Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy

NCT03654534 | Unknown Phase 3

• 1 other identifier: SYSUCCGPS3
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

Background: It is known that postoperative malnutrition remains inevitable for gastric cancer patients with adjuvant chemotherapy, which could have prejudicial influence on the compliance of subsequent adjuvant chemotherapy and survival of the patients. A multi-institutional prospective phase 2 study had demonstrated the efficacy of oral nutritional supplements (ONS) for gastric cancer patients undergoing gastrectomy. However, previous studies did not focus the gastric cancer patients with adjuvant chemotherapy. Thus, it is unknown whether the ONS could benefit the gastric cancer patients with adjuvant chemotherapy. A multicenter, phase 3 randomised controlled trial was conducted to compare the ONS with standard diet for postoperative gastric cancer patients with adjuvant chemotherapy. Patients and method: In this study, pathological confirmed stage II-III or T1N1M0 gastric cancer patients who are supposed to receive adjuvant chemotherapy, aged from 18 to 75 years, with body mass index (BMI) from 18.5 to 28.0 kg/m2, and with Eastern Cooperative Oncology Group performance status ≤2, are randomized 1:1 to receive oral administration of NutrenOpimum (Nestle Suisse S.A.), a liquid enteral nutritional food for special medical purpose (FSMP), or standard diet. NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively. The primary end point was postoperative malnutrition, as defined as ratio of the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%; body weight loss ratio at 1, 3, 6 months. Secondary end points were chemotherapy withdrawal, time to adjuvant chemotherapy failure, period of adjuvant chemotherapy, quality of life, grade 3/4 neutropenia, thrombocytopenia, anemia, and severe side effects on digestive tract. Final study analysis will be conducted after the last patient's enrollment.

Conditions

Gastric Cancer

Keywords

gastric cancer; chemothrapy; oral nutritional supplements; malnutrition

Outcome Measures

Primary Outcomes (2)

• postoperative malnutrition

  the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%

  3 months postoperatively

• body weight loss ratio at 1, 3, 6 months

  the ratio of the weight loss at 1,3,6 months postoperatively to the days 7 postoperatively body weight

  1,3,6 months postoperatively

Secondary Outcomes (6)

• chemotherapy withdrawal

  6 months

• time to adjuvant chemotherapy failure

  6 months

• period of adjuvant chemotherapy

  6 months

• quality of life

  6 months

• grade 3/4 neutropenia, thrombocytopenia, anemia

  6 months

Study Arms (2)

oral nutritional supplements

EXPERIMENTAL

NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively.

Dietary Supplement: NutrenOpimum

standard diet

NO INTERVENTION

The control group was given no additional postoperative nutritional supplementation (standard diet).

Interventions

NutrenOpimum DIETARY_SUPPLEMENT

NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively.

oral nutritional supplements

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be proven to be primary adenocarcinoma of gastric cancer and pathological confirmed stage II-III or T1N1M0
• age: 18-75 years
• Eastern Cooperative Oncology Group performance status: 0\~2
• body mass index: 18.5-28.0kg/m2
• able to ingest semiliquid diet
• without other malignancies with exception of the cured cervical carcinoma in situ and basal cell carcinoma
• anticipated overall survival time ≥ 6 months
• anticipated period of adjuvant chemotherapy ≥ 3
• without severe mental disorder
• without severe digestive disease
• without Acquired Immune Deficiency Syndrome or diabetes mellitus
• without communication barrier
• informed consensus of patients

You may not qualify if:

• with unstable hemodynamics
• with severe nausea or vomit which cannot be controlled by drugs
• allergic reaction to NutrenOpimum
• dysfunction of other organs
• with severe disease, such as infection, stroke, heart failure or stock
• other situation to be judged not adaptive to the study by investigators

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SunYat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Zhiwei Zhou, Ph.D.

  SunYat-sen University

  STUDY CHAIR

Central Study Contacts

Zhiwei Zhou, Ph.D.

CONTACT

86(020)87343626; zhouzhw@sysucc.org.cn

Runcong Nie, Ph.D.

CONTACT

86-15626447119; nierc@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: August 31, 2018
• Study Start: April 16, 2019
• Primary Completion: September 16, 2020
• Study Completion: June 15, 2021
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)