## Protocol Section
### Identification Module
**NCT ID:** NCT06419140

**Brief Title:** Multimodal Rehabilitation on Gastric Adenocarcinoma Patients Following Radical D2 Gastrectomy

**Official Title:** The Impact of Multimodal Rehabilitation on the Outcomes of Gastric Adenocarcinoma Patients Following Radical D2 Gastrectomy: A Phase II, Multicenter, Open Label, and Randomized Clinical Study

#### Organization Study ID Info
**ID:** IRB-2024-349
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhejiang Cancer Hospital

#### Responsible Party

**Investigator Affiliation:** Zhejiang Cancer Hospital

**Investigator Full Name:** Ying Jieer

**Investigator Title:** Chief physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study has established a multidisciplinary rehabilitation team to recruit patients who underwent radical D2 gastrectomy in multiple centers and divided them into a rehabilitation group and a control group. Intervention will be carried out every time the patients come to the hospital for adjuvant chemotherapy and review. The control group uses traditional intervention model, and the rehabilitation group uses combined exercise/nutrition/psychology rehabilitation intervention.

This study is expected to promote early recovery after gastric cancer surgery through multidisciplinary rehabilitation intervention, reduce the occurrence of complications, improve patients' tolerance to adjuvant chemotherapy, and improve patients' quality of life, and hope to improve the short-term and long-term outcomes of gastric cancer patients.

### Conditions Module

**Conditions:**

- Gastric Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 138

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation care

**Intervention Names:**

- Drug: Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation

**Label:** The rehabilitation group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard SOX/XELOX adjuvant chemotherapy without multimodal rehabilitation care

**Label:** The control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- The rehabilitation group

**Description:** Motivational counseling to perform nutritional, psychological, and exercise inventions

**Name:** Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Completion rate of 8 cycles of adjuvant chemotherapy

**Measure:** Adjuvant chemotherapy completion rate

**Time Frame:** At the end of Cycle 8 (each cycle is 21 days)

#### Secondary Outcomes

**Description:** Proportion of subjects who have been free of disease recurrence within 3 years from randomization.

**Measure:** 3-year disease-free survival (DFS)

**Time Frame:** 3 year

**Description:** Time from randomization to death

**Measure:** Overall survival

**Time Frame:** 3 year

**Description:** Measured by GAD-7 questionnaire

**Measure:** Emotional state

**Time Frame:** 2 year

**Description:** Weight

**Measure:** Weight

**Time Frame:** through study completion, an average of 2 year

**Description:** Adverse event were evaluated through CTCAE

**Measure:** Adverse event

**Time Frame:** At the end of Cycle 8 (each cycle is 21 days)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease
* Must be able to swallow tablets
* Age 18 to 75 years old
* Patients with gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) confirmed by histopathology to be in pathological stage II/III (based on the eighth edition of the AJCC Cancer Staging Manual)
* The patient underwent D2 radical resection within 3-6 weeks before randomization; and met the R0 resection criteria
* The patient can undergo postoperative adjuvant chemotherapy after being selected into the randomization group, and the regimen is SOX/XELOX
* Have not received previous anti-tumor treatment (including systemic chemotherapy and local radiotherapy), except for initial gastrectomy of the primary lesion
* ECOG status score 0 or 1, with physical conditions to participate in sports training、Have sufficient bone marrow reserve function, ANC ≥1.5×109/L, platelet count ≥75×109/L, Hb ≥90 g/L before enrollment, and no bleeding tendency
* Liver function test: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) are all ≤ 2.5×ULN; serum bilirubin ≤ 1.5×ULN. For patients known to have Gilbert's disease: Serum bilirubin level ≤ 3ｘULN
* Renal function test: Serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance \> 50 ml/min (calculated according to Cockroft-Gault)
* No mental illness, speech disorder or consciousness disorder, have certain understanding, communication and reading abilities, and be able to complete the questionnaire independently or with the assistance of the researcher
* During the study, at least one source of social support (family member or friend) can monitor the safety and compliance of the intervention program
* Can understand the situation of this study, and the patient and/or legal representative voluntarily agree to participate in this trial and sign the informed consent form.

Exclusion Criteria:

* Receive neoadjuvant chemotherapy or radiotherapy before surgery;
* Participate in other clinical trials related to health behavior within 3 months before the trial;
* Treated with any other study drugs or participated in another clinical trial with therapeutic intent within 28 days before enrollment;
* Uncontrolled serious medical illness that the investigator believes will affect the subject's acceptance of the rehabilitation program, such as combined serious medical illness, including severe heart disease (such as New York Heart Association (NYHA) Class II or worse congestion heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, etc.;
* Lack of ability to participate in sports training (such as: disability, paralysis of lower limbs, etc.); not suitable for participating in sports training, such as those suffering from skeletal muscle diseases, fractures within 6 months; suffering from exercise contraindications (angina pectoris, within 6 months) Myocardial infarction, congestive heart failure, chronic obstructive pulmonary disease, planned hip or knee replacement, use of a walker or wheelchair, recent stroke with hemiplegia, etc.);
* Those who are receiving other forms of nutritional intervention; those who refuse to use oral nutritional preparations;
* There is uncontrolled mental illness;
* Known active HIV, HBV and HCV infection;
* Patients with malignant tumors other than gastric cancer (except current gastric cancer) within the past 5 years; are eligible if they meet all the following criteria: treatment of malignant tumors with the purpose of cure, such as fully treated cervical cancer in situ, non-melanoma skin Cancer, localized prostate cancer after radical resection (PSA ≤ 10ng/ml); at the same time, no signs of recurrence or metastasis were found based on imaging follow-up results and any disease-specific tumor markers;
* Those with difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, or perforation;
* Pregnant or lactating female patients, or subjects of childbearing age who refuse to take contraceptive measures;
* Patients judged by the researcher to be unfit to participate in this study.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jieerying@aliyun.com

**Name:** Jieer Jieer, Dr

**Phone:** 0571-88122062

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hangzhou

**Country:** China

**Facility:** Zhejiang Cancer Hospital

**State:** Zhejiang

**Zip:** 310022

#### Overall Officials

**Official 1:**

**Affiliation:** Zhejiang Cancer Hospital

**Name:** Jieer Jieer, Dr

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: HIGH

- As Found: Adenocarcinoma

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000230

- Term: Adenocarcinoma

### Misc Info Module

- Version Holder: 2024-05-31
