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New treatment option for Cancer-related Fatigue， Gastric Cancer，Colorectal...
Official title Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue
ClinicalTrials.gov ID: NCT06830018
What this study is testing
What is Nano-crystalline Megestrol Acetate Oral Suspension?
Nano-crystalline Megestrol Acetate Oral Suspension is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cancer-related fatigue， gastric cancer，colorectal cancer，nano-crystalline megestrol acetate，megestrol acetate，first-line treatment.
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
- 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.
- 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
- 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...
- No prior systemic systemic antitumor therapy for gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal cancer.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Shenyang, Liaoning, 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.