Breast CancereChemoCoachNCT06424054
Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects
A study testing eChemoCoach in people with Breast Cancer and eHealth, run by Noordwest Ziekenhuisgroep.
Trial summary
Chemotherapy induces side effects varying in severity, impacting patients' quality of life and necessitating unplanned hospital care. Patient-reported outcomes (PROs) could aid in early detection and management of side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, eHealth, Symptom Monitoring
- What is being tested?
- eChemoCoach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 746 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Dec 2029
- Phase
- Interventional
- 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
Who may be able to join
- - Starting (neo)adjuvant treatment with chemotherapy for breast cancer according to one of the below mentioned treatment protocols:
- Four cycles of doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) dose dense q 2 weeks, followed by twelve cycles of weekly paclitaxel 80mg/m2 (also in combination with carboplatin AUC6 q 3 weeks)
- Nine cycles q 3 weeks of paclitaxel 80mg/m2 on day 1 and 8, carboplatin AUC 3 on day 1 and 8, trastuzumab 8mg/kg loading dose (followed by doses of 6mg/m2 at subsequent cycles) on day1 and pertuzumab loading dose of 840mg (followed by doses of 420mg at subsequent cycles) on day 1
- Age ≥ 18 years
- WHO PS ≤1
- Capable of using the EHP or get help in case of low (e-)health literacy. This includes being capable of login using DigiD, a system used by the Dutch government to verify the identity of a person
- Being able to read or get help from a relative in case of illiteracy
Who cannot join
- - Participation in a trial with an investigational product (because more frequent and structured symptom reporting is performed in these studies).
- Patients who have been treated with chemotherapy in the past (since these patients are at higher risk for developing side effects of current chemotherapy).
- Patients that already started with their chemotherapy cycle
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mitigating Toxicity of (Neo)Adjuvant Chemotherapy by Applying Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects: the Prospective Randomized eChemoCoach Trial
Chemotherapy induces side effects varying in severity, impacting patients' quality of life and necessitating unplanned hospital care. Patient-reported outcomes (PROs) could aid in early detection and management of side effects. However, existing PRO monitoring lacks triage capabilities, leading to clinician involvement and suboptimal symptom management. The investigators propose eChemoCoach, an electronic questionnaire integrated into the electronic health portal, offering real-time symptom assessment and personalized advice based on CTCAE criteria. Our study aims to assess the impact of eChemoCoach on non-hematological CTCAE ≥ 3 graded side effects in early breast cancer patients undergoing chemotherapy. This is a randomized controlled trial involving 746 patients that will evaluate the eChemoCoach's efficacy compared to standard monitoring. Phase one will validate questionnaires and assess usability, while phase two focuses on the primary outcome. Te investigators anticipate reduced severe side effects, thereby enhancing patients' quality of life, reducing stress, and minimizing hospital visits.
Read the detailed description
Problem description: The aim of (neo)adjuvant chemotherapy is to increase survival. Therefore, treatment adherence is important. However, patients may experience treatment-related side-effects. In current practice, clinicians evaluate toxicity just a few days before the next chemotherapy is scheduled. Monitoring and timely anticipation of chemotherapy related side-effects may prevent escalation of toxicity, increase treatment adherence and reduce the decline in quality of life. Evaluating toxicity more frequently and on-demand could be a solution to reduce severe toxicity. Therefore, patients should receive a direct advice when experiencing side-effects. However, without interference of a health care professional, this is not possible in standard care.
Solution / research direction: There is increasing evidence that incorporating patient reported outcomes (PROs) in clinical care enhances symptom monitoring in cancer patients. Therefore, it is desirable to develop and investigate an electronic smart-phrased side-effects questionnaire which: 1) delivers a real-time personalized advice to the patient, based on CTCAE grading, after the questionnaire is completed and 2) is accessible for patients using an electronic health portal (EHP) of the electronic health record (EHR) to integrate the PRO data into the EHR.
Aim / hypothesis: To investigate the effect of adding weekly EHP-mediated monitoring of chemotherapy related side-effects based on CTCAE grading using smart-phrased electronic PRO side-effects questionnaires to standard of care monitoring of side-effects, on the occurrence of CTCAE >= grade 3 toxicity.
