Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line TreatmentNCT06830018
Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue
A study testing Nano-crystalline Megestrol Acetate Oral Suspension and Standard Treatment in people with Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for the first-line treatment of patients with cancer-related fatigue in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment
- What is being tested?
- Nano-crystalline Megestrol Acetate Oral Suspension and Standard Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2.
- Expected survival ≥ 6 months.
- Locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal adenocarcinoma not amenable to radical treatment with histologic or cytologic confirmation.
- No prior systemic systemic antitumor therapy for gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal cancer.
- Have at least one measurable tumor lesion according to RECIST v1.1.
Show all 9Show fewer
- Compliance with a Fatigue Visual Analog Scale (VAS) score of ≥ 4 (consistent with moderate or severe fatigue).
- Complain of anorexia.
- Good organ function as determined by the following requirements.
Who cannot join
- Suffered significant surgery or traumatic injuries within the past 1month.
- Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting.
- currently undergoing tube feeding or parenteral nutrition.
- Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain.
- Received erythropoietin or blood transfusion within the past 1month.
- Comorbidities such as serious cerebrovascular, heart, kidney, or liver disease.
- A history of hypersensitivity to the components of the trial medication.
- Other conditions that were considered inappropriate as determined by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital Of China Medical University
Shenyang, Liaoning, 110000
About this study
Official title: A Multicenter, Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment Alone for the First-line Treatment of Patients With Cancer-related Fatigue In Gastric Or Colorectal Cancer
This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for the first-line treatment of patients with cancer-related fatigue in gastric or colorectal cancer.
- Being tested
- Nano-crystalline Megestrol Acetate Oral Suspension, Standard Treatment
- Keywords
- cancer-related fatigue， cancer-caused fatigue，fatigue，appetite stimulants, gastric cancer，colorectal cancer，gastrointestinal tumor，cancer，tumor，carcinoma，, nano-crystalline megestrol acetate，megestrol，megestrol acetate，, antineoplastic agents, hormonal，central nervous system stimulants，appetite stimulants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-crystalline Megestrol Acetate Oral SuspensionDrug
Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication; after completing the treatment cycle, patients who are assessed by the researchers as suitable for continued treatment may continue to receive therapy.
Standard TreatmentCombination product
Standard Treatment，First-line treatment (chemotherapy + immunotherapy/targeted therapy)
| Study group | Role | What they receive |
|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy | Experimental | Not described Receives: Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Combination Product: Standard Treatment |
| Standard Therapy | Active comparator | Not described Receives: Combination Product: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV).
Measured: week 6
the difference in improvement of appetite based on A/CS-12 assessment
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start23 Jan 2025
- Primary completionJan 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line TreatmentStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830018
- Sponsor's protocol ID
- MGA- Fatigue-01
- Status last verified
- Jan 2025
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment Alone for the First-line Treatment of Patients With Cancer-related Fatigue In Gastric Or Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06830018
- Acronym / sponsor ID
- MGA- Fatigue-01
- Keywords
- cancer-related fatigue， cancer-caused fatigue，fatigue，appetite stimulants, gastric cancer，colorectal cancer，gastrointestinal tumor，cancer，tumor，carcinoma，, nano-crystalline megestrol acetate，megestrol，megestrol acetate，, antineoplastic agents, hormonal，central nervous system stimulants，appetite stimulants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for the first-line treatment of patients with cancer-related fatigue in gastric or colorectal cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy | Experimental | Drug: Nano-crystalline Megestrol Acetate Oral Suspension, Combination Product: Standard Treatment |
| Standard Therapy | Active comparator | Combination Product: Standard Treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2.
- Expected survival ≥ 6 months.
- Locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal adenocarcinoma not amenable to radical treatment with histologic or cytologic confirmation.
- No prior systemic systemic antitumor therapy for gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal cancer.
Key exclusion criteria (8 listed)
- Suffered significant surgery or traumatic injuries within the past 1month.
- Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting.
- currently undergoing tube feeding or parenteral nutrition.
- Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain.
- Received erythropoietin or blood transfusion within the past 1month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano-crystalline Megestrol Acetate Oral SuspensionNano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication; after completing the treatment cycle, patients who are assessed by the researchers as suitable for continued treatment may continue to receive therapy. | Drug | Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy |
| Standard TreatmentStandard Treatment，First-line treatment (chemotherapy + immunotherapy/targeted therapy) | Combination product | Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy, Standard Therapy |
Primary outcome
the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV).
Time frame: week 6
the difference in improvement of appetite based on A/CS-12 assessment
Time frame: week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano-crystalline Megestrol Acetate Oral Suspension and Standard Treatment in people with Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiujuan Qu (024-83281560, xjqu@cmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV). (time frame: week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.