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Gastric CancerENERGYNCT05959226

Effect of Exercise and Enteral Nutrition on Survival

A study testing Exercise Intervention and Nutrition Intervention in people with Gastric Cancer and Nutrition Related Cancer, run by The First Hospital of Jilin University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The present clinical trial was designed to explore the effect of postoperative physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Exercise Intervention and Nutrition Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
960 participants
Where
No sites listed yet
Study dates
1 Aug 2023to 1 Aug 2028
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Patients diagnosed with distant metastasis through abdominal lung CT/MRI or PET-CT
  • Pregnant or lactating women
  • People with uncontrolled epilepsy, Central nervous system disease or mental disorders
  • Patients with combined limb disabilities or motor dysfunction;
  • Patients with other malignant diseases in the past five years, excluding cured skin cancer and cervical Carcinoma in situ
  • Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction within the past 6 months
Show all 13Show fewer
  • Have a history of cerebral infarction or cerebral hemorrhage in the past 6 months
  • Organ transplantation requires immunosuppressive therapy
  • Serious uncontrolled recurrent infections or other serious uncontrolled concomitant diseases
  • The patient has complications of Grade III or above in Clavien Dindo classification or has been hospitalized for more than 14 days after surgery due to various reasons;
  • Urgent surgery required due to tumor emergencies (bleeding, perforation, obstruction)
  • Pulmonary function test FEV1<expected value 50%
  • Received radiotherapy, chemotherapy, or other neoadjuvant treatment before surgery

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mingjie Xia, Dr contact

86-431-81875601

xmj1983@jlu.edu.cn

About this study

Official title: Effect of Exercise and Enteral Nutrition Intervention on Survival in Patients With Locally Advanced Gastric Cancer: a Prospective Multicenter Randomized Controlled Study

The present clinical trial was designed to explore the effect of postoperative physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer.

Read the detailed description

The present clinical trial was designed to explore the effect of physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer. In the trial group, comprehensive postoperative management model with targeted exercise intervention and nutritional support. The details are as follows:

  1. Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of enteral nutrition supplement (ONS) in addition to their normal diet. Once the patient's oral diet decreases, ONS will be added several times a day to ensure that the total energy reaches the ESPEN recommended daily 30 kcal/kg. The daily protein requirement is set at 1.2-1.5 g/kg of actual body weight. The Dietitian will keep records and help patients adjust their energy intake weekly.
  2. Exercise: under the guidance of the rehabilitation therapist, the patient gradually recovers Exercise from discharge (7-14 days after the operation) to 6 months after the operation, and should ensure at least 150 minutes of moderate intensity exercise or a combination of equivalent activities per week; The control group patients received the same baseline evaluation as the experimental group patients. The control group will not receive phisical exercise intervention, but will receive postoperative nutritional treatment with the same standards as the experimental group.
Being tested
Exercise Intervention, Nutrition Intervention
Medical subject headings
Stomach Neoplasms, Sarcopenia

What participants receive

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

  • Exercise InterventionBehavioural

    1. Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of oral nutrition supplement (ONS) in addition to their normal diet..
    2. Exercise: under the guidance of the rehabilitation therapist, the patient gradually recovers Exercise from discharge (7-14 days after the operation) to 6 months after the operation, and should ensure at least 150 minutes of moderate intensity exercise or a combination of equivalent activities per week;

  • Nutrition InterventionDietary supplement

    (1) Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of oral nutrition supplement (ONS) in addition to their normal diet..

Study groups in NCT05959226
Study groupRoleWhat they receive
Exercise and Enteral Nutrition InterventionExperimentalA comprehensive postoperative management combined physical exercise intervention with oral nutritional support
Receives: Behavioral: Exercise Intervention; Dietary Supplement: Nutrition Intervention
Enteral Nutrition InterventionActive comparatorThe control group will not receive exercise intervention, but will receive postoperative nutritional support treatment with the same standards as the experimental group.
Receives: Dietary Supplement: Nutrition Intervention

What is being measured

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

  1. 3-year overall survival rate

    The 3-year overall survival rate refers to the proportion of gastric cancer patients who have survived for more than 3 years after various comprehensive treatments

    Measured: 3 years after surgery

Secondary outcomes (3)

  1. 3-year disease-free survival rate

    The proportion of clinically confirmed complete remission to recurrence within 3 years

    Measured: 3 years after surgery

  2. Scored Patient-Generated Subjective Global Assessment, PG-SGA

    Scored Patient-Generated Subjective Global Assessment is the preferred method recommended by the American Dietitian Association for nutritional screening of tumor patients. It can conduct qualitative and quantitative comprehensive evaluation of patients' nutritional status from four aspects: weight loss, disease and age, metabolic stress status, and physical examination. It is a sensitive evaluation scale for patients to malnutrition changes

    Measured: 6 months after surgery

  3. QLQ-C30 assessment

    The quality of life of patients 6 months after surgery was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), which can evaluate the quality of life from a multidimensional perspective and better reflect the connotation of quality of life. It is widely used in clinical practice to measure the quality of life of cancer patients.

    Measured: 6 months after surgery

Timeline

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

  1. First posted25 Jul 2023
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2028 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
960 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05959226
Sponsor's protocol ID
STARS-GC07
Acronym
ENERGY
Status last verified
Jul 2023
First submitted
17 Jul 2023
Last updated
25 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tegels JJ, van Vugt JL, Reisinger KW, Hulsewe KW, Hoofwijk AG, Derikx JP, Stoot JH. Sarcopenia is highly prevalent in patients undergoing surgery for gastric cancer but not associated with worse outcomes. J Surg Oncol. 2015 Sep;112(4):403-7. doi: 10.1002/jso.24015. Epub 2015 Aug 31.

    PubMed 26331988

  • Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.

    PubMed 31135850

  • Davis JL, Selby LV, Chou JF, Schattner M, Ilson DH, Capanu M, Brennan MF, Coit DG, Strong VE. Patterns and Predictors of Weight Loss After Gastrectomy for Cancer. Ann Surg Oncol. 2016 May;23(5):1639-45. doi: 10.1245/s10434-015-5065-3. Epub 2016 Jan 5.

    PubMed 26732274

  • Climent M, Munarriz M, Blazeby JM, Dorcaratto D, Ramon JM, Carrera MJ, Fontane L, Grande L, Pera M. Weight loss and quality of life in patients surviving 2 years after gastric cancer resection. Eur J Surg Oncol. 2017 Jul;43(7):1337-1343. doi: 10.1016/j.ejso.2017.01.239. Epub 2017 Feb 9.

    PubMed 28222970

  • Aoyama T, Sato T, Maezawa Y, Kano K, Hayashi T, Yamada T, Yukawa N, Oshima T, Rino Y, Masuda M, Ogata T, Cho H, Yoshikawa T. Postoperative weight loss leads to poor survival through poor S-1 efficacy in patients with stage II/III gastric cancer. Int J Clin Oncol. 2017 Jun;22(3):476-483. doi: 10.1007/s10147-017-1089-y. Epub 2017 Feb 7.

    PubMed 28176023

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Intervention and Nutrition Intervention in people with Gastric Cancer and Nutrition Related Cancer, run by The First Hospital of Jilin University.

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 0 inclusion and 13 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: opening soon, as of the sponsor's last update on 25 Jul 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. 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 Mingjie Xia, Dr (86-431-81875601, xmj1983@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year overall survival rate (time frame: 3 years after surgery). 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 NCT05959226, which also lists 5 linked publications.

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 25 Jul 2023.

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