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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03466788

Acronym

EndoQOL

Enrollment

Registered

2018-03-15

Start date

2018-03-29

Completion date

2020-03-28

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Effect, Endometrial Cancer, Quality of Life

Brief summary

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

Detailed description

Endometrial cancer is the fourth most common cancer in women in developed countries. The diagnosis is often made at a localized stage (67% of cases), making it a relatively good cancer prognosis with a 5-year all-stage survival of 81.7%. Its management at the localized stage is based on surgery and radiotherapy. Adjuvant chemotherapy may be offered in addition to radiotherapy, but its place is still debated. It is classically delivered sequentially before or after radiotherapy, concomitant radiochemotherapy not being a standard. It is generally recommended in case of stage III, and for the earlier stages, its use is based on various prognostic factors (histological type, grade, emboli) and the feasibility of treatment (age, general condition, comorbidities). In fact, patients treated for endometrial cancer are elderly (median age 63 years) and in the majority of cases present comorbidities (diabetes, obesity and hypertension). Chemotherapy can induce side effects that can persist and potentially alter the quality of life of these often fragile patients. Although the impact of surgery and radiotherapy on the quality of life has been well studied, there is insufficient literature data for adjuvant chemotherapy. The investigator propose a case-control study that will evaluate the quality of life and late sequelae of patients treated for locally advanced endometrial cancer with sequential adjuvant chemotherapy before or after radiotherapy at a distance from their management. comparing their results to a group of patients who had been treated with postoperative radiotherapy alone.

Interventions

OTHERSelf questionnaires of quality of life and living conditions

Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Masking description

open label

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

For all patients: * Women over 18 years of age, with histologically confirmed histologic type 1 or type 2 endometrial adenocarcinoma, with FIGO postoperative II or III stage operated between 2011 and 2015, with at least 2 years of follow-up compared to the last course of chemotherapy; * Recommended surgery such as hysterectomy and bilateral salpingo-oophorectomy, non-mandatory surgical nodal staging; * Pelvic radiotherapy +/- lumbar-aortic irradiation, optional brachytherapy; * No recurrence of endometrial cancer at baseline; * Absence of evolutionary neurological antecedent (multiple sclerosis, neurodegenerative pathology ...); * Absence of progressive psychiatric pathology (i.e. psychiatric hospitalization, bipolar disorder, schizophrenia, personality disorders ...); * No opposition to the collection of data; * Patient deemed fit to answer a written questionnaire. For the patient in the chemotherapy group - Chemotherapy after surgery that can be performed before or after radiotherapy

Exclusion criteria

For all patients: * Sarcoma or carcinosarcoma; * Stage FIGO I or IV; * Macroscopic tumor residue after surgery; * Recurrence of endometrial cancer or diagnosis of any other cancerous pathology after diagnosis of endometrial cancer (except non-melanotic skin tumors with complete excision), within 5 years; * drug use; * Abuse of alcohol. For the patient in the chemotherapy group * Chemotherapy before surgery; * Chemotherapy concomitant with radiotherapy For the patient in the group without chemotherapy \- Chemotherapy whether before or after surgery

Design outcomes

Primary

Measure	Time frame	Description
The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire	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.

Secondary

Measure	Time frame	Description
Neurotoxicity Induced by Adjuvant Chemotherapy by the CIPN20 Questionnaire	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
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire	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.

Other

Measure	Time frame	Description
Anxiety by the HADS Questionnaire	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.
Depression by the HADS Questionnaire	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.

Countries

France

Participant flow

Participants by arm

Arm	Count
Patients Treated With Chemotherapy Case patients had sequential carboplatin AUC5 -paclitaxel 175 mg/m2 J1=J21, excluding concomitant chemotherapy with radiotherapy.	20
Patients Not Treated With Chemotherapy Control patients received only surgery and radiotherapy.	30
Total	50

Baseline characteristics

Characteristic	Patients Not Treated With Chemotherapy	Patients Treated With Chemotherapy	Total
Age, Continuous	69.6 years STANDARD_DEVIATION 10	65.3 years STANDARD_DEVIATION 9	67.9 years STANDARD_DEVIATION 9.6
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	30 Participants	20 Participants	50 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants
WHO performance status 0	24 Participants	16 Participants	40 Participants
WHO performance status 1	2 Participants	2 Participants	4 Participants
WHO performance status 2	0 Participants	1 Participants	1 Participants
WHO performance status Unknown	4 Participants	1 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 30
other Total, other adverse events	16 / 20	25 / 30
serious Total, serious adverse events	0 / 20	0 / 30

Outcome results

Primary

The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire

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.