AgingNCT03640117
The Value of Geriatric Assessments in Older Patients With Breast Cancer
An observational study of Aging and Breast Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
Elderly cancer patients are a special group, often complicated by a variety of chronic diseases, which bring serious obstacles to surgery and adjuvant treatment. It is for these reasons that most patients with high-level evidence-based randomized controlled clinical trials will be part of these patients. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Aging, Breast Cancer, Chemotherapeutic Toxicity
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 May 2025
- Phase
- Observational
- 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: In this prospective cohort study, patients aged 70 years and older with breast cancer, completed geriatric assessment questionnaire prior to therapy. For patients accepted chemotherapy, toxicity after chemotherapy were recorded using WHO criteria.
Who may be able to join
- Confirmed by pathology for breast cancer
- Patients aged 70 years and older
Who cannot join
- Patients with severe mental decline who cannot cooperate with the questionnaire
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking university people's hospital
Beijing, Beijing Municipality, 100044
yuan peng, +8613671287670, 13671287670@163.com
Shu Wang
About this study
Official title: The Value of Geriatric Assessments in Predicting Treatment Tolerance and Overall Survival in Older Patients With Breast Cancer.
Elderly cancer patients are a special group, often complicated by a variety of chronic diseases, which bring serious obstacles to surgery and adjuvant treatment. It is for these reasons that most patients with high-level evidence-based randomized controlled clinical trials will be part of these patients. Exclusions ultimately lead to a lack of standards for the treatment of elderly breast cancer patients, especially the chemotherapy.
Investigators' purpose was to determine whether geriatric assessments are associated with completion of a chemotherapy course, grade III/IV toxicity or survival in older adults with breast cancer in older patients.
Investigators want to prospectively enroll breast cancer patients with age ≥70 years. By recording the pre-treatment baseline laboratory tests and geriatric assessments, through questionnaires, including Karnofsky performance status(KPS), Eastern Cooperative Oncology Group(ECOG), Mini Nutritional Assessment(MNA), Activity of daily living(ADL), Instrumental activities of daily living(IADL), Mini-Mental State Examination(MMSE), Geriatric Depression Scale(GDS), G-8, Vulnerable Elders Survey-13（VES-13） and FRAIL, Tilburg. Investigators want to learn the relationship between the geriatric assessments and chemotherapy toxicity, chemotherapy completion and overall survival. Establish a model for predicting chemotherapy side effects in old breast cancer patients.
Read the detailed description
Elderly cancer patients are a special group, often complicated by a variety of chronic diseases, which bring serious obstacles to surgery and adjuvant treatment. It is for these reasons that most patients with high-level evidence-based randomized controlled clinical trials will be part of these patients. Exclusions ultimately lead to a lack of standards for the treatment of elderly breast cancer patients, especially the chemotherapy. Numerous studies have shown that older adults are undertreated. This may be, in part, due to concerns about a greater risk of treatment toxicity in older adults.
Investigators' purpose was to determine whether geriatric assessments are associated with completion of a grade III/IV toxicity or survival in older adults with breast cancer in older patients. A predictive model that incorporates geriatric and oncologic correlates of vulnerability to chemotherapy toxicity in older adults could help both the healthcare provider and the patient weigh the benefits and risks of chemotherapy treatment and could serve as a platform to test interventions to decrease the risk of chemotherapy toxicity.
Investigators enroll the breast cancer patients ≥70y，the general data such as age, BMI, hemoglobin, white blood cells, creatinine, albumin, lactate dehydrogenase, blood pressure (diastolic blood pressure) were recorded; comorbidity scores using Charlson's Co-morbidity index（CCI） scores; a wide variety of comprehensive assessment scales for the elderly, after searching previous research and considering the operability of the actual data collected, the KPS, ECOG, MNA, ADL, IADL, MMSE, GDS, G-8, Vulnerable Elders Survey-13（VES-13） and FRAIL, Tilburg assessments were included. The treatment for these participants were decided by their own doctors. The participants who underwent chemotherapy were recorded for their chemotherapy regimen and dosage, and the side effects of chemotherapy were evaluated at the first cycle and after the end of the drug. The surgical methods, pathology after operation, radiotherapy and endocrine therapy also recorded. Long-term follow-up, record the participant's recurrence and recurrence time, cause of death and time. Investigators want to learn the relationship between the geriatric assessments and chemotherapy toxicity, chemotherapy completion and overall survival. Establish a model for predicting chemotherapy side effects in old breast cancer patients.
- Conditions
- Aging, Breast Cancer, Chemotherapeutic Toxicity, Survival
- Keywords
- aging, geriatric assessment, chemotherapy toxicity, overall survival
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of chemotherapy side effects using WHO criteria
evaluation of chemotherapy side effects using WHO criteria after first circle of chemotherapy and the end of all the chemotherapy.The most serious one from the two evaluation will be used for data analysis to study the relationship between geriatric assessment and chemotherapy toxicity.
