Gastroesophageal Cancer (GC)CASENCT06687291
Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer
An observational study of Gastroesophageal Cancer (GC) and Postoperative Delirium (POD), run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Cancer (GC), Postoperative Delirium (POD), Quality of Life (QOL)
- How many people
- 130 participants
- Where
- 1 siteSweden
- Study dates
- 13 Feb 2025to 11 Nov 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with esophageal or gastric cancer who will be treated with (or without) chemotherapy and surgery at Karolinska University Hospital in Huddinge (Sweden).
Who may be able to join
- Patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery.
- Age ≥18 at the time for inclusion.
- Participate on a voluntary basis and can (for any reason) end its participation during the study.
- Capable of giving informed consent.
Who cannot join
- Patients with preoperative cognitive dysfunction such as dementia.
- Patients who are inoperable due to metastases.
- Patients unable to communicate due to severely impaired hearing and/or - seeing.
- Patients with ongoing drug and/or alcohol abuse.
- Patients who cannot give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital, Huddinge
Huddinge, 14157
Marcus Nömm PhD-student, 0733765652, marcus.nomm@ki.se
Maria Lampi PhD, 0852483721, maria.lampi@ki.se
About this study
The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia.
Participants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium.
The main objective aims to answer:
What is the incidence of POD after gastroesophageal cancer surgery.
- Conditions
- Gastroesophageal Cancer (GC), Postoperative Delirium (POD), Quality of Life (QOL), Frailty, Malnutrition, Sarcopenia
- Keywords
- postoperative delirium, gastroesophageal cancer, Frailty, Quality of life, Preoperative depression, Malnutrition, Sarcopenia, Chemobrain, Chemotherapy
- Medical subject headings
- Emergence Delirium, Frailty, Malnutrition, Sarcopenia, Chemotherapy-Related Cognitive Impairment, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants identified with postoperative delirium | Participants identified with postoperative delirium will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview in order to understand the participant's experience of postoperative delirium. | |
| CASE-study participants | All included participants in the CASE-study. * The assessment of cognitive function will be performed using the validated 4AT Test (4AT). Cognitive impact will be assessed at baseline before neoadjuvant chemotherapy (if chemotherapy is indicated) and at patient admission for surgery, postoperative day 1, 3 and 7, and at follow-up 4-8 weeks after surgery. * Risk factors for POD will be explored by investigate the relationship between postoperative delirium, chemotherapy preoperative depression, frailty, quality of life, malnutrition and sarcopenia. Patients will report health-related quality of life using the validated EORTC QLQC-C30 and EORTC QLQ-OG25 questionnaires. Frailty and depression will be measured preoperatively with Clinical Frailty Scale (CFS-9) and the Patient Health Questionnaire (PHQ-9). Malnutrition is evaluated by using Patient-Generated Subjective Global Assessment (PG-SGA). Sarcopenia is assessed through CT-scan, which is conducted as part of clinical routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
The assessment of cognitive function will be performed using the validated 4AT Test (4AT).
Cognitive impact will be assessed at baseline before neoadjuvant chemotherapy (if chemotherapy is indicated) and at patient admission for surgery, postoperative day 1, 3 and 7, and at follow-up 4-8 weeks after surgery.
Measured: From enrollment to the follow up meeting after surgery, approximate 6 months.
Secondary outcomes (5)
Preoperative depression
A risk factor for postoperative delirium is preoperative depression. Depression will be measured preoperatively with the Patient Health Questionnaire (PHQ-9).
Measured: From enrollment to admission for surgery
Preoperative frailty
Frailty is a risk factor for post operative delirium. Frailty will be measured preoperatively with Clinical Frailty Scale (CFS-9).
Measured: At admission for surgery
Health-related quality of life
Low score in quality of life is a risk factor for delirium. Patients will report health-related quality of life using the validated European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQC-C30) and EORTC validated Quality of Life Questionnaire for Oesophago-Gastric cancer (QLQ-OG25).
Measured: From enrollment to the follow up meeting after surgery, approximate 6 months.
Malnutrition
Patients with malnutrition before surgery have a higher risk of developing post-operative delirium. Malnutrition is assessed by using Patient-Generated Subjective Global Assessment (PG-SGA) before surgery.
Measured: At admission for surgery
Sarcopenia
There is association between preoperative sarcopenia and postoperative delirium in patients undergoing gastrointestinal cancer surgery. Sarcopenia is assessed by using CT-scan in clinical routine.
Measured: From enrollment to admission for surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start13 Feb 2025
- Primary completion11 Nov 2027 (estimated)
- Study completion11 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Cancer (GC)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Maria Lampi, Karolinska Institutet
- Investigators
- Maria Lampi, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687291
- Sponsor's protocol ID
- Ethical approval 2024-00971-01
- Acronym
- CASE
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tieges Z, Maclullich AMJ, Anand A, Brookes C, Cassarino M, O'connor M, Ryan D, Saller T, Arora RC, Chang Y, Agarwal K, Taffet G, Quinn T, Shenkin SD, Galvin R. Diagnostic accuracy of the 4AT for delirium detection in older adults: systematic review and meta-analysis. Age Ageing. 2021 May 5;50(3):733-743. doi: 10.1093/ageing/afaa224.
PubMed 33951145Liu J, Li J, Wang J, Zhang M, Han S, Du Y. Associated factors for postoperative delirium following major abdominal surgery: A systematic review and meta-analysis. Int J Geriatr Psychiatry. 2023 Jun;38(6):e5942. doi: 10.1002/gps.5942.
PubMed 37260053Loh KP, Janelsins MC, Mohile SG, Holmes HM, Hsu T, Inouye SK, Karuturi MS, Kimmick GG, Lichtman SM, Magnuson A, Whitehead MI, Wong ML, Ahles TA. Chemotherapy-related cognitive impairment in older patients with cancer. J Geriatr Oncol. 2016 Jul;7(4):270-80. doi: 10.1016/j.jgo.2016.04.008. Epub 2016 Jul 5.
PubMed 27197918Hughes CG, Boncyk CS, Culley DJ, Fleisher LA, Leung JM, McDonagh DL, Gan TJ, McEvoy MD, Miller TE; Perioperative Quality Initiative (POQI) 6 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Delirium Prevention. Anesth Analg. 2020 Jun;130(6):1572-1590. doi: 10.1213/ANE.0000000000004641.
PubMed 32022748