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Stage IV Gastric CancerNCT05856500

A Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors

A study testing basic nutrition and oral supplement of creatine and curcumin in people with Stage IV Gastric Cancer and Stage IIIA Gastric Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
basic nutrition and oral supplement of creatine and curcumin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
No sites listed yet
Study dates
1 Jun 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

Xiaotian Chen contact

13851752678

chenxiaotian@njglyy.com

About this study

Official title: A Prospective Open Controlled Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors

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.

Read the detailed description

This is a prospective open controlled study. The intervention is targeted at participants with early cachexia in upper gastrointestinal tumors.Both control group and intervention group receive basic nutritional support. On the basis of this, the intervention group will be given creatine and curcumin orally.The purpose is to investigate whether creatine combined with curcumin can improve the inflammatory and the nutritional state, correct the disorder of nutrient metabolism and improve the prognosis of participants.

Being tested
basic nutrition, oral supplement of creatine and curcumin
Keywords
Creatine, Cur-cumin, Early Cachexia
Medical subject headings
Stomach Neoplasms, Esophageal Neoplasms, Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • basic nutritionDietary supplement

    An adequate supply of energy and protein in diet, oral nutrition supplement or tube feeding enteral nutrition supplement when diet is deficient.

  • oral supplement of creatine and curcuminDietary supplement

    Creatine and curcumin are orally added other than basic nutrition treatment.

Study groups in NCT05856500
Study groupRoleWhat they receive
basic nutritionPlacebo comparatorbasic nutrition treatment, energy 30-35 kcal/kg, protein 1.0-2.0 g/kg, total nutrition and/or whey protein oral nutrition supplement or tube feeding enteral nutrition supplement if diet deficiency;
Receives: Dietary Supplement: basic nutrition
oral supplement of creatine and curcuminExperimentalOn the basis of basic nutrition in group A, creatine 5g/d and curcumin 4g/d are orally added, and the intervention time is 1 month.
Receives: Dietary Supplement: oral supplement of creatine and curcumin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. L3 skeletal muscle index(c㎡/㎡)

    CT scans L3 cross-sectional skeletal muscle area/height²

    Measured: 0-month

  2. L3 skeletal muscle index(c㎡/㎡)

    CT scans L3 cross-sectional skeletal muscle area/height²

    Measured: 1-month

  3. Appendicular skeletal muscle mass index(kg/㎡)

    Appendicular skeletal muscle mass(ASM)is measured by bioelectrical impedance analysis(BIA), the ASM index (ASM/height²)is calculated.

    Measured: 0-month

  4. Appendicular skeletal muscle mass index(kg/㎡)

    Appendicular skeletal muscle mass(ASM)is measured by bioelectrical impedance analysis(BIA), the ASM index (ASM/height²)is calculated.

    Measured: 1-month

Secondary outcomes (14)

  1. Pre-albumin concentration(mg/L)

    Serological pre-albumin concentration

    Measured: 0-month

  2. Pre-albumin concentration(mg/L)

    Serological pre-albumin concentration

    Measured: 1-month

  3. Albumin concentration(g/L)

    Serological albumin concentration

    Measured: 0-month

  4. Albumin concentration(g/L)

    Serological albumin concentration

    Measured: 1-month

  5. Body Mass Index(kg/㎡)

    body weight/height²

    Measured: 0-month

  6. Body Mass Index(kg/㎡)

    body weight/height²

    Measured: 1-month

  7. Nutrition intake level(%)

    Investigate the ratio of actual energy and protein intake levels to target intake levels

    Measured: 0-month

  8. Nutrition intake level(%)

    Investigate the ratio of actual energy and protein intake levels to target intake levels

    Measured: 1-month

  9. PG-SGA score

    Scored Patient-Generated Subjective Global Assessment(PG-SGA)：(0-1，stage A；2-8，stage B；≥9，stageC)

    Measured: 0-month

  10. PG-SGA score

    Scored Patient-Generated Subjective Global Assessment(PG-SGA)：(0-1，stage A；2-8，stage B；≥9，stageC)

    Measured: 1-month

  11. Functional Assessment of Anorexia/Cachexia Therapy(FAACT)

    Anorexia/Cachexia Sub-scale-12：score 0～24，Anorexia/Cachexia

    Measured: 0-month

  12. Functional Assessment of Anorexia/Cachexia Therapy(FAACT)

    Anorexia/Cachexia Sub-scale-12：score 0～24，Anorexia/Cachexia

    Measured: 1-month

  13. Survival rate(%)

    (Number of surviving cases after 1 month of follow-up)/(number of cases at the beginning of follow-up) ×100%

    Measured: 1-month

  14. Survival rate(%)

    (Number of surviving cases after 3 month of follow-up)/(number of cases at the beginning of follow-up) ×100%

    Measured: 3-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05856500
Sponsor's protocol ID
2022-223-02
Status last verified
Dec 2022
First submitted
5 Dec 2022
Last updated
18 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing basic nutrition and oral supplement of creatine and curcumin in people with Stage IV Gastric Cancer and Stage IIIA Gastric Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.

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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaotian Chen (13851752678, chenxiaotian@njglyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

L3 skeletal muscle index(c㎡/㎡) (time frame: 0-month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05856500.

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 18 May 2023.

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