The Value of Geriatric Assessments in Older Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

The Value of Geriatric Assessments in Predicting Treatment Tolerance and Overall Survival in Older Patients With Breast Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03640117
• Other study ID #: CGAprediting
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2019
• Source: Peking University People's Hospital
• Contact: yuan peng
• Phone: +8613671287670
• Email: 13671287670[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Confirmed by pathology for breast cancer

• Patients aged 70 years and older

Exclusion Criteria:

• Patients with severe mental decline who cannot cooperate with the questionnaire

Related Conditions & MeSH terms

• Aging
• Breast Cancer
• Breast Neoplasms
• Chemotherapeutic Toxicity
• Survival

Locations

Country	Name	City	State
China	Peking university people's hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two evaluations completed up to 6 months
Secondary	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.	5 years