Measured: two evaluations completed up to 6 months
Secondary outcomes (1)
overall-survival
the time from the date of the initial geriatric assessment until death, censored at the last clinical contact. the relationship between geriatric assessment and overall-survival.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Apr 2018
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shu wang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640117
- Sponsor's protocol ID
- CGAprediting
- Status last verified
- May 2019
- First submitted
- 26 Jul 2018
- Last updated
- 29 May 2019
- 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 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Geriatric Assessments in Predicting Treatment Tolerance and Overall Survival in Older Patients With Breast Cancer.
- ClinicalTrials.gov ID
- NCT03640117
- Acronym / sponsor ID
- CGAprediting
- Conditions
- Aging, Breast Cancer, Chemotherapeutic Toxicity, Survival
- Keywords
- aging, geriatric assessment, chemotherapy toxicity, overall survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 21 Aug 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.
Elderly cancer patients are a special group, often complicated by a variety of chronic diseases, which bring serious obstacles to surgery and adjuvant treatment. It is for these reasons that most patients with high-level evidence-based randomized controlled clinical trials will be part of these patients. Exclusions ultimately lead to a lack of standards for the treatment of elderly breast cancer patients, especially the chemotherapy.
Investigators' purpose was to determine whether geriatric assessments are associated with completion of a chemotherapy course, grade III/IV toxicity or survival in older adults with breast cancer in older patients.
Investigators want to prospectively enroll breast cancer patients with age ≥70 years. By recording the pre-treatment baseline laboratory tests and geriatric assessments, through questionnaires, including Karnofsky performance status(KPS), Eastern Cooperative Oncology Group(ECOG), Mini Nutritional Assessment(MNA), Activity of daily living(ADL), Instrumental activities of daily living(IADL), Mini-Mental State Examination(MMSE), Geriatric Depression Scale(GDS), G-8, Vulnerable Elders Survey-13（VES-13） and FRAIL, Tilburg. Investigators want to learn the relationship between the geriatric assessments and chemotherapy toxicity, chemotherapy completion and overall survival. Establish a model for predicting chemotherapy side effects in old breast cancer patients.
Detailed description
Elderly cancer patients are a special group, often complicated by a variety of chronic diseases, which bring serious obstacles to surgery and adjuvant treatment. It is for these reasons that most patients with high-level evidence-based randomized controlled clinical trials will be part of these patients. Exclusions ultimately lead to a lack of standards for the treatment of elderly breast cancer patients, especially the chemotherapy. Numerous studies have shown that older adults are undertreated. This may be, in part, due to concerns about a greater risk of treatment toxicity in older adults.
Investigators' purpose was to determine whether geriatric assessments are associated with completion of a grade III/IV toxicity or survival in older adults with breast cancer in older patients. A predictive model that incorporates geriatric and oncologic correlates of vulnerability to chemotherapy toxicity in older adults could help both the healthcare provider and the patient weigh the benefits and risks of chemotherapy treatment and could serve as a platform to test interventions to decrease the risk of chemotherapy toxicity.
Investigators enroll the breast cancer patients ≥70y，the general data such as age, BMI, hemoglobin, white blood cells, creatinine, albumin, lactate dehydrogenase, blood pressure (diastolic blood pressure) were recorded; comorbidity scores using Charlson's Co-morbidity index（CCI） scores; a wide variety of comprehensive assessment scales for the elderly, after searching previous research and considering the operability of the actual data collected, the KPS, ECOG, MNA, ADL, IADL, MMSE, GDS, G-8, Vulnerable Elders Survey-13（VES-13） and FRAIL, Tilburg assessments were included. The treatment for these participants were decided by their own doctors. The participants who underwent chemotherapy were recorded for their chemotherapy regimen and dosage, and the side effects of chemotherapy were evaluated at the first cycle and after the end of the drug. The surgical methods, pathology after operation, radiotherapy and endocrine therapy also recorded. Long-term follow-up, record the participant's recurrence and recurrence time, cause of death and time. Investigators want to learn the relationship between the geriatric assessments and chemotherapy toxicity, chemotherapy completion and overall survival. Establish a model for predicting chemotherapy side effects in old breast cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- In this prospective cohort study, patients aged 70 years and older with breast cancer, completed geriatric assessment questionnaire prior to therapy. For patients accepted chemotherapy, toxicity after chemotherapy were recorded using WHO criteria.
Key inclusion criteria (2 listed)
- Confirmed by pathology for breast cancer
- Patients aged 70 years and older
Key exclusion criteria (1 listed)
- Patients with severe mental decline who cannot cooperate with the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluation of chemotherapy side effects using WHO criteria
Time frame: two evaluations completed up to 6 months
evaluation of chemotherapy side effects using WHO criteria after first circle of chemotherapy and the end of all the chemotherapy.The most serious one from the two evaluation will be used for data analysis to study the relationship between geriatric assessment and chemotherapy toxicity.
1 secondary outcome
overall-survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
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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.
shu wang principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Breast Cancer, run by Peking University People's Hospital at 1 site in China.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 May 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yuan peng (+8613671287670, 13671287670@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of chemotherapy side effects using WHO criteria (time frame: two evaluations completed up to 6 months). 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 29 May 2019.