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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997162
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief 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.

Condition or disease Intervention/treatment
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 Other: Best Practice Other: Quality-of-Life Assessment Other: Questionnaire Administration

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Gastric Cancer Enhanced Recovery After Surgery Pathway
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Group/Cohort Intervention/treatment
Observational (ERAS protocol)
Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.
Other: Best Practice
Complete standard of care enhanced recovery after surgery protocol
Other Names:
  • standard of care
  • standard therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Length of stay [ Time Frame: from date of surgery to discharge from hospital, assessed up to 30 days ]
    Will determine the length of hospital stay after surgery

  2. Rate and type of post-operative complications [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. Overall quality of life assessment [ Time Frame: 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 ]
    EORTC QLQ-C30 questionnaires to measure Quality of life

  2. QoL after stomach cancer surgery [ Time Frame: 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 ]
    STO22 questionnaires to measure stomach cancer surgery related QoL


Other Outcome Measures:
  1. Ambulation [ Time Frame: From time of surgery to first postoperative clinic visit, assessed up to 30 days ]
    Number of steps taken after surgery as measured by a podometer

  2. Immune biomarkers [ Time Frame: 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 ]
    Blood levels of hsCRP will be measured before and after surgery to determine its relationship to complications and recurrence

  3. Disease free survival of enrolled patients [ Time Frame: Up to 14 months after surgery ]
  4. Overall survival of enrolled patients [ Time Frame: Up to 14 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a biopsy proven diagnosis of gastric adenocarcinoma who are undergoing curative gastric surgery or prophylactic total gastrectomy for genetic risk
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997162


Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Yanghee Woo    626-218-7100    ywoo@coh.org   
Principal Investigator: Yanghee Woo         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Yanghee Woo City of Hope Medical Center
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT03997162    
Other Study ID Numbers: 17482
NCI-2018-01639 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
17482 ( Other Identifier: City of Hope Comprehensive Cancer Center )
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases