Trial Outcomes & Findings for Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer (NCT NCT03466788)
NCT ID: NCT03466788
Last Updated: 2025-12-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
2 years after chemotherapy
Results posted on
2025-12-18
Participant Flow
Participant milestones
| Measure |
Patients Treated With Chemotherapy
Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy.
|
Patients Not Treated With Chemotherapy
Control patients received only surgery and radiotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
30
|
|
Overall Study
COMPLETED
|
20
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Treated With Chemotherapy
n=20 Participants
Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy.
|
Patients Not Treated With Chemotherapy
n=30 Participants
Control patients received only surgery and radiotherapy.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 9 • n=20 Participants
|
69.6 years
STANDARD_DEVIATION 10 • n=30 Participants
|
67.9 years
STANDARD_DEVIATION 9.6 • n=50 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
30 Participants
n=30 Participants
|
50 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
WHO performance status
0
|
16 Participants
n=20 Participants
|
24 Participants
n=30 Participants
|
40 Participants
n=50 Participants
|
|
WHO performance status
1
|
2 Participants
n=20 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=50 Participants
|
|
WHO performance status
2
|
1 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=50 Participants
|
|
WHO performance status
Unknown
|
1 Participants
n=20 Participants
|
4 Participants
n=30 Participants
|
5 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 2 years after chemotherapyThe 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.
Outcome measures
| Measure |
Patients treated with chemotherapy
n=20 Participants
Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy.
|
Patients not treated with chemotherapy
n=30 Participants
Control patients received only surgery and radiotherapy.
|
|---|---|---|
|
The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire
|
61.7 units on a scale
Standard Deviation 13.2
|
71.1 units on a scale
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: 2 years after chemotherapyThe 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
Outcome measures
| Measure |
Patients treated with chemotherapy
n=20 Participants
Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy.
|
Patients not treated with chemotherapy
n=30 Participants
Control patients received only surgery and radiotherapy.
|
|---|---|---|
|
Neurotoxicity Induced by Adjuvant Chemotherapy by the CIPN20 Questionnaire
|
20.04 units on a scale
Standard Deviation 18.5
|
6.86 units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 2 years after chemotherapyThe 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.
Outcome measures
| Measure |
Patients treated with chemotherapy
n=20 Participants
Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy.
|
Patients not treated with chemotherapy
n=30 Participants
Control patients received only surgery and radiotherapy.
|
|---|---|---|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Physical functioning
|
75.3 points
Standard Deviation 19
|
76.8 points
Standard Deviation 23
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Role functioning
|
77.2 points
Standard Deviation 24.3
|
80.7 points
Standard Deviation 27
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Emotional functioning
|
67.1 points
Standard Deviation 27
|
79.5 points
Standard Deviation 24.6
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Cognitive functioning
|
76.7 points
Standard Deviation 21.9
|
81 points
Standard Deviation 24.3
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Social functioning
|
75.4 points
Standard Deviation 30.6
|
84.6 points
Standard Deviation 24.9
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Fatigue
|
38.8 points
Standard Deviation 23.8
|
22.7 points
Standard Deviation 17.7
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Nausea and vomiting
|
5.8 points
Standard Deviation 16.5
|
8.9 points
Standard Deviation 24.7
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Pain
|
31.6 points
Standard Deviation 33.7
|
25 points
Standard Deviation 25.5
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Dyspnea
|
22.8 points
Standard Deviation 25
|
16 points
Standard Deviation 23.3
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Insomnia
|
36.8 points
Standard Deviation 31.2
|
32.2 points
Standard Deviation 24.4
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Loss of appetite
|
15 points
Standard Deviation 27.5
|
7.1 points
Standard Deviation 16.6
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Financial difficulties
|
18.3 points
Standard Deviation 33.3
|
6 points
Standard Deviation 15.9
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Constipation
|
30 points
Standard Deviation 35.7
|
19.5 points
Standard Deviation 31.5
|
|
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
Diarrhea
|
13.3 points
Standard Deviation 22.7
|
25.9 points
Standard Deviation 35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years after chemotherapyThe 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.
Outcome measures
| Measure |
Patients treated with chemotherapy
n=20 Participants
Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy.
|
Patients not treated with chemotherapy
n=30 Participants
Control patients received only surgery and radiotherapy.
|
|---|---|---|
|
Anxiety by the HADS Questionnaire
|
9.7 units on a scale
Standard Deviation 5.3
|
7.7 units on a scale
Standard Deviation 4.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 years after chemotherapyThe 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.
Outcome measures
| Measure |
Patients treated with chemotherapy
n=20 Participants
Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy.
|
Patients not treated with chemotherapy
n=30 Participants
Control patients received only surgery and radiotherapy.
|
|---|---|---|
|
Depression by the HADS Questionnaire
|
5.8 units on a scale
Standard Deviation 4.2
|
4.9 units on a scale
Standard Deviation 3.5
|
Adverse Events
Patients Treated With Chemotherapy
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Patients Not Treated With Chemotherapy
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients Treated With Chemotherapy
n=20 participants at risk
Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy.
|
Patients Not Treated With Chemotherapy
n=30 participants at risk
Control patients received only surgery and radiotherapy.
|
|---|---|---|
|
GASTROINTESTINAL DISORDERS
HAEMORRHOIDS
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
VASCULAR DISORDERS
LYMPHOEDEMA
|
15.0%
3/20 • Number of events 3 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
0.00%
0/30 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION PROCTITIS
|
5.0%
1/20 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
0.00%
0/30 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
GASTROINTESTINAL DISORDERS
ANAL INFLAMMATION
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
FEBRILE BONE MARROW APLASIA
|
5.0%
1/20 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
0.00%
0/30 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
RENAL AND URINARY DISORDERS
URINARY INCONTINENCE
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
26.7%
8/30 • Number of events 8 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
PSYCHIATRIC DISORDERS
DEPRESSION
|
5.0%
1/20 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
0.00%
0/30 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
|
5.0%
1/20 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
0.00%
0/30 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
10.0%
2/20 • Number of events 2 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
6.7%
2/30 • Number of events 2 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
|
5.0%
1/20 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
0.00%
0/30 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
GASTROINTESTINAL DISORDERS
PROCTITIS
|
5.0%
1/20 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
PELVIC PAIN
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
INTERMENSTRUAL BLEEDING
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
INFECTIONS AND INFESTATIONS
VAGINAL INFECTION
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
DYSPAREUNIA
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
6.7%
2/30 • Number of events 2 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
RENAL AND URINARY DISORDERS
RENAL FAILURE
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
|
15.0%
3/20 • Number of events 3 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
10.0%
2/20 • Number of events 2 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
0.00%
0/30 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
|
5.0%
1/20 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
0.00%
0/30 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
NERVOUS SYSTEM DISORDERS
NEUROPATHY PERIPHERAL
|
35.0%
7/20 • Number of events 7 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
0.00%
0/30 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
45.0%
9/20 • Number of events 9 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
6.7%
2/30 • Number of events 2 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
RENAL AND URINARY DISORDERS
POLLAKIURIA
|
5.0%
1/20 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
6.7%
2/30 • Number of events 2 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
45.0%
9/20 • Number of events 9 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
43.3%
13/30 • Number of events 13 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
RADIATION SKIN INJURY
|
0.00%
0/20 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
3.3%
1/30 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
5.0%
1/20 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
6.7%
2/30 • Number of events 2 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSION
|
5.0%
1/20 • Number of events 1 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
0.00%
0/30 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
|
INFECTIONS AND INFESTATIONS
CYSTITIS
|
20.0%
4/20 • Number of events 4 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
26.7%
8/30 • Number of events 8 • 2 years, assessed retrospectively. Patients were included 2 years after their treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place