Clinical trial · Observational
QoLIDia: Quality of Life in Cancer Patients With Diabetes During Immunotherapy
Impact of Concurrent Diabetes on Quality-of-life Changes During Immunotherapy - A Prospective Longitudinal Study
NCT07466212CI-TRIAL-00105345QoLIDianot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Type 2 Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients with type 2 diabetes
- description
- The patients have cancer and receive immunotherapy
- label
- Patients without diabetes
- description
- The patients have cancer and receive immunotherapy
Primary outcomes (1)
- measure
- Change in EORTC QLQ-C30 Global Health Status score
- timeFrame
- Baseline, 3 months and 6 months
- description
- 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.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (4)
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDBrahmer JR, Abu-Sbeih H, Ascierto PA, Brufsky J, Cappelli LC, Cortazar FB, Gerber DE, Hamad L, Hansen E, Johnson DB, Lacouture ME, Masters GA, Naidoo J, Nanni M, Perales MA, Puzanov I, Santomasso BD, Shanbhag SP, Sharma R, Skondra D, Sosman JA, Turner M, Ernstoff MS. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events. J Immunother Cancer. 2021 Jun;9(6):e002435. doi: 10.1136/jitc-2021-002435. PMID 34172516
- BACKGROUNDCortellini A, D'Alessio A, Cleary S, Buti S, Bersanelli M, Bordi P, Tonini G, Vincenzi B, Tucci M, Russo A, Pantano F, Russano M, Stucci LS, Sergi MC, Falconi M, Zarzana MA, Santini D, Spagnolo F, Tanda ET, Rastelli F, Giorgi FC, Pergolesi F, Giusti R, Filetti M, Lo Bianco F, Marchetti P, Botticelli A, Gelibter A, Siringo M, Ferrari M, Marconcini R, Vitale MG, Nicolardi L, Chiari R, Ghidini M, Nigro O, Grossi F, De Tursi M, Di Marino P, Queirolo P, Bracarda S, Macrini S, Inno A, Zoratto F, Veltri E, Spoto C, Vitale MG, Cannita K, Gennari A, Morganstein DL, Mallardo D, Nibid L, Sabarese G, Brunetti L, Perrone G, Ascierto PA, Ficorella C, Pinato DJ. Type 2 Diabetes Mellitus and Efficacy Outcomes from Immune Checkpoint Blockade in Patients with Cancer. Clin Cancer Res. 2023 Jul 14;29(14):2714-2724. doi: 10.1158/1078-0432.CCR-22-3116. PMID 37125965
- BACKGROUNDSharma P, Allison JP. Immune checkpoint targeting in cancer therapy: toward combination strategies with curative potential. Cell. 2015 Apr 9;161(2):205-14. doi: 10.1016/j.cell.2015.03.030. PMID 25860605