Impact of Concurrent Diabetes on Quality-of-life Changes During Immunotherapy - A Prospective Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 920
- 试验地点
- 4
- 主要终点
- Change in EORTC QLQ-C30 Global Health Status score
研究概览
简要总结
The goal of this observational study is to see how type 2 diabetes affects quality of life in cancer patients receiving immunotherapy. We want to know if patients with diabetes have a greater decline in quality of life over six months compared to those without. The main question we aim to answer is:
- How does quality of life change over six months in patients with versus without diabetes?
Participants will complete quality-of-life surveys at the start, then at 3 and 6 months. This will help us see if diabetes adds extra challenges during cancer treatment
详细描述
Immune checkpoint inhibitors (ICIs) have transformed the management of multiple solid malignancies by improving survival and enabling durable disease control. By targeting inhibitory immune checkpoints such as PD-1, PD-L1, and CTLA-4, these therapies enhance anti-tumour immune responses. However, immune activation may also result in immune-related adverse events (irAEs), which can affect multiple organ systems and range from mild to life-threatening. As survival improves, long-term and chronic toxicities are increasingly recognised, highlighting the importance of patient-centred outcomes such as health-related quality of life (HRQoL).
Diabetes mellitus (DM) is a common comorbidity among patients with cancer and is associated with increased symptom burden, functional impairment, and reduced HRQoL. Type 2 diabetes (T2D) has also been associated with adverse cancer outcomes and may influence both the effectiveness and toxicity profile of systemic anticancer therapy, including ICIs. In addition, ICIs can induce immune-related diabetes mellitus (ir-DM), a rare but clinically significant form of new-onset insulin-dependent diabetes requiring lifelong insulin treatment. Despite its clinical relevance, the interaction between pre-existing diabetes, ICI therapy, and longitudinal HRQoL remains insufficiently characterised.
Although HRQoL is generally reported to remain stable during ICI therapy in unselected cancer populations, it is unknown whether similar patterns are observed in patients with pre-existing DM or in those who develop ir-DM during treatment. Given the metabolic, functional, and psychosocial burden associated with diabetes, this patient group may be particularly vulnerable to deterioration in HRQoL during immunotherapy.
The primary aim of this study is to compare longitudinal changes in HRQoL between patients with T2D and non-diabetic patients from baseline to 3 and 6 months after initiation of ICI therapy. The primary hypothesis is that patients with T2D will experience a greater decline in HRQoL over the first six months of treatment compared with non-diabetic patients.
This is a prospective, multicentre cohort study of adult cancer patients initiating ICI therapy. Data will be collected prospectively using a secure electronic case report form across participating centres.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Histologically confirmed solid malignant tumor.
- •Planned treatment with ICI monotherapy or dual-ICI combination therapy (metastatic, adjuvant, or neo-adjuvant settings).
- •Previous systemic anticancer therapy other than ICI is allowed.
- •Ability and willingness to provide written informed consent and to complete HRQoL questionnaires.
- •Sufficient Danish language proficiency to read, and complete study questionnaires.
排除标准
- •Previous ICI treatment within 6 months.
- •Concurrent systemic anticancer therapy other than ICI.
- •Declines or does not provide informed consent.
- •Cognitive or physical impairment preventing valid consent or completion of patient-reported outcomes.
研究组 & 干预措施
Patients with type 2 diabetes
The patients have cancer and receive immunotherapy
Patients without diabetes
The patients have cancer and receive immunotherapy
结局指标
主要结局
Change in EORTC QLQ-C30 Global Health Status score
时间窗: Baseline, 3 months and 6 months
Change in health-related quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status scale. Scores range from 0 to 100, with higher scores indicating better global quality of life. The outcome compares changes from baseline between patients with type 2 diabetes and patients without diabetes receiving immune checkpoint inhibitor (ICI) therapy.
次要结局
- Change in EQ-5D-5L Index Value(Baseline to 3 months and 6 months)
- Change in EQ-5D-5L Visual Analogue Scale (EQ-VAS) score(Baseline, 3 months and 6 months)
- Incidence of immune-related diabetes mellitus(Within 12 months after initiation of ICI.)
- Hospital Admissions(Within 6 months after initiation of ICI therapy.)
- Time to Treatment Failure(Within 6 months after initiation of immune checkpoint inhibitor therapy)
- Time to death from any cause (Overall Survival)(Within 12 months after initiation of immune checkpoint inhibitor therapy)
- Association Between Clinical Events and HRQoL Outcomes(Baseline to 6 months)
- Change in Problem Areas in Diabetes Score(Baseline to 6 months (assessed at baseline, 3 months, and 6 months))
研究者
Debbie Maria Madsen
Principal Investigator
Odense University Hospital