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

NCT ID: NCT03997162

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-11

Study Completion Date

2026-02-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (ERAS protocol)

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

Best Practice

Intervention Type OTHER

Complete standard of care enhanced recovery after surgery protocol

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Complete standard of care enhanced recovery after surgery protocol

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Quality of Life Assessment

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yanghee Woo

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2018-01639

Identifier Type: REGISTRY

Identifier Source: secondary_id

17482

Identifier Type: OTHER

Identifier Source: secondary_id

17482

Identifier Type: -

Identifier Source: org_study_id

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