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

Gastric Cancer Clinical Trial

Official title:

Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy: a Multicenter, Open-label, Phase 3 Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03654534
• Other study ID #: SYSUCCGPS3
• Status: Recruiting
• Phase: Phase 3
• Start date: April 16, 2019
• Est. completion date: June 15, 2021

Study information

• Verified date: April 2019
• Source: Sun Yat-sen University
• Contact: Zhiwei Zhou, Ph.D.
• Phone: 86(020)87343626
• Email: zhouzhw[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 374
• Est. completion date: June 15, 2021
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. be proven to be primary adenocarcinoma of gastric cancer and pathological confirmed stage II-III or T1N1M0

2. age: 18-75 years

3. Eastern Cooperative Oncology Group performance status: 0~2

4. body mass index: 18.5-28.0kg/m2

5. able to ingest semiliquid diet

6. without other malignancies with exception of the cured cervical carcinoma in situ and basal cell carcinoma

7. anticipated overall survival time = 6 months

8. anticipated period of adjuvant chemotherapy = 3

9. without severe mental disorder

10. without severe digestive disease

11. without Acquired Immune Deficiency Syndrome or diabetes mellitus

12. without communication barrier

13. informed consensus of patients

Exclusion Criteria:

1. with unstable hemodynamics

2. with severe nausea or vomit which cannot be controlled by drugs

3. allergic reaction to NutrenOpimum

4. dysfunction of other organs

5. with severe disease, such as infection, stroke, heart failure or stock

6. other situation to be judged not adaptive to the study by investigators

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Dietary Supplement:
• NutrenOpimum
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.

Locations

Country	Name	City	State
China	SunYat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	chemotherapy withdrawal	chemotherapy withdrawal by the adverse events or recurrence	6 months
Secondary	time to adjuvant chemotherapy failure	Time to adjuvant treatment chemotherapy failure (TTF) were calculated using the Kaplan-Meier method and compared by the log-rank test	6 months
Secondary	period of adjuvant chemotherapy	period of adjuvant chemotherapy	6 months
Secondary	quality of life	quality of life at 1,3 and 6 months as evaluated by EORTC QLQ-C30	6 months
Secondary	grade 3/4 neutropenia, thrombocytopenia, anemia	grade 3/4 neutropenia, thrombocytopenia, anemia during adjuvant chemotherapy	6 months
Secondary	severe side effects on digestive tract	severe side effects on digestive tract during adjuvant chemotherapy	6 months