Colon CancerGEPOCNCT03719573
Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer
A study testing Geriatric intervention in people with Colon Cancer and Colon Neoplasm, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
The GEPOC study investigates the effect of comprehensive geriatric assessment and intervention for frail older patients (65 years or older) undergoing elective surgery for colorectal cancer. the geriatric intervention will be pre- and postoperative. included in the intervention is an exercise intervention. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colon Cancer, Colon Neoplasm, Frail Elderly Syndrome
- What is being tested?
- Geriatric intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Feb 2019to 10 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elective surgery for colorectal cancer
- frail
- ability to read and speak danish (informed concent)
Who cannot join
- any physical condition that hinder physical exercise (eg. no legs)
- not able to concent
Trial locations and contacts
1 site in 1 country.
About this study
The GEPOC study investigates the effect of comprehensive geriatric assessment and intervention for frail older patients (65 years or older) undergoing elective surgery for colorectal cancer. the geriatric intervention will be pre- and postoperative. included in the intervention is an exercise intervention.
The main aim of the study us to see if the functional decline in this group can be reduced.
Read the detailed description
This is a randomized, controlled trial on frail older patients (aged 65 years or older) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized intervention. Patients in the intervention group will participate in planned exercise programs before surgery, perioperative and postoperative.
- Being tested
- Geriatric intervention
- Keywords
- Colon Cancer, Frailty, Geriatric assessment, perioperative care, exercise, quality of recovery, colorectal
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric interventionOther
A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric intervention | Experimental | A comprehensive geriatric assessment and intervention, including exercise program. Receives: Other: Geriatric intervention |
| control. | No intervention | Usual treatment and care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-second chair stand test (30s-CST)
functional test measuring lower body strength
Measured: baseline to 14 weeks after surgery
Secondary outcomes (22)
physical function and capacity - 6-minute-walk-test
6-minute-walk-test
Measured: baseline to 14 weeks after surgery
physical function and capacity - hand grip strength
hand grip strength
Measured: baseline to 14 weeks after surgery
physical function and capacity - 6-meter gait speed
6-meter gait speed
Measured: baseline to 14 weeks after surgery
Patient reported Quality of Life: EORTC
EORTC European Organisation for Research and Treatment of Cancer questionnaire C30 (30-126 points where 30 is the worst)
Measured: baseline to 14 weeks after surgery
Patient reported Quality of Life: EORTC ELD14
EORTC European Organisation for Research and Treatment of Cancer questionnaire conjoined with ELD14 (Elderly Cancer Patient module) (14-54 points where 54 is the worst)
Measured: baseline to 14 weeks after surgery
Quality of recovery after surgery: questionnaire
Measured with the questionnaire: Quality of Recovery - 15 questionnaire (0-150 points where 0 points is the worst)
Measured: 1 day before surgery (baseline) to 3 days after surgery
body composition
measured by Bioimpedance assessment
Measured: baseline to 14 weeks after surgery.
body composition
measured by dual-energy x-ray absorptiometry
Measured: baseline to 14 weeks after surgery.
inflammatory biomarker - CRP
the concentration of CRP (CRP C-reactive Protein)
Measured: baseline to 14 weeks after surgery
inflammatory biomarker - Interleukin 6
the concentration of interleukin 6
Measured: baseline to 14 weeks after surgery
inflammatory biomarker YKL-40
the concentration of YKL-40 (YKL-40 is also known as Chitinase-3-like protein 1)
Measured: baseline to 14 weeks after surgery
inflammatory biomarkers immuno-oncology
the concentration of 92 proteins associated with immuno-oncology (OLink)
Measured: baseline to 14 weeks after surgery
sarcopenia biomarker GDF-11
the concentration of GDF-11 (GDF Growth Differentiation Factor)
Measured: baseline to 14 weeks after surgery
sarcopenia biomarker GDF
the concentration of GDF-15 (GDF Growth Differentiation Factor)
Measured: baseline to 14 weeks after surgery
Postoperative complications
Measured with Clavien Dindo classification (grade I-V where grade V is death)
Measured: 30 days + 90 days
readmission
Number of patients being readmitted to hospital within 30 + 90 days after operation for colon surgery.
Measured: 30 days after surgery and 90 days after surgery
survival
number of survivors after surgery
Measured: 10 years
mortality
number of patients death
Measured: baseline to 3 months
number of patients to start up of adjuvant chemotherapy after surgery.
according to guidelines, if physical condition allows it (and patient accepts it).
Measured: 14 weeks
start up time of adjuvant chemotherapy after surgery
measured in days (if relevant)
Measured: 14 weeks
number of series of adjuvant chemotherapy
Measured: 14 weeks
doses of adjuvant chemotherapy
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start21 Feb 2019
- Primary completion10 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden, University of Copenhagen
- Responsible party
- Principal investigator, Troels Gammeltoft Dolin, Herlev and Gentofte Hospital
- Investigators
- Julia S Johansen, MD, PhD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719573
- Sponsor's protocol ID
- 123
- Acronym
- GEPOC
- Status last verified
- Aug 2022
- First submitted
- 19 Oct 2018
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: TBA
Publications
Dolin TG, Mikkelsen MK, Jakobsen HL, Vinther A, Zerahn B, Nielsen DL, Johansen JS, Lund CM, Suetta C. The prevalence of sarcopenia and cachexia in older patients with localized colorectal cancer. J Geriatr Oncol. 2023 Jan;14(1):101402. doi: 10.1016/j.jgo.2022.11.001. Epub 2022 Nov 21.
