Gastric CancerNCT06055387
Frailty Assessment and Intervention in Elderly Patients with Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy
A study testing Frailty intervention measures in people with Gastric Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Gastric cancer ranks among the top ten leading causes of death in Taiwan. Radical surgery is the sole curative method for gastric cancer. However, our previous research has revealed that elderly gastric cancer patients undergoing radical surgery face a significantly elevated risk of postoperative complications. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Frailty intervention measures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged sixty-five or older with locally advanced (stage II and stage III) gastric cancer, preparing for curative gastric cancer surgery and scheduled to receive adjuvant chemotherapy within 4-8 weeks postoperatively, either as outpatients or inpatients.
- Patients must provide signed informed consent.
- Estimated survival of more than 3 months.
- Conscious and able to communicate verbally or in writing, and willing to cooperate with invasive procedures.
Who cannot join
- Patients with cognitive impairment or unable to cooperate with the interventional procedures as determined by the clinical physician.
- Patients receiving concurrent other anticancer treatments (radiation or surgery).
- Patients with multiple types of cancer requiring simultaneous treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 330
Wen-Chi Chou, +8863281200 ext. 8426, f12986@cgmh.org.tw
About this study
Gastric cancer ranks among the top ten leading causes of death in Taiwan. Radical surgery is the sole curative method for gastric cancer. However, our previous research has revealed that elderly gastric cancer patients undergoing radical surgery face a significantly elevated risk of postoperative complications. Even after gastric cancer resection, only 70% of patients receive adjuvant chemotherapy, with a particularly low likelihood among those aged ≥ 65 to undergo such treatment. With the increasing elderly population in our country, an increasing number of elderly gastric cancer patients must decide whether they can withstand radical surgery for gastric cancer and whether to undergo adjuvant chemotherapy. Therefore, increasing the rates of elderly gastric cancer patients undergoing radical surgery and adjuvant chemotherapy, as well as improving the success rate of chemotherapy, has become a critical issue.
Frailty has been a frequent topic in geriatric medicine in recent years. It involves assessing multifaceted aspects of physical functioning to determine an individual's frailty status, which can help predict the likelihood of severe side effects from medical interventions. International organizations like the American Cancer Society recommend frailty assessment for all elderly cancer patients before undergoing chemotherapy and corresponding interventions to address frailty. However, there is a lack of large-scale studies on frailty assessment and its practical clinical benefits in our population.
Read more
This study is a prospective, open-label, randomized clinical trial designed to investigate the impact of geriatric intervention on the tolerance of surgery/chemotherapy in patients diagnosed with gastric cancer. As part of the study protocol, all enrolled patients will undergo a comprehensive frailty assessment within a window of 7 days before initiating their first treatment, followed by tailored geriatric interventions.
The primary objective of this study is to assess and compare the effects of geriatric intervention on postoperative complications, chemotherapy tolerance, treatment-related toxicity, and overall quality of life among two distinct groups: frail and non-frail patients. Our research team aims to promote widespread frailty assessment and interventions with the following objectives:
- Reduce the probability of postoperative complications among elderly gastric cancer patients receiving surgery.
- Enhance the tolerance and success rate of adjuvant chemotherapy for gastric cancer.
These efforts ultimately aim to improve the survival prognosis of this patient group.
- Conditions
- Gastric Cancer
- Being tested
- Frailty intervention measures
- Keywords
- Frailty, Comprehensive Geriatric Assessment (CGA), Outcome, Radical surgery, Adjuvant chemotherapy
- Medical subject headings
- Stomach Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty intervention measuresBehavioural
Providing specialized guidance:
- Physical Function and Fall History:
- Prioritizing home safety for those with physical impairments.
- Arranging rehab consultations when necessary.
- Nutrition:
- Assessing diets and offering education.
- Pre-treatment nutritionist assessments.
- Monitoring weight, intervening if >5-10% loss, or >10% loss.
- Social Support:
- Evaluating the needs of those without family support.
- Referring to social services and introducing care resources.
- Cognition:
- Detecting cognitive issues, addressing reversible causes.
- Assessing decision-making and medication self-administration.
- Refer to specialists when needed.
- Polypharmacy and Comorbidity:
- Collecting medication data, ensuring adherence.
- Noting chronic illnesses.
- Collaborating with specialists or pharmacists for complex cases.
- Psychological:
- Providing weekly support for psychological concerns.
- Refer to specialists for assessments and treatment options.
| Study group | Role | What they receive |
|---|---|---|
| Frail group | Experimental | All patients receive a frailty assessment within 7 days before initiating treatment, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The frail group will receive management and recommendations based on the specific impairment domain. Receives: Behavioral: Frailty intervention measures |
| Non-frail group | No intervention | All patients receive a frailty assessment within 7 days before initiating treatment, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The non-frail group will not receive additional interventions, but the clinical physicians will still provide appropriate treatment based on the patient's condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing surgical complications between frail and non-frail patients using the Clavien-Dindo grading system.
Measured: After completion 3 months treatment.
Utilize CTCAE v5.0 to assess the grade and frequency of adverse events and treatment-related toxicity in frail and non-frail patient groups, and compare the differences between the two.
Measured: After completion 3 months treatment.
Secondary outcomes (2)
Examine whether implementing appropriate frailty interventions can reduce the likelihood of adverse events, as assessed by the Clavien-Dindo grading system or CTCAE v5.0, occurring in frail groups three months after initiating treatment.
The frail group will receive management and recommendations based on the specific impairment domain.
