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

City of Hope

Status: Active, not recruiting

Conditions: Pathologic Stage IIB Gastric Cancer AJCC v8; Clinical Stage I Gastric Cancer AJCC v8; Clinical Stage IIB Gastric Cancer AJCC v8; Clinical Stage 0 Gastric Cancer AJCC v8; Clinical Stage IIA Gastric Cancer AJCC v8; Pathologic Stage III Gastric Cancer AJCC v8; Gastric Adenocarcinoma; Pathologic Stage I Gastric Cancer AJCC v8; Pathologic Stage IIIB Gastric Cancer AJCC v8; Pathologic Stage IIIA Gastric Cancer AJCC v8; Clinical Stage II Gastric Cancer AJCC v8; Pathologic Stage 0 Gastric Cancer AJCC v8; Pathologic Stage IIA Gastric Cancer AJCC v8; Pathologic Stage IB Gastric Cancer AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Pathologic Stage IIIC Gastric Cancer AJCC v8; Pathologic Stage IA Gastric Cancer AJCC v8; Pathologic Stage II Gastric Cancer AJCC v8

Treatments: Other: Best Practice; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03997162

NCI-2018-01639 (Registry Identifier)

17482

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

52 participants in 1 patient group

Observational (ERAS protocol)

Description:

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

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Best Practice