Plan of investigation: To conduct a pilot study to validate the smart-phrased ePRO side-effects questionnaire. Thereafter, a multicenter clinical randomized trial will start where patients with breast cancer qualifying for (neo)adjuvant chemo(immune)therapy will be randomized to real-time EHP-mediated monitoring of side-effects using a novel smart-phrased ePRO side-effects questionnaire in addition to standard of care monitoring, or to standard of care monitoring solely. Primary objective is the overall rate of CTC grade >=3 non hematological toxicity between both arms. Secondary objectives include relative dose intensity, health-related quality of life, experienced distress, the number of unplanned health care usage and costs.
Expected outcome: The investigators hypothesize that adding weekly EHP-mediated monitoring of side-effects using ePRO side-effects questionnaires will significantly lower the occurrence rate of CTCAE grade >=3 non-hematological toxicities.
- Conditions
- Breast Cancer, eHealth, Symptom Monitoring, Self Management
- Being tested
- eChemoCoach
- Keywords
- Breast Cancer, remote monitoring, emonitoring, eHealth, symptom management, symptom monitoring
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eChemoCoachOther
the eChemoCoach is an electronic questionnaire which is accessible for patients via the secured electronic health portal (EHP) of the EHR, which is CE-certified. By utilizing the eChemoCoach, patients (for this project we focus on breast cancer patients) have the ability to complete a questionnaire on a daily basis, when experiencing side effects. The eChemoCoach has the potential to evaluate the severity of adverse effects based on the CTCAE criteria and triage them, mimicking the decision-making process of a HCP through computer adaptive testing (CAT). Upon completing the questionnaire, the eChemoCoach translates the responses for each specific side effect into corresponding CTCAE grades. The tool then promptly offers patients personalized advice, tailored to their individual condition.
| Study group | Role | What they receive |
|---|---|---|
| eChemoCoach Group | Experimental | Patients assigned to the intervention arm fill in the eChemoCoach questionnaires. They will be asked to report their side effects at baseline (2 - 4 days before their first chemotherapy cycle) and weekly thereafter. Moreover, they can report their symptoms at any time in case of potential toxicity, with a maximum of once a day. Non-responders receive reminders. Both intervention and control groups receive standard monitoring and coaching, including pre-scheduled checks for side effects before chemotherapy. Patients in both groups are asked to complete questionnaires measuring the impact on HRQoL, anxiety, distress, and patient empowerment at baseline, 10 weeks, and 20 weeks post-chemotherapy initiation. Usability of the eChemoCoach will be assessed through an online survey for patients and healthcare professionals using the System Usability Scale Receives: Other: eChemoCoach |
| Control group | No intervention | Patients in the control group receive standard of care. Both intervention and control groups receive standard monitoring and coaching, including pre-scheduled checks for side effects before chemotherapy. Patients in both groups are asked to complete questionnaires measuring the impact on HRQoL, anxiety, distress, and patient empowerment at baseline, 10 weeks, and 20 weeks post-chemotherapy initiation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of any non-hematological side effects grade ≥3
The occurrence of any non-hematological side effects grade ≥3 during neo-adjuvant or adjuvant treatment
Measured: Up to 30 weeks after start chemotherapy
Secondary outcomes (10)
Toxicity patterns
Time to occurrence of both grade 2 and grade ≥3 toxicity will be analyzed with a Kaplan-Meier curves.
Occurrence of grade 2 side effects during (neo)adjuvant will be presented as numbers with percentages for patients in both study groups.
Measured: Up to 30 weeks after start chemotherapy
Relative dose intensity (RDI)
For analyzing the RDI, the RDI will be calculated for each chemotherapeutic agent and presented as mean with standard deviations (SD) (for a description of calculation of the RDI see the objective section paragraph 2.0). The RDI will be calculated per cycle. The RDI will be compared between the intervention and the control group.
Measured: Up to 30 weeks after start chemotherapy
HRQOL
Health-related quality of life measured by the Quality of Life Questionnaire (QLQ-C30s). Scale is ranging from 1 to 4. 1 = not at all, 4 = very much. Higher scores mean a worse QOL.
Measured: on baseline, 10 and 20 weeks after start of chemotherapy
Patient experienced anxiety
Patient experienced anxiety measured using the Hospital Anxiety and Depression Scale. Scale is ranging from 0 to 3. 0 = often, 3 = never. Higher scores means a less worse Hads score.
