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Stomach NeoplasmsNCT07183358

Family-Supervised Prehabilitation to Reduce Postoperative Complications After Neoadjuvant Chemotherapy in Gastric Cancer

A study testing Family-supervised Multimodal Prehabilitation in people with Stomach Neoplasms and Neoadjuvant Therapy, run by The Affiliated Hospital of Qingdao University at 1 site in China.

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

This study evaluates whether a family-supervised exercise-nutrition-psychology program can reduce complications after stomach-cancer surgery. Eligible patients are adults who will receive chemotherapy before surgery. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stomach Neoplasms, Neoadjuvant Therapy
What is being tested?
Family-supervised Multimodal Prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
20 Sep 2025to 20 Jun 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 years
  • Histologically proven gastric adenocarcinoma by gastroscopy
  • Clinical stage T2-4a, N any, M0 planned for neoadjuvant chemotherapy plus radical gastrectomy
  • ECOG performance status 0-1; ASA class I-III
  • Able to understand the study and provide signed informed consent

Who cannot join

  • Previous or concurrent malignancies
  • Emergent conditions (bleeding, perforation, obstruction) requiring immediate surgery
  • Pregnant or lactating women
  • Severe psychiatric disorders
  • Prior major abdominal surgery (except laparoscopic cholecystectomy)
  • Unstable angina, myocardial infarction, or cerebrovascular event within 6 months
Show all 10Show fewer
  • Continuous use of NSAIDs, corticosteroids, or probiotics within 1 month
  • Simultaneous surgery for other diseases
  • FEV1 < 50 % predicted
  • Any condition that, in the investigator's opinion, contraindicates participation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanbing Zhou contact

+86532-82911847

zhouyanbing999@aliyun.com

Yuanze Wei contact

+8619861122261

weiyuanze4385@126.com

China1 site

  • Qingdao University Affiliated Hospital

    Qingdao, Shandong, 266003

    Yanbing Zhou, +8653282911847, zhouyanbing999@aliyun.com

    Yuanze Wei, +8619861122261, weiyuanze4385@126.com

Other trials in China

About this study

Official title: Effect of Family-Supervised Multimodal Prehabilitation Throughout Preoperative Neoadjuvant Chemotherapy on Clinical Outcomes in Gastric Cancer Patients: A Single-Center Randomized Controlled Trial

This study evaluates whether a family-supervised exercise-nutrition-psychology program can reduce complications after stomach-cancer surgery. Eligible patients are adults who will receive chemotherapy before surgery. Participants are randomly assigned to either the multimodal prehabilitation program plus usual care or usual care alone. The main outcome is the rate of serious complications within 30 days after surgery. Potential benefits include fewer complications and faster recovery; risks are minimal and mainly related to mild exercise fatigue.

Being tested
Family-supervised Multimodal Prehabilitation, Standard Care
Keywords
prehabilitation, postoperative complications, multimodal, family-supervised, gastric cancer
Medical subject headings
Stomach Neoplasms, Postoperative Complications

What participants receive

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

  • Family-supervised Multimodal PrehabilitationBehavioural

    A comprehensive prehabilitation program initiated at the start of neoadjuvant chemotherapy and continued until the day before surgery. The intervention includes:

    1. Nutritional support: individualized dietary counseling and supplementation plans supervised by clinical nutritionists;
    2. Exercise training: home-based aerobic and resistance exercises monitored via wearable devices and weekly video/phone follow-ups;
    3. Psychological support: structured counseling sessions to reduce anxiety, improve treatment adherence, and enhance quality of life.

    Family members are trained to assist with supervision and compliance. The total duration is approximately 10-16 weeks, depending on the chemotherapy schedule.

  • Standard CareOther

    Standard neoadjuvant chemotherapy followed by radical gastrectomy with standard ERAS-based perioperative management, without any additional prehabilitation intervention. Participants receive routine nutritional, nursing and medical care according to hospital guidelines. The aim is to maintain current clinical practice as the control condition for comparison with the experimental prehabilitation program.

Study groups in NCT07183358
Study groupRoleWhat they receive
Control Group (Standard Care Only)Active comparatorParticipants in this arm will receive standard neoadjuvant chemotherapy followed by radical gastrectomy, along with standard ERAS (Enhanced Recovery After Surgery) perioperative management. No prehabilitation intervention will be provided.
Receives: Other: Standard Care
Prehabilitation + Standard CareExperimentalParticipants will receive a family-supervised multimodal prehabilitation program throughout the neoadjuvant chemotherapy period until the day before surgery. The intervention includes personalized nutritional support, home-based exercise training, and psychological counseling, in addition to standard neoadjuvant chemotherapy, surgery, and ERAS management.
Receives: Behavioral: Family-supervised Multimodal Prehabilitation

What is being measured

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

  1. Incidence of postoperative complications within 30 days after surgery

    Postoperative complications include surgical site infection, anastomotic leakage, bleeding, pneumonia, urinary tract infection, and other surgery-related adverse events occurring within 30 days after radical gastrectomy.

    Measured: Within 30 days after surgery

Secondary outcomes (9)

  1. Intestinal barrier function indicators (Claudin-1, Occludin, ZO-1 expression)

    Expression levels of tight junction proteins in intestinal mucosa, measured by immunohistochemistry or Western blot.

    Measured: Baseline, before surgery, and postoperative day 7

  2. Nutritional status (serum albumin, prealbumin, transferrin, hemoglobin, body weight)

    Assessment of nutritional markers and body weight changes during treatment.

    Measured: Baseline, before surgery, and postoperative day 7

  3. Karnofsky Performance Status (KPS) score

    A standardized measure of functional ability and general health status.

    Measured: Baseline, before surgery, and postoperative day 7

  4. Intraoperative blood loss and operative time

    Total intraoperative blood loss (mL) and duration of surgery (minutes).

    Measured: Day of surgery

  5. Length of postoperative hospital stay

    Number of days from surgery to hospital discharge.

    Measured: Up to 30 days after surgery

  6. Disease-free survival (DFS) at 6 months and 1 year

    Time from surgery to recurrence or death from any cause.

    Measured: 6 months and 1 year after surgery

  7. Biological barrier: gut microbiota composition and diversity

    Fecal samples will be analyzed using 16S rRNA gene sequencing to evaluate microbial diversity and composition as indicators of the biological barrier.

    Measured: Baseline, before surgery, and postoperative day 7

  8. Chemical barrier: fecal MUC2 protein level and goblet cell density

    Fecal MUC2 concentration measured by ELISA and goblet cell density in small intestinal mucosa assessed by histopathological staining.

    Measured: Baseline, before surgery, and postoperative day 7

  9. Immune barrier: fecal sIgA level and mucosal T-cell counts (CD3⁺, CD4⁺, CD8⁺)

    Fecal secretory IgA (sIgA) measured by ELISA; mucosal CD3⁺, CD4⁺, and CD8⁺ T-cell densities evaluated by immunohistochemistry.

    Measured: Baseline, before surgery, and postoperative day 7

Timeline

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

  1. First posted19 Sep 2025
  2. Study start20 Sep 2025 (estimated)
  3. Primary completion20 Mar 2026 (estimated)
  4. Study completion20 Jun 2026 (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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07183358
Sponsor's protocol ID
QYFYEC2025-156
Status last verified
Sep 2025
First submitted
13 Sep 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Golder HJ, Papalois V. Enhanced Recovery after Surgery: History, Key Advancements and Developments in Transplant Surgery. J Clin Med. 2021 Apr 12;10(8):1634. doi: 10.3390/jcm10081634.

    PubMed 33921433

  • Fleurent-Gregoire C, Burgess N, McIsaac DI, Chevalier S, Fiore JF Jr, Carli F, Levett D, Moore J, Grocott MP, Copeland R, Edbrooke L, Engel D, Testa GD, Denehy L, Gillis C. Towards a common definition of surgical prehabilitation: a scoping review of randomised trials. Br J Anaesth. 2024 Aug;133(2):305-315. doi: 10.1016/j.bja.2024.02.035. Epub 2024 Apr 26.

    PubMed 38677949

  • Biondi A, Lirosi MC, D'Ugo D, Fico V, Ricci R, Santullo F, Rizzuto A, Cananzi FC, Persiani R. Neo-adjuvant chemo(radio)therapy in gastric cancer: Current status and future perspectives. World J Gastrointest Oncol. 2015 Dec 15;7(12):389-400. doi: 10.4251/wjgo.v7.i12.389.

    PubMed 26690252

  • Kang, Y.-K., Yook, J. H., Park, Y.-K., et al. (2019). Phase III randomized study of neoadjuvant chemotherapy (CT) with docetaxel (D), oxaliplatin (O) and S-1 (S) (DOS) followed by surgery and adjuvant S-1, vs surgery and adjuvant S-1, for resectable advanced gastric cancer (GC) (PRODIGY). Annals of Oncology, 30(10), 1637-1645.

  • Newton AD, Datta J, Loaiza-Bonilla A, Karakousis GC, Roses RE. Neoadjuvant therapy for gastric cancer: current evidence and future directions. J Gastrointest Oncol. 2015 Oct;6(5):534-43. doi: 10.3978/j.issn.2078-6891.2015.047.

    PubMed 26487948

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

Questions about this trial

What is this clinical trial studying?

A study testing Family-supervised Multimodal Prehabilitation in people with Stomach Neoplasms and Neoadjuvant Therapy, run by The Affiliated Hospital of Qingdao University 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 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: opening soon, as of the sponsor's last update on 19 Sep 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 Yanbing Zhou (+86532-82911847, zhouyanbing999@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative complications within 30 days after surgery (time frame: Within 30 days 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 NCT07183358, which also lists 6 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 19 Sep 2025.

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