CancerQoLIDiaNCT07466212
QoLIDia: Quality of Life in Cancer Patients With Diabetes During Immunotherapy
An observational study of Cancer and Type 2 Diabetes, run by Odense University Hospital at 4 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Type 2 Diabetes
- How many people
- 920 participants
- Where
- 4 sitesDenmark
- Study dates
- 18 Mar 2026to 1 Oct 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with solid malignancies initiating immune checkpoint inhibitor therapy in routine clinical practice, with and without pre-existing type 2 diabetes.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites, 4 recruiting
- Not yet recruiting
Onkologisk afdeling, Klinik Kirurgi og Kræftbehandling
Aalborg, 9000
Maria Skovborg, MD, +45 97661409, maria.skovborg@rn.dk
Maria Skovborg, MD
- Recruiting
Kræftafdelingen, Aarhus Universitetshospital
Aarhus, 8000
Rasmus B Friis, MD, phd, rasmus.friis@auh.rm.dk
Rasmus B Friis, MD, PhD
- Recruiting
Afdeling for Kræftbehandling, Herlev Hospital
Herlev, 2730
Eva E Steensgaard, MD, phd, eva.ellebaek.steensgaard@regionh.dk
- Recruiting
Sygehus Lillebælt, Onkologisk afdeling Vejle
Vejle, 7100
Julie Stougaard, MD, 2912 3819, Julie.Stougaard@rsyd.dk
Julie Stougaard, MD
About this study
Official title: Impact of Concurrent Diabetes on Quality-of-life Changes During Immunotherapy - A Prospective Longitudinal Study
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
Read the detailed description
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.
At baseline, demographic characteristics, cancer type and stage, treatment intent and planned ICI regimen, diabetes status (no diabetes, type 1 diabetes, or type 2 diabetes), diabetes treatment status, performance status, and baseline patient-reported outcomes will be recorded.
During follow-up, data will be collected on ICI exposure, treatment discontinuation and reasons for discontinuation, immune-related adverse events, hospitalisations, disease progression, survival status, and the occurrence of immune-related diabetes mellitus.
Patient-reported outcomes will be assessed using the EORTC QLQ-C30 and EQ-5D-5L questionnaires in all participants, and the PAID questionnaire in participants with diabetes. Assessments will be performed at baseline and at 3 and 6 months after treatment initiation.
Immune-related diabetes mellitus will be defined as new-onset insulin-dependent diabetes occurring after initiation of ICI therapy and consistent with marked beta-cell failure, classified according to established international clinical recommendations.
This study will provide prospective real-world data on HRQoL trajectories and survival among cancer patients with and without diabetes receiving ICI therapy, and will estimate the incidence and clinical characteristics of immune-related diabetes mellitus in a nationwide setting.
- Conditions
- Cancer, Type 2 Diabetes
- Keywords
- Type 2 diabetes, Cancer, Immunotherapy, Quality of life, Patient-reported outcomes, Real-world study
- Medical subject headings
- Neoplasms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes | The patients have cancer and receive immunotherapy | |
| Patients without diabetes | The patients have cancer and receive immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EORTC QLQ-C30 Global Health Status score
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.
Measured: Baseline, 3 months and 6 months
Secondary outcomes (8)
Change in EQ-5D-5L Index Value
Health status measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The index value is derived from the five EQ-5D dimensions using a population value set, where higher values indicate better health status.
Measured: Baseline to 3 months and 6 months
Change in EQ-5D-5L Visual Analogue Scale (EQ-VAS) score
Self-rated health measured using the EQ-5D-5L visual analogue scale (EQ-VAS), where participants rate their health from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Baseline, 3 months and 6 months
Incidence of immune-related diabetes mellitus
Incidence of immune-related diabetes mellitus within 12 months of ICI initiation (number and proportion). Record occurrence of diabetic ketoacidosis at immune-related diabetes mellitus onset.
Measured: Within 12 months after initiation of ICI.
Hospital Admissions
Number and type of hospital admissions within 6 months of ICI initiation, categorized Immune-related adverse event related, diabetes-related, or other. Derived measures include time to first hospitalization and length of stay.
Measured: Within 6 months after initiation of ICI therapy.
Time to Treatment Failure
Time from first dose of immune checkpoint inhibitor (ICI) therapy to permanent discontinuation of ICI therapy for any reason (including disease progression, toxicity, or other causes) or death, whichever occurs first.
Measured: Within 6 months after initiation of immune checkpoint inhibitor therapy
Time to death from any cause (Overall Survival)
Overall survival defined as time from initiation of ICI therapy to death from any cause.