Measured: on baseline, 10 and 20 weeks after start of chemotherapy
Patient empowerment
Patient empowerment using Patient Activation Measure (PAM13) questionnaire. Ranging from 0 to 3. 0 = I do not agree, 3= I totally agree. A lower score is worse.
Measured: on baseline, 10 and 20 weeks after start of chemotherapy
Patient experienced stress
Patient experienced stress using a distress thermometer. Ranging from 0 to 10 per problem. 0 = no problem, 10 = worst. A higher score means more stress.
Measured: on baseline, 10 and 20 weeks after start of chemotherapy
Unplanned Care
The amount of unplanned hospital care will be presented as median (IQR) and will be analyzed by comparing the number of admissions, unplanned visits, days of hospital admissions between the intervention and control group using Poisson regression analysis.
Measured: Up to 30 weeks after start chemotherapy
Validation of eChemoCoach questionnaires
Cognitive interviews will be analyzed with thematic content analysis. Agreement between professional triage estimations and eChemoCoach will be quantified using Cohen's Kappa coefficient. A semi qualitative assessment will be conducted, comparing the patient-reported adverse effects using eChemoCoach with medical professionals' CTCAE severity assessments. Interviews will be analyzed with thematic content analysis.
Measured: During the first year of the study
Usability
The System Usability Scale will be used for global assessment of the eChemoCoach. usability. Usability will also be assessed by healthcare professionals from participating. sites. The SUS is a 10 item questionnaire with 5 response options. Ranging from strongly disagree to strongly agree. The average SUS score from all 500 studies is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Measured: After inclusion of all intervention patients
Agreement eChemoCoach-reported grades and those reported by PRO-CTCAE, HCPs, and the Dutch translation of CTCAE
To assess the concordance among eChemoCoach-reported grades, PRO-CTCAE, and CTCAEs graded by healthcare professionals (HCPs), we employ the eChemoCoach platform for patient experienced symptom data collection. Each questionnaire administered includes the eChemoCoach and the PRO-CTCAE questionnaire, facilitating immediate and direct comparison of both outcomes. HCPs will document symptom grading in patient files using standardized CTCAE forms. HCPs will grade the severity on pre-planned checks (standard of care) and when necessary in case of severe side effects.
Measured: Up to 30 weeks after start chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A clinical randomized controlled trial will be performed in 746 breast cancer patients treated with (neo-)adjuvant chemotherapy. Patients will be randomized to the intervention group, using the eChemoCoach in addition to standard of care monitoring to manage side effects or are randomized to solely standard of care monitoring.
- Masking
- None (open label)
- Enrolment
- 746 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noordwest Ziekenhuisgroep
- Sponsor type
- University, hospital or other
- Collaborators
- Comprehensive Cancer Centre The Netherlands, University of Twente, Dutch Cancer Society, Borstkanker Onderzoek Groep
- Responsible party
- Principal investigator, Mathijs Hendriks, MD, Noordwest Ziekenhuisgroep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424054
- Sponsor's protocol ID
- 2023-01/15741 (KWF-grant)
- Acronym
- eChemoCoach
- Status last verified
- May 2024
- First submitted
- 9 Apr 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Verduin RJT, van den Hurk CJG, van Maurik IS, Nota NM, van Leeuwen-Stok AE, Komen MMC, Jager A, Drossaert CHC, Siesling S, Hendriks MP. Interactive symptom monitoring and coaching to optimise toxicity management of chemo(immune)therapy in early stage breast cancer: study protocol of the multicentre randomised controlled eChemoCoach trial. BMC Cancer. 2026 Mar 26;26(1):571. doi: 10.1186/s12885-026-15905-7.
PubMed 41888754
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Toxicity of (Neo)Adjuvant Chemotherapy by Applying Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects: the Prospective Randomized eChemoCoach Trial
- ClinicalTrials.gov ID
- NCT06424054
- Acronym / sponsor ID
- eChemoCoach / 2023-01/15741 (KWF-grant)
- Conditions
- Breast Cancer, eHealth, Symptom Monitoring, Self Management
- Keywords
- Breast Cancer, remote monitoring, emonitoring, eHealth, symptom management, symptom monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 746 participants (estimated)
- Lead sponsor
- Noordwest ZiekenhuisgroepUniversity, hospital or other
- Collaborators
- Comprehensive Cancer Centre The Netherlands, University of Twente, Dutch Cancer Society, Borstkanker Onderzoek Groep
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 21 May 2024 (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.
