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NCT03466788: EndoQOL

Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer

Completed NA Results posted Last updated 18 December 2025
What this trial tests

NA trial testing Self questionnaires of quality of life and living conditions in Endometrial Cancer in 51 participants. Completed in 28 March 2020.

Timeline
29 March 2018
Primary endpoint
28 March 2019
28 March 2020

Quick facts

Lead sponsorCentre Francois Baclesse
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment51
Start date29 March 2018
Primary completion28 March 2019
Estimated completion28 March 2020
Sites5 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Francois Baclesse — full company profile →

Who can join

18 and older, female only, with Endometrial Cancer or Chemotherapy Effect. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire Primary · 2 years after chemotherapy

The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many clinical trials in oncology. Here is the glodal health status scale of the QLQ-C30 questionnaire, ranging from 0 to 100, with high score indicating good quality of life.

GroupValue95% CI
Patients treated with chemotherapy61.7± 13.2
Patients not treated with chemotherapy71.1± 18.9
Neurotoxicity Induced by Adjuvant Chemotherapy by the CIPN20 Questionnaire Secondary · 2 years after chemotherapy

The quality of life Questionnaire Chemotherapy Induced Peripheral Neuropathy (QLQ-CIPN20) is a questionnaire specifically dedicated to the evaluation of peripheral neuropathies induced by chemotherapy. This quality of life questionnaire is composed of 20 items from 0 to 4 and has been tested in a large international clinical trial. Here is the sensory scale, ranging from 0 to 100, with high scoring indicating high symptom of neuropathy

GroupValue95% CI
Patients treated with chemotherapy20.04± 18.5
Patients not treated with chemotherapy6.86± 11.2
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire Secondary · 2 years after chemotherapy

The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. QLQ-C30 scoring cinludes 5 functionning scales (physical, role, emotional, cognitive and social), ranging from 0 to 100, with high score indicating high level of quality-of-life. QLQ-C30 scoring includes 9 symptom scales (fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties), ranging from 0 to 100, with high score indicating poor level of quality-of-life.

Physical functioning
GroupValue95% CI
Patients treated with chemotherapy75.3± 19
Patients not treated with chemotherapy76.8± 23
Role functioning
GroupValue95% CI
Patients treated with chemotherapy77.2± 24.3
Patients not treated with chemotherapy80.7± 27
Emotional functioning
GroupValue95% CI
Patients treated with chemotherapy67.1± 27
Patients not treated with chemotherapy79.5± 24.6
Cognitive functioning
GroupValue95% CI
Patients treated with chemotherapy76.7± 21.9
Patients not treated with chemotherapy81± 24.3
Social functioning
GroupValue95% CI
Patients treated with chemotherapy75.4± 30.6
Patients not treated with chemotherapy84.6± 24.9
Fatigue
GroupValue95% CI
Patients treated with chemotherapy38.8± 23.8
Patients not treated with chemotherapy22.7± 17.7
Nausea and vomiting
GroupValue95% CI
Patients treated with chemotherapy5.8± 16.5
Patients not treated with chemotherapy8.9± 24.7
Pain
GroupValue95% CI
Patients treated with chemotherapy31.6± 33.7
Patients not treated with chemotherapy25± 25.5
Anxiety by the HADS Questionnaire Secondary · 2 years after chemotherapy

The Hospital Anxiety and Depression Scale (HADS) It is a quick and easy self-questionnaire that assesses both anxious and depressive dimensions (7 items for each dimension). Here is the scale of Anxiety, ranging from 0 to 21, with high score reflecting high level of anxiety.

GroupValue95% CI
Patients treated with chemotherapy9.7± 5.3
Patients not treated with chemotherapy7.7± 4.9
Depression by the HADS Questionnaire Secondary · 2 years after chemotherapy

The Hospital Anxiety and Depression Scale (HADS) It is a quick and easy self-questionnaire that assesses both anxious and depressive dimensions (7 items for each dimension). Here is the depression scale, ranging from 0 to 21, with high score indicating high level of depression.

GroupValue95% CI
Patients treated with chemotherapy5.8± 4.2
Patients not treated with chemotherapy4.9± 3.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years, assessed retrospectively. Patients were included 2 years after their treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients Treated With Chemotherapy
Serious: 0/20 (0%)
Deaths: 0/20
Patients Not Treated With Chemotherapy
Serious: 0/30 (0%)
Deaths: 0/30
Other adverse events (30 terms — click to expand)

ReactionSystemPatients Treated With Chem…Patients Not Treated With …
DIARRHOEAGASTROINTESTINAL DISORDERS
NAUSEAGASTROINTESTINAL DISORDERS
CYSTITISINFECTIONS AND INFESTATIONS
URINARY INCONTINENCERENAL AND URINARY DISORDERS
NEUROPATHY PERIPHERALNERVOUS SYSTEM DISORDERS
ASTHENIAGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
LYMPHOEDEMAVASCULAR DISORDERS
POLLAKIURIARENAL AND URINARY DISORDERS
ABDOMINAL PAINGASTROINTESTINAL DISORDERS
DYSPAREUNIAREPRODUCTIVE SYSTEM AND BREAST DISORDERS
ANAEMIABLOOD AND LYMPHATIC SYSTEM DISORDERS
VOMITINGGASTROINTESTINAL DISORDERS
DYSPNOEARESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RADIATION SKIN INJURYINJURY, POISONING AND PROCEDURAL COMPLICATIONS
PLEURAL EFFUSIONRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
INTERMENSTRUAL BLEEDINGREPRODUCTIVE SYSTEM AND BREAST DISORDERS
VAGINAL INFECTIONINFECTIONS AND INFESTATIONS
PAINGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
RENAL FAILURERENAL AND URINARY DISORDERS
RADIATION PROCTITISINJURY, POISONING AND PROCEDURAL COMPLICATIONS
FEBRILE BONE MARROW APLASIABLOOD AND LYMPHATIC SYSTEM DISORDERS
FATIGUEGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
DEPRESSIONPSYCHIATRIC DISORDERS
ARTHRALGIAMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
THROMBOCYTOPENIABLOOD AND LYMPHATIC SYSTEM DISORDERS
PROCTITISGASTROINTESTINAL DISORDERS
URINARY TRACT INFECTIONINFECTIONS AND INFESTATIONS
PELVIC PAINREPRODUCTIVE SYSTEM AND BREAST DISORDERS
ANAL INFLAMMATIONGASTROINTESTINAL DISORDERS
HAEMORRHOIDSGASTROINTESTINAL DISORDERS

Data from ClinicalTrials.gov NCT03466788 adverse events section.

Sponsor's own description

Through this study, The investigator believe to evaluate the impact in terms of overall quality of life of adjuvant chemotherapy in patients with locally advanced endometrial cancer at a distance from their care

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Endometrial Cancer

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03466788.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing