Ovarian Cancer
Conditions
Keywords
ovarian cancer, prehabilitation, interval debulking surgery, neoadjuvant chemotherapy
Brief summary
Prehabilitation includes care for patients preparing for surgery. This is a modern approach aimed at increasing the patient's functional capacity before surgery and improving postoperative results. Prehabilitation includes preoperative physical activity, nutritional intervention, psychological support, cessation of stimulants and optimization of laboratory test results. Many studies have shown a positive effect of prehabilitation on postoperative results, mainly reducing the number of postoperative complications and shortening the hospitalization time. The assumed time of prehabilitation is 2-6 weeks, but in the case of oncology patients, the procedure should not be delayed only for the sake of prehabilitation. Our study includes oncology patients with ovarian cancer who are referred for neoadjuvant chemotherapy before interval cytoreductive surgery. The assumption of the study is an intensive course of prehabilitation during neoadjuvant treatment, which should provide significantly better postoperative results.
Interventions
PROCEDUREPrehabilitation. An intensive prehabilitation for NACT patients
Patients referred to NACT (neoadjuvant chemotheraphy) for advanced ovarian cancer will undergo an intensive course of prehabilitation including physical exercise, a high-protein diet, protein and vitamin supplementation, optimization of laboratory test results, and psychological support will be provided.
Sponsors
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The intervention group consists of patients undergoing prehabilitation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with confirmed ovarian cancer * No possibility of performing primary debulking surgery (Fagotti score \> 8 points). Referral patient for neoadjuvant chemotherapy * Consent to participate in the study * Age over 18 years
Exclusion criteria
* Performing primary debulking surgery * Lack of consent to participate in the study * Aletti score \< 4 points in interval debulking surgery * Severe neurological/psychiatric disorders that make contact with the patient difficult
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | from surgery to hospital discharge (assessed up to 14 days) | The analysis will include the length of hospitalization after surgery. |
| Frequency of postoperative complications | from surgery for the next 30 days | Analysis of the incidence of complications, including assessment according to the Clavien-Dindo classification. Analysis of complications will include the incidence of intensive care units hospitalization, frequency of reoperation, dehiscence of intestinal anastomosis, wound dehiscence with eventeration, need for blood transfusion and readmission within 30 days |
| Time to start adjuvant chemotherapy | from discharge from hospital for the next 2 months | Comparison of time from hospital discharge to start of adjuvant chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From the time of the operation for the next 3 and 5 years | Comparison of overall survival in both groups at 3 and 5 years of follow-up |
| Progression-free survival | From the time of the operation for the next 3 and 5 years | Comparison of progression-free survival in both groups at 3 and 5 years of follow-up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment | From study enrollment to surgery (up to 4 months) | Measuring changes in quality of life during the prehabilitation program. The assessment of quality of life will be performed using the standardized EORTC Quality of Life QLQ-C30 questionnaire. The EORTC QLQ-C30 assesses quality of life in five functional domains (physical, role, cognitive, emotional, and social), three symptom domains (fatigue, pain, nausea and vomiting), a global health status domain (GHS/QoL), and five single-item domains (dyspnoea, insomnia, loss of appetite, constipation and diarrhea, and financial problems due to illness) The higher the score in the functional domains and in the global health status domain, the better the patient's quality of life, while the higher the score in the symptom domain, the worse the quality of life due to the severity of disease-related symptoms. |
| Depression and anxiety assessment | from study enrollment to surgery (up to 4 months) | Measuring changes in depression and anxiety during the prehabilitation program. The assessment of depression and anxiety will be performed using the HADS questionnaire. The HADS is a self-report questionnaire, and it consists of 2 subscales designed to identify and quantify anxiety and depression in patients, especially in oncological patients whereas a score of 8 points indicates mild anxiety or depression and the higher the score, the greater the severity of anxiety and depressive disorders. |
Countries
Poland
Outcome results
None listed