Chemotherapy induces side effects varying in severity, impacting patients' quality of life and necessitating unplanned hospital care. Patient-reported outcomes (PROs) could aid in early detection and management of side effects. However, existing PRO monitoring lacks triage capabilities, leading to clinician involvement and suboptimal symptom management. The investigators propose eChemoCoach, an electronic questionnaire integrated into the electronic health portal, offering real-time symptom assessment and personalized advice based on CTCAE criteria. Our study aims to assess the impact of eChemoCoach on non-hematological CTCAE ≥ 3 graded side effects in early breast cancer patients undergoing chemotherapy. This is a randomized controlled trial involving 746 patients that will evaluate the eChemoCoach's efficacy compared to standard monitoring. Phase one will validate questionnaires and assess usability, while phase two focuses on the primary outcome. Te investigators anticipate reduced severe side effects, thereby enhancing patients' quality of life, reducing stress, and minimizing hospital visits.
Detailed description
Problem description: The aim of (neo)adjuvant chemotherapy is to increase survival. Therefore, treatment adherence is important. However, patients may experience treatment-related side-effects. In current practice, clinicians evaluate toxicity just a few days before the next chemotherapy is scheduled. Monitoring and timely anticipation of chemotherapy related side-effects may prevent escalation of toxicity, increase treatment adherence and reduce the decline in quality of life. Evaluating toxicity more frequently and on-demand could be a solution to reduce severe toxicity. Therefore, patients should receive a direct advice when experiencing side-effects. However, without interference of a health care professional, this is not possible in standard care.
Solution / research direction: There is increasing evidence that incorporating patient reported outcomes (PROs) in clinical care enhances symptom monitoring in cancer patients. Therefore, it is desirable to develop and investigate an electronic smart-phrased side-effects questionnaire which: 1) delivers a real-time personalized advice to the patient, based on CTCAE grading, after the questionnaire is completed and 2) is accessible for patients using an electronic health portal (EHP) of the electronic health record (EHR) to integrate the PRO data into the EHR.
Aim / hypothesis: To investigate the effect of adding weekly EHP-mediated monitoring of chemotherapy related side-effects based on CTCAE grading using smart-phrased electronic PRO side-effects questionnaires to standard of care monitoring of side-effects, on the occurrence of CTCAE >= grade 3 toxicity.
Plan of investigation: To conduct a pilot study to validate the smart-phrased ePRO side-effects questionnaire. Thereafter, a multicenter clinical randomized trial will start where patients with breast cancer qualifying for (neo)adjuvant chemo(immune)therapy will be randomized to real-time EHP-mediated monitoring of side-effects using a novel smart-phrased ePRO side-effects questionnaire in addition to standard of care monitoring, or to standard of care monitoring solely. Primary objective is the overall rate of CTC grade >=3 non hematological toxicity between both arms. Secondary objectives include relative dose intensity, health-related quality of life, experienced distress, the number of unplanned health care usage and costs.
Expected outcome: The investigators hypothesize that adding weekly EHP-mediated monitoring of side-effects using ePRO side-effects questionnaires will significantly lower the occurrence rate of CTCAE grade >=3 non-hematological toxicities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A clinical randomized controlled trial will be performed in 746 breast cancer patients treated with (neo-)adjuvant chemotherapy. Patients will be randomized to the intervention group, using the eChemoCoach in addition to standard of care monitoring to manage side effects or are randomized to solely standard of care monitoring.