Measured: Within 12 months after initiation of immune checkpoint inhibitor therapy
Association Between Clinical Events and HRQoL Outcomes
Exploratory analyses examining associations between clinical events (e.g., hospitalizations and immune-related adverse events) and changes 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). Scores range from 0 to 100, with higher scores indicating better global health status and quality of life.
Measured: Baseline to 6 months
Change in Problem Areas in Diabetes Score
Change in diabetes-related emotional distress measured by the Problem Areas in Diabetes (PAID) questionnaire. The PAID questionnaire assesses diabetes-specific emotional distress, with higher scores indicating greater distress. This outcome is assessed in participants with diabetes.
Measured: Baseline to 6 months (assessed at baseline, 3 months, and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start18 Mar 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Odense University 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
- 920 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina B Ruhlmann, MD, PhD, Study chair, Onkologisk afd R, OUHDebbie M Madsen, MD, Principal investigator, Onkologisk afd R, OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466212
- Sponsor's protocol ID
- QoLIDia
- Acronym
- QoLIDia
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aaronson 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.
PubMed 8433390Brahmer 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.
PubMed 34172516Cortellini 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.
PubMed 37125965Sharma 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.
PubMed 25860605
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Concurrent Diabetes on Quality-of-life Changes During Immunotherapy - A Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT07466212
- Acronym / sponsor ID
- QoLIDia / QoLIDia
- Conditions
- Cancer, Type 2 Diabetes
- Keywords
- Type 2 diabetes, Cancer, Immunotherapy, Quality of life, Patient-reported outcomes, Real-world study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 920 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 12 Mar 2026 (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.
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
Detailed description
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.
At baseline, demographic characteristics, cancer type and stage, treatment intent and planned ICI regimen, diabetes status (no diabetes, type 1 diabetes, or type 2 diabetes), diabetes treatment status, performance status, and baseline patient-reported outcomes will be recorded.
During follow-up, data will be collected on ICI exposure, treatment discontinuation and reasons for discontinuation, immune-related adverse events, hospitalisations, disease progression, survival status, and the occurrence of immune-related diabetes mellitus.
Patient-reported outcomes will be assessed using the EORTC QLQ-C30 and EQ-5D-5L questionnaires in all participants, and the PAID questionnaire in participants with diabetes. Assessments will be performed at baseline and at 3 and 6 months after treatment initiation.
Immune-related diabetes mellitus will be defined as new-onset insulin-dependent diabetes occurring after initiation of ICI therapy and consistent with marked beta-cell failure, classified according to established international clinical recommendations.
This study will provide prospective real-world data on HRQoL trajectories and survival among cancer patients with and without diabetes receiving ICI therapy, and will estimate the incidence and clinical characteristics of immune-related diabetes mellitus in a nationwide setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | – | –The patients have cancer and receive immunotherapy |
| Patients without diabetes | – | –The patients have cancer and receive immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with solid malignancies initiating immune checkpoint inhibitor therapy in routine clinical practice, with and without pre-existing type 2 diabetes.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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
Change in EORTC QLQ-C30 Global Health Status score
Time frame: 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.
8 secondary outcomes
Change in EQ-5D-5L Index Value
Time frame: Baseline to 3 months and 6 months
Change in EQ-5D-5L Visual Analogue Scale (EQ-VAS) score
Time frame: Baseline, 3 months and 6 months
Incidence of immune-related diabetes mellitus
Time frame: Within 12 months after initiation of ICI.
Hospital Admissions
Time frame: Within 6 months after initiation of ICI therapy.
Time to Treatment Failure
Time frame: Within 6 months after initiation of immune checkpoint inhibitor therapy
Time to death from any cause (Overall Survival)
Time frame: Within 12 months after initiation of immune checkpoint inhibitor therapy
Association Between Clinical Events and HRQoL Outcomes
Time frame: Baseline to 6 months
Change in Problem Areas in Diabetes Score
Time frame: Baseline to 6 months (assessed at baseline, 3 months, and 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 8433390Aaronson 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.
- Background: PubMed 34172516Brahmer 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.
- Background: PubMed 37125965Cortellini 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.
- Background: PubMed 25860605Sharma 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.
- Individual participant dataSharing planned: No
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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.
Christina B Ruhlmann, MD, PhD study chair
Onkologisk afd R, OUH
Debbie M Madsen, MD principal investigator
Onkologisk afd R, OUH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Type 2 Diabetes, run by Odense University Hospital at 4 sites in Denmark.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debbie Maria Madsen, MD (+45 29801558, debbie.maria.madsen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EORTC QLQ-C30 Global Health Status score (time frame: Baseline, 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466212, which also lists 4 linked publications.
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 22 Oct 2026.