTC QLQ-C30 (quality of life).
Time frame: 0-13 weeks
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Mitoquinone
The First Affiliated Hospital of Xinxiang Medical College