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NCT Number: NCT06521541

Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy

The intention of research is to establish a multimodal prehabilitation protocol in patients who undergo neoadjuvant chemotherapy prior to gastrectomy, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, fitness and long-term prognosis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, 266000, China

Location status: Recruiting

Location contact

Yanbing Zhou, MD

CONTACT

[email protected]

86532-82911324

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
  • Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
  • The feasibility of neoadjuvant therapy was suggested by MDT, and the feasibility of radical gastrectomy was re-evaluated after neoadjuvant therapy;
  • Blood routine, liver function, kidney function, heart function and lung function were normal before neoadjuvant therapy, and there was no contraindication of chemotherapy and surgery;
  • The pregnancy test was negative within 1 month, and she was not pregnant or breastfeeding;
  • Informed consent and ability to comply with research protocols.

Exclusion criteria

  • metastasis;
  • End-stage cardiac insufficiency (LVEF<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV;
  • Cerebral hemorrhage, cerebral infarction, TIA or central nervous system disease or mental illness within 6 months, could not cooperate with the completion of neoadjuvant therapy and pre-rehabilitation exercise;
  • Patients have severe infections (such as MODS, etc.) or have allergic reactions to chemotherapy drugs and metabolic disorders;
  • Concurrent tumors or other diseases requiring simultaneous surgery (except laparoscopic gallbladder surgery);
  • Emergency surgery is required due to tumor complications (e.g., bleeding, perforation, obstruction);
  • Patients participating in other clinical trials.

Treatment and study plan

Multimodal prehabilitation Program

Behavioral

Patients adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.Patients were evaluated for changes during neoadjuvant therapy and postoperative recovery

ERAS program

Behavioral

The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.

Primary outcomes

  1. Cardiopulmonary capacity

    Time frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)

    The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardiopulmonary function.

Secondary outcomes

  1. Patient's quality of life

    Time frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)

    QoL comprises patient-reported outcomes (PRO) of physical symptoms and psychosocial health status. Quality of Life Questionnaire (QLQ) C30 is sensitive tool for measuring individual performance status. Each index score ranges from 1 to 4, with higher scores indicating higher risk.

  2. Serum albumin levels

    Time frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)

    The level of Serum albumin is used to assess nurtritional status.

  3. sarcopenia

    Time frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)

    At the L3 level, total SM will be measured. Skeletal muscle index (SMI) will be calculated as follows: SM/height(m)2. SMI is used to assess nurtritional status.

  4. completetion of neoadjuvant chemotherapy

    Time frame: Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks)

    Discontinued due to adverse reactions

  5. First exhaust and defecation

    Time frame: Postoperative (≤30 days after surgery)

    First exhaust and defecation is used to assess the postoperative recovery course.

  6. First liquid diet

    Time frame: Postoperative (≤30 days after surgery)

    First liquid diet is used to assess the postoperative recovery course.

  7. The incidence of postoperative complications

    Time frame: Postoperative (≤30 days after surgery)

    Refers to the incidence of early postoperative complications.

  8. Duration of postoperative hospital stay

    Time frame: Postoperative (≤30 days after surgery)

    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

  9. Hospitalization costs

    Time frame: Postoperative (≤30 days after surgery)

    The expense from admission to discharge

  10. 3-year recurrence-free survival

    Time frame: 3 years

    3-year recurrence-free survival (RFS) rate

  11. 3-year overall survival

    Time frame: 3 years

    3-year overall survival (OS) rate

Study contacts

Contact information is provided by the study sponsor or research team.

Qi Liu

CONTACT

[email protected]

86532-82911324

Yanbing Zhou, MD

CONTACT

[email protected]

86532-82911324

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy : A Single Center Randomized Control Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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