A Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastroi… (NCT05856500) | Clinical Trial Compass
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A Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors
152 participantsStarted 2023-06-01
Plain-language summary
Cachexia is a common complication of various advanced malignant tumors, which seriously affects the quality of life and survival time of patients. In view of the clinical problem of non-nutritional response in patients with cachexia, the investigators plan to carry out a clinical case-control study on the intervention of creatine combined with curcumin in participants with cachexia. On the whole, the investigators limited the study subjects to upper digestive tract tumors and diagnosed participants with early cachexia. The main purpose of this study is to determine whether the combination of the two can play a positive and stable role in inhibiting the inflammation of cachexia and improving metabolic status, so that basic nutrition can play a role, in order to reduce the level of skeletal muscle consumption, maintain weight, improve quality of life, save medical costs and extend survival time.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of advanced tumors of the upper digestive tract with untreatable or postoperative recurrence of esophageal and gastric cancer III-IV
* Meet the diagnostic criteria of early cachexia (anorexia and metabolic changes, involuntary body mass reduction ≤5% within 6 months)
* Radiotherapy, chemotherapy or immunotherapy in our hospital
* Understand and fill in a variety of rating scales
* Informed consent, voluntary participation in this study
Exclusion Criteria:
* Neoadjuvant chemotherapy patients
* Intestinal obstruction or gastrointestinal bleeding
* Severe heart, lung and renal insufficiency
* Coagulopathy
* Clinical diagnosis with diabetes and other metabolic diseases
* The expected survival time is less than 1 month
* With cognitive dysfunction or poor coordination
* Allergy to creatine or curcumin
* With a history of drug abuse
* Doctors or researchers deem unsuitable for study participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
L3 skeletal muscle index(c㎡/㎡)
Timeframe: 0-month
2
L3 skeletal muscle index(c㎡/㎡)
Timeframe: 1-month
3
Appendicular skeletal muscle mass index(kg/㎡)
Timeframe: 0-month
4
Appendicular skeletal muscle mass index(kg/㎡)
Timeframe: 1-month
Trial details
NCT IDNCT05856500
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School