Measured: After completion 6 months treatment.
To compare overall survival between two distinct groups: frail and non-frail patients.
Measured: up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055387
- Sponsor's protocol ID
- 202101510B0C601
- Status last verified
- Feb 2025
- First submitted
- 29 Aug 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Assessment and Intervention in Elderly Patients with Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06055387
- Acronym / sponsor ID
- 202101510B0C601
- Conditions
- Gastric Cancer
- Keywords
- Frailty, Comprehensive Geriatric Assessment (CGA), Outcome, Radical surgery, Adjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Sep 2023 (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.
Gastric cancer ranks among the top ten leading causes of death in Taiwan. Radical surgery is the sole curative method for gastric cancer. However, our previous research has revealed that elderly gastric cancer patients undergoing radical surgery face a significantly elevated risk of postoperative complications. Even after gastric cancer resection, only 70% of patients receive adjuvant chemotherapy, with a particularly low likelihood among those aged ≥ 65 to undergo such treatment. With the increasing elderly population in our country, an increasing number of elderly gastric cancer patients must decide whether they can withstand radical surgery for gastric cancer and whether to undergo adjuvant chemotherapy. Therefore, increasing the rates of elderly gastric cancer patients undergoing radical surgery and adjuvant chemotherapy, as well as improving the success rate of chemotherapy, has become a critical issue.
Frailty has been a frequent topic in geriatric medicine in recent years. It involves assessing multifaceted aspects of physical functioning to determine an individual's frailty status, which can help predict the likelihood of severe side effects from medical interventions. International organizations like the American Cancer Society recommend frailty assessment for all elderly cancer patients before undergoing chemotherapy and corresponding interventions to address frailty. However, there is a lack of large-scale studies on frailty assessment and its practical clinical benefits in our population.
This study is a prospective, open-label, randomized clinical trial designed to investigate the impact of geriatric intervention on the tolerance of surgery/chemotherapy in patients diagnosed with gastric cancer. As part of the study protocol, all enrolled patients will undergo a comprehensive frailty assessment within a window of 7 days before initiating their first treatment, followed by tailored geriatric interventions.
The primary objective of this study is to assess and compare the effects of geriatric intervention on postoperative complications, chemotherapy tolerance, treatment-related toxicity, and overall quality of life among two distinct groups: frail and non-frail patients. Our research team aims to promote widespread frailty assessment and interventions with the following objectives:
- Reduce the probability of postoperative complications among elderly gastric cancer patients receiving surgery.
- Enhance the tolerance and success rate of adjuvant chemotherapy for gastric cancer.
These efforts ultimately aim to improve the survival prognosis of this patient group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail group | Experimental | Behavioral: Frailty intervention measuresAll patients receive a frailty assessment within 7 days before initiating treatment, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The frail group will receive management and recommendations based on the specific impairment domain. |
| Non-frail group | No intervention | –All patients receive a frailty assessment within 7 days before initiating treatment, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The non-frail group will not receive additional interventions, but the clinical physicians will still provide appropriate treatment based on the patient's condition. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients aged sixty-five or older with locally advanced (stage II and stage III) gastric cancer, preparing for curative gastric cancer surgery and scheduled to receive adjuvant chemotherapy within 4-8 weeks postoperatively, either as outpatients or inpatients.
- Patients must provide signed informed consent.
- Estimated survival of more than 3 months.
- Conscious and able to communicate verbally or in writing, and willing to cooperate with invasive procedures.
Key exclusion criteria (3 listed)
- Patients with cognitive impairment or unable to cooperate with the interventional procedures as determined by the clinical physician.
- Patients receiving concurrent other anticancer treatments (radiation or surgery).
- Patients with multiple types of cancer requiring simultaneous treatment.
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 |
|---|---|---|
| Frailty intervention measuresProviding specialized guidance: * Physical Function and Fall History: * Prioritizing home safety for those with physical impairments. * Arranging rehab consultations when necessary. * Nutrition: * Assessing diets and offering education. * Pre-treatment nutritionist assessments. * Monitoring weight, intervening if >5-10% loss, or >10% loss. * Social Support: * Evaluating the needs of those without family support. * Referring to social services and introducing care resources. * Cognition: * Detecting cognitive issues, addressing reversible causes. * Assessing decision-making and medication self-administration. * Refer to specialists when needed. * Polypharmacy and Comorbidity: * Collecting medication data, ensuring adherence. * Noting chronic illnesses. * Collaborating with specialists or pharmacists for complex cases. * Psychological: * Providing weekly support for psychological concerns. * Refer to specialists for assessments and treatment options. | Behavioural | Frail group |
Primary outcome
Comparing surgical complications between frail and non-frail patients using the Clavien-Dindo grading system.
Time frame: After completion 3 months treatment.
Utilize CTCAE v5.0 to assess the grade and frequency of adverse events and treatment-related toxicity in frail and non-frail patient groups, and compare the differences between the two.
Time frame: After completion 3 months treatment.
2 secondary outcomes
Examine whether implementing appropriate frailty interventions can reduce the likelihood of adverse events, as assessed by the Clavien-Dindo grading system or CTCAE v5.0, occurring in frail groups three months after initiating treatment.
Time frame: After completion 6 months treatment.
To compare overall survival between two distinct groups: frail and non-frail patients.
Time frame: up to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frailty intervention measures in people with Gastric Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing surgical complications between frail and non-frail patients using the Clavien-Dindo grading system. (time frame: After completion 3 months treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2025.