Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery

Gastric Adenocarcinoma Clinical Trial

Official title:

Gastric Cancer Enhanced Recovery After Surgery Pathway

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03997162
• Other study ID #: 17482
• Secondary ID: NCI-2018-0163917
• Status: Active, not recruiting
• Start date: October 11, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This phase II trial studies how well an early recovery after surgery protocol works in enhancing quality of life in participants with stage 0-IIIC gastric cancer undergoing surgery. The early recovery after surgery protocol may decrease pain and nausea, promote bowl function, decrease the number of days hospitalized, and improve a participant's ability to function normally after surgery.

Description:

PRIMARY OBJECTIVES:

I. Determine how the enhanced recovery after surgery (ERAS) protocol affects patient?s length of hospital stay after radical gastrectomy.

II. Determine the association between ambulation (number of steps taken) while hospitalized and complications.

III. Determine the association between pre-operatively and postoperatively drawn biochemical markers and complications, disease free survival, and overall survival.

OUTLINE:

Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.

After completion of study, participants are followed up at days 14, 30, 80-110, and 170-200, and at 11-14 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: December 31, 2024
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients to be included are those with a biopsy proven diagnosis of gastric adenocarcinoma who are undergoing curative gastric surgery or prophylactic total gastrectomy for genetic risk.

• Patients with clinical stage 0-IIIC will be included.

• Any performance status and any life expectancy.

• The effects of gastric surgery on the developing fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.

• All subjects must have the ability to understand and the willingness to sign a written informed consent.

• Prior therapy will not be used as a limitation in this study.

Exclusion Criteria:

• Patients will be excluded if they are not candidates for surgery

• Patients will be excluded from the study if they have had prior gastric surgery, with the exception of a gastrostomy tube.

• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Clinical Stage 0 Gastric Cancer AJCC v8
• Clinical Stage I Gastric Cancer AJCC v8
• Clinical Stage II Gastric Cancer AJCC v8
• Clinical Stage IIA Gastric Cancer AJCC v8
• Clinical Stage IIB Gastric Cancer AJCC v8
• Clinical Stage III Gastric Cancer AJCC v8
• Gastric Adenocarcinoma
• Pathologic Stage 0 Gastric Cancer AJCC v8
• Pathologic Stage I Gastric Cancer AJCC v8
• Pathologic Stage IA Gastric Cancer AJCC v8
• Pathologic Stage IB Gastric Cancer AJCC v8
• Pathologic Stage II Gastric Cancer AJCC v8
• Pathologic Stage IIA Gastric Cancer AJCC v8
• Pathologic Stage IIB Gastric Cancer AJCC v8
• Pathologic Stage III Gastric Cancer AJCC v8
• Pathologic Stage IIIA Gastric Cancer AJCC v8
• Pathologic Stage IIIB Gastric Cancer AJCC v8
• Pathologic Stage IIIC Gastric Cancer AJCC v8
• Stomach Neoplasms

Intervention

Other:
• Best Practice
Complete standard of care enhanced recovery after surgery protocol
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ambulation	Number of steps taken after surgery as measured by a podometer	From time of surgery to first postoperative clinic visit, assessed up to 30 days
Other	Immune biomarkers	Blood levels of hsCRP will be measured before and after surgery to determine its relationship to complications and recurrence	one time 30 days within surgery, One time 1 day after surgery, One time 3 days after surgery, One time 30 days after surgery, One time 90 days after surgery, one time 6 months after surgery, One time 12 months after surgery
Other	Disease free survival of enrolled patients		Up to 14 months after surgery
Other	Overall survival of enrolled patients		Up to 14 months after surgery
Primary	Length of stay	Will determine the length of hospital stay after surgery	from date of surgery to discharge from hospital, assessed up to 30 days
Primary	Rate and type of post-operative complications		Up to 1 year
Secondary	Overall quality of life assessment	EORTC QLQ-C30 questionnaires to measure Quality of life	One time within 30 days of surgery, One time within 30 days after surgery, One time at 3 months after surgery, One time 6 months after surgery, One time 12 months after surgery
Secondary	QoL after stomach cancer surgery	STO22 questionnaires to measure stomach cancer surgery related QoL	One time within 30 days of surgery, One time within 30 days after surgery, One time at 3 months after surgery, One time 6 months after surgery, One time 12 months after surgery