PubMed 36424269Dolin TG, Mikkelsen M, Jakobsen HL, Nordentoft T, Pedersen TS, Vinther A, Zerahn B, Vistisen KK, Suetta C, Nielsen D, Johansen JS, Lund CM. Geriatric assessment and intervention in older vulnerable patients undergoing surgery for colorectal cancer: a protocol for a randomised controlled trial (GEPOC trial). BMC Geriatr. 2021 Jan 30;21(1):88. doi: 10.1186/s12877-021-02045-9.
PubMed 33516195
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03719573
- Acronym / sponsor ID
- GEPOC / 123
- Keywords
- Colon Cancer, Frailty, Geriatric assessment, perioperative care, exercise, quality of recovery, colorectal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Velux Fonden, University of Copenhagen
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GEPOC study investigates the effect of comprehensive geriatric assessment and intervention for frail older patients (65 years or older) undergoing elective surgery for colorectal cancer. the geriatric intervention will be pre- and postoperative. included in the intervention is an exercise intervention.
The main aim of the study us to see if the functional decline in this group can be reduced.
Detailed description
This is a randomized, controlled trial on frail older patients (aged 65 years or older) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized intervention. Patients in the intervention group will participate in planned exercise programs before surgery, perioperative and postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geriatric intervention | Experimental | Other: Geriatric interventionA comprehensive geriatric assessment and intervention, including exercise program. |
| control. | No intervention | –Usual treatment and care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- elective surgery for colorectal cancer
- frail
- ability to read and speak danish (informed concent)
Key exclusion criteria (2 listed)
- any physical condition that hinder physical exercise (eg. no legs)
- not able to concent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric interventionA comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA. | Other | Geriatric intervention |
Primary outcome
30-second chair stand test (30s-CST)
Time frame: baseline to 14 weeks after surgery
functional test measuring lower body strength
22 secondary outcomes
physical function and capacity - 6-minute-walk-test
Time frame: baseline to 14 weeks after surgery
physical function and capacity - hand grip strength
Time frame: baseline to 14 weeks after surgery
physical function and capacity - 6-meter gait speed
Time frame: baseline to 14 weeks after surgery
Patient reported Quality of Life: EORTC
Time frame: baseline to 14 weeks after surgery
Patient reported Quality of Life: EORTC ELD14
Time frame: baseline to 14 weeks after surgery
Quality of recovery after surgery: questionnaire
Time frame: 1 day before surgery (baseline) to 3 days after surgery
body composition
Time frame: baseline to 14 weeks after surgery.
body composition
Time frame: baseline to 14 weeks after surgery.
inflammatory biomarker - CRP
Time frame: baseline to 14 weeks after surgery
inflammatory biomarker - Interleukin 6
Time frame: baseline to 14 weeks after surgery
inflammatory biomarker YKL-40
Time frame: baseline to 14 weeks after surgery
inflammatory biomarkers immuno-oncology
Time frame: baseline to 14 weeks after surgery
sarcopenia biomarker GDF-11
Time frame: baseline to 14 weeks after surgery
sarcopenia biomarker GDF
Time frame: baseline to 14 weeks after surgery
Postoperative complications
Time frame: 30 days + 90 days
readmission
Time frame: 30 days after surgery and 90 days after surgery
survival
Time frame: 10 years
mortality
Time frame: baseline to 3 months
number of patients to start up of adjuvant chemotherapy after surgery.
Time frame: 14 weeks
start up time of adjuvant chemotherapy after surgery
Time frame: 14 weeks
number of series of adjuvant chemotherapy
Time frame: 14 weeks
doses of adjuvant chemotherapy
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 36424269Dolin TG, Mikkelsen MK, Jakobsen HL, Vinther A, Zerahn B, Nielsen DL, Johansen JS, Lund CM, Suetta C. The prevalence of sarcopenia and cachexia in older patients with localized colorectal cancer. J Geriatr Oncol. 2023 Jan;14(1):101402. doi: 10.1016/j.jgo.2022.11.001. Epub 2022 Nov 21.
- Derived from this study: PubMed 33516195Dolin TG, Mikkelsen M, Jakobsen HL, Nordentoft T, Pedersen TS, Vinther A, Zerahn B, Vistisen KK, Suetta C, Nielsen D, Johansen JS, Lund CM. Geriatric assessment and intervention in older vulnerable patients undergoing surgery for colorectal cancer: a protocol for a randomised controlled trial (GEPOC trial). BMC Geriatr. 2021 Jan 30;21(1):88. doi: 10.1186/s12877-021-02045-9.
- Individual participant dataSharing planned: Undecided. TBA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia S Johansen, MD, PhD study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric intervention in people with Colon Cancer and Colon Neoplasm, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-second chair stand test (30s-CST) (time frame: baseline to 14 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03719573, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.