The Role of FRAIL and FIND Frailty Scales in Predicting Chemotherapy-Related Toxicity Among Older Adults Receiving Adjuvant Treatment for Gastrointestinal Cancers: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Association Between Baseline Frailty Scores (FRAIL and FiND) and the Incidence of Grade ≥3 Chemotherapy-Related Toxicity
研究概览
简要总结
This observational study evaluated whether two frailty screening tools, the FRAIL scale and the FiND questionnaire, can predict chemotherapy-related side effects in older adults with gastrointestinal cancers. Patients aged 65 years or older who received standard adjuvant chemotherapy after curative surgery for cancers of the colon, rectum, stomach, pancreas, or esophagus were included. No experimental treatment was given, and all patients received routine chemotherapy determined by their treating oncologists.
Frailty was assessed at the beginning of chemotherapy, around the middle of treatment, and at the end of therapy. Side effects were recorded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The main goal was to determine whether baseline frailty scores were associated with severe (Grade 3 or higher) chemotherapy toxicity. Additional goals included understanding how nutritional status, performance status, and comorbidities were related to toxicity and treatment completion.
The study collected real-world data to help identify older patients at higher risk of toxicity and to support safer, more personalized decision-making in routine oncology practice.
详细描述
This prospective observational study evaluated the relationship between frailty and chemotherapy-related toxicity in older adults with gastrointestinal cancers. Frailty was assessed using two validated screening tools: the FRAIL scale and the FiND questionnaire. Both tools are short, patient-reported screening instruments designed to identify vulnerability, reduced physiological reserve, and early mobility limitations in older adults. Both frailty instruments (FRAIL and FiND) have validated Turkish-language versions, ensuring cultural and linguistic appropriateness for use in older adults in Turkey.
Frailty Assessment Instruments
1. FRAIL Scale (Score Range: 0-5)
The FRAIL scale includes five items (Fatigue, Resistance, Ambulation, Illness, and Loss of weight).
Each item scores 1 point for "Yes" and 0 points for "No":
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years
- •Histologically confirmed gastrointestinal (GI) malignancy, including: Colorectal adenocarcinoma (colon or rectum), Gastric adenocarcinoma, Pancreatic adenocarcinoma, Biliary tract cancer (cholangiocarcinoma, gallbladder cancer) Small intestine adenocarcinoma, Esophageal cancer (adenocarcinoma or squamous cell carcinoma)
- •Completion of curative-intent surgery with a postoperative plan for adjuvant chemotherapy.
- •Receipt of standard adjuvant chemotherapy, including (but not limited to): FOLFOX, CAPOX (XELOX), Capecitabine monotherapy, FOLFIRINOX (selected fit older adults only), Gemcitabine ± capecitabine
- •Initiation of adjuvant chemotherapy within the study period.
- •Baseline frailty assessment (FRAIL Scale and FiND questionnaire) completed before the first chemotherapy cycle.
- •Ability to provide informed consent and comply with frailty and toxicity follow-up assessments.
排除标准
- •Age <65 years.
- •Metastatic, recurrent, or unresectable disease at the time of adjuvant treatment.
- •Receiving neoadjuvant-only treatment without subsequent adjuvant chemotherapy.
- •Non-adenocarcinoma GI malignancies treated with protocols outside standard adjuvant chemotherapy (e.g., GIST receiving adjuvant imatinib; neuroendocrine tumors).
- •Prior chemotherapy within 12 months for another malignancy.
- •Missing baseline frailty assessment (FRAIL or FiND).
- •Missing toxicity follow-up after chemotherapy initiation.
- •Severe cognitive impairment, advanced dementia, or psychiatric illness preventing reliable questionnaire completion.
- •Concurrent participation in another interventional clinical trial that may alter chemotherapy toxicity or functional outcomes.
结局指标
主要结局
Association Between Baseline Frailty Scores (FRAIL and FiND) and the Incidence of Grade ≥3 Chemotherapy-Related Toxicity
时间窗: From baseline (before the first chemotherapy cycle) through every chemotherapy cycle during the adjuvant regimen, with summary toxicity assessments performed at mid-treatment (~3 months) and at treatment completion (~6 months).
This outcome examines whether baseline frailty, analyzed separately using the FRAIL Scale and the FiND Questionnaire, is associated with the development of severe chemotherapy-related toxicity. Toxicities were classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, where Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 = death. Frailty Instruments: FRAIL Scale (Fatigue, Resistance, Ambulation, Illness, Loss of Weight): score range 0-5; higher scores indicate worse frailty. FiND Questionnaire (Frailty and Mobility Disability): score range 0-5; higher scores indicate worse frailty or mobility disability. Each frailty score will be analyzed independently for its association with severe chemotherapy-related toxicity.
次要结局
- Change in FRAIL (Fatigue, Resistance, Ambulation, Illness, Loss of Weight) Scale Score Over Time(Baseline, 3 months, and 6 months.)
- Change in FIND (Frailty and Mobility Disability) Questionnaire Score Over Time(Baseline, 3 months, and 6 months.)
- Correlation Between FRAIL Scale and FIND Questionnaire Scores(Baseline, 3 months, and 6 months.)
- Change in Mini Nutritional Assessment-Short Form (MNA-SF) Score Over Time(Baseline, 3 months, and 6 months.)
- Incidence of Chemotherapy-Related Toxicity Categories Classified by CTCAE Version 5.0(From first chemotherapy cycle to end of treatment (~6 months).)
- Association Between Changes in Frailty Scores and Development of Grade ≥3 Toxicity(Baseline to 6 months.)
- Proportion of Participants Completing All Planned Adjuvant Chemotherapy Cycles(End of planned adjuvant chemotherapy (~6 months).)
- Incidence of Chemotherapy Treatment Modifications(From first chemotherapy cycle through the end of treatment (up to 6 months).)
- Correlation Between FRAIL Scale Score and Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline)
- Correlation Between FRAIL Scale Score and the Modified Charlson Comorbidity Index (mCCI)(Baseline)
- Predictive Performance of Baseline FRAIL Score for Grade ≥3 Toxicity(Baseline through 6 months.)
- Predictive Performance of Baseline FiND Score for Grade ≥3 Toxicity(Baseline through 6 months.)
- Association Between Changes in FIND Questionnaire Score and Development of Grade ≥3 Toxicity(Baseline to 6 months.)
- Correlation Between FiND Questionnaire Score and Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline.)
- Correlation Between FIND Questionnaire Score and the Modified Charlson Comorbidity Index (mCCI)(Baseline)
研究者
Galip Can Uyar
MD
Ankara Etlik City Hospital