| Arm | Type | Receives |
|---|---|---|
| eChemoCoach Group | Experimental | Other: eChemoCoachPatients assigned to the intervention arm fill in the eChemoCoach questionnaires. They will be asked to report their side effects at baseline (2 - 4 days before their first chemotherapy cycle) and weekly thereafter. Moreover, they can report their symptoms at any time in case of potential toxicity, with a maximum of once a day. Non-responders receive reminders. Both intervention and control groups receive standard monitoring and coaching, including pre-scheduled checks for side effects before chemotherapy. Patients in both groups are asked to complete questionnaires measuring the impact on HRQoL, anxiety, distress, and patient empowerment at baseline, 10 weeks, and 20 weeks post-chemotherapy initiation. Usability of the eChemoCoach will be assessed through an online survey for patients and healthcare professionals using the System Usability Scale |
| Control group | No intervention | –Patients in the control group receive standard of care. Both intervention and control groups receive standard monitoring and coaching, including pre-scheduled checks for side effects before chemotherapy. Patients in both groups are asked to complete questionnaires measuring the impact on HRQoL, anxiety, distress, and patient empowerment at baseline, 10 weeks, and 20 weeks post-chemotherapy initiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- - Starting (neo)adjuvant treatment with chemotherapy for breast cancer according to one of the below mentioned treatment protocols:
- Age ≥ 18 years
- WHO PS ≤1
- Capable of using the EHP or get help in case of low (e-)health literacy. This includes being capable of login using DigiD, a system used by the Dutch government to verify the identity of a person
- Being able to read or get help from a relative in case of illiteracy
Key exclusion criteria (3 listed)
- - Participation in a trial with an investigational product (because more frequent and structured symptom reporting is performed in these studies).
- Patients who have been treated with chemotherapy in the past (since these patients are at higher risk for developing side effects of current chemotherapy).
- Patients that already started with their chemotherapy cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eChemoCoachthe eChemoCoach is an electronic questionnaire which is accessible for patients via the secured electronic health portal (EHP) of the EHR, which is CE-certified. By utilizing the eChemoCoach, patients (for this project we focus on breast cancer patients) have the ability to complete a questionnaire on a daily basis, when experiencing side effects. The eChemoCoach has the potential to evaluate the severity of adverse effects based on the CTCAE criteria and triage them, mimicking the decision-making process of a HCP through computer adaptive testing (CAT). Upon completing the questionnaire, the eChemoCoach translates the responses for each specific side effect into corresponding CTCAE grades. The tool then promptly offers patients personalized advice, tailored to their individual condition. | Other | eChemoCoach Group |
Primary outcome
The occurrence of any non-hematological side effects grade ≥3
Time frame: Up to 30 weeks after start chemotherapy
The occurrence of any non-hematological side effects grade ≥3 during neo-adjuvant or adjuvant treatment
10 secondary outcomes
Toxicity patterns
Time frame: Up to 30 weeks after start chemotherapy
Relative dose intensity (RDI)
Time frame: Up to 30 weeks after start chemotherapy
HRQOL
Time frame: on baseline, 10 and 20 weeks after start of chemotherapy
Patient experienced anxiety
Time frame: on baseline, 10 and 20 weeks after start of chemotherapy
Patient empowerment
Time frame: on baseline, 10 and 20 weeks after start of chemotherapy
Patient experienced stress
Time frame: on baseline, 10 and 20 weeks after start of chemotherapy
Unplanned Care
Time frame: Up to 30 weeks after start chemotherapy
Validation of eChemoCoach questionnaires
Time frame: During the first year of the study
Usability
Time frame: After inclusion of all intervention patients
Agreement eChemoCoach-reported grades and those reported by PRO-CTCAE, HCPs, and the Dutch translation of CTCAE
Time frame: Up to 30 weeks after start chemotherapy
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 21 May 2024.
- Derived from this study: PubMed 41888754Verduin RJT, van den Hurk CJG, van Maurik IS, Nota NM, van Leeuwen-Stok AE, Komen MMC, Jager A, Drossaert CHC, Siesling S, Hendriks MP. Interactive symptom monitoring and coaching to optimise toxicity management of chemo(immune)therapy in early stage breast cancer: study protocol of the multicentre randomised controlled eChemoCoach trial. BMC Cancer. 2026 Mar 26;26(1):571. doi: 10.1186/s12885-026-15905-7.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing eChemoCoach in people with Breast Cancer and eHealth, run by Noordwest Ziekenhuisgroep.
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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Manon Hanrath-Komen, PhD (0031 72 5482872, m.m.c.komen@nwz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of any non-hematological side effects grade ≥3 (time frame: Up to 30 weeks after start chemotherapy). 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 NCT06424054, which also lists 1 linked publication.
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 21 May 2024.