Prehabilitation in Patients With Gynaecological Cancer Planned for Postponed Surgical Management: A Prospective Randomised Trial.
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Functional capacity changes
Study Overview
Brief Summary
Prehabilitation refers to interventions aiming to improve patients' resilience and functional capacity before a known stressful event, e.g., scheduled surgery. These interventions usually consist of physical activity and psychological and nutritional support. There is substantial evidence of the positive effect of multimodal prehabilitation among patients treated surgically for non-gynaecological cancers; however, no prospective data are available in gynaecological cancer patients.
PHOCUS trial is a prospective randomised trial aiming to evaluate the role of multimodal prehabilitation in patients with gynaecological cancer. Sixty-four patients will be randomised in single institution within 36 months with a 1:1 ratio into ARM A: control arm which will be provided with a basic information and standard of care support; ARM B: active arm undergoing multimodal prehabilitation composed of physical activity and psychological and nutritional support. All patients will be assessed at standard intervals (three times during the trial) by a spectrum of non-invasive tests, evaluating physical functional capacity, postoperative morbidity, nutritional status, level of stress and anxiety, and quality of life.
Detailed Description
The objective of the trial is to evaluate the impact of intensive multimodal prehabilitation protocol on pre-operative functional capacity, postoperative morbidity, and quality of life in patients undergoing surgical treatment for gynaecological cancer.
Two groups of patients scheduled for postponed surgical treatment will be eligible for the trial: i) advanced ovarian cancer patients referred for neoadjuvant chemotherapy and interval debulking surgery; ii) stage I-II endometrial cancer patients classifying as frail (according to the validated modified Frailty Index), who will be treated by hormonal therapy for three months, followed by surgical treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Two groups of patients will be eligible for the trial:
- •i) Epithelial ovarian cancer patients referred for NACT: a) FIGO stage III or IV disease; b) Patient is not a candidate for primary debulking surgery; c) Patient is a suitable candidate for standard of care combined chemotherapy; d) Patient is a candidate for interval.debulking surgery
- •ii) Stage I or II endometrial cancer patients classifying as frail according to the validated modified Frailty Index: a) FIGO stage I or II; b) Patient is classified as frail; c) Patient is suitable candidate for hormonal therapy.
Exclusion Criteria
- •Second malignant tumour (under the treatment)
- •Patient is not suitable for any surgery delay
- •Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk
Arms & Interventions
A
Patients will be provided with a basic information and standard of care support.
B
Active prehabilitation will be provided, composed of i) three physical activity-related interventions provided by a physical and rehabilitation medicine (PRM) specialist; iii) three 30 min consultations regarding nutritional status with physician or nutrition specialist; ii) three sessions with psychologist.
Intervention: Physiological intervention (Other)
B
Active prehabilitation will be provided, composed of i) three physical activity-related interventions provided by a physical and rehabilitation medicine (PRM) specialist; iii) three 30 min consultations regarding nutritional status with physician or nutrition specialist; ii) three sessions with psychologist.
Intervention: Psychological intervention (Behavioral)
B
Active prehabilitation will be provided, composed of i) three physical activity-related interventions provided by a physical and rehabilitation medicine (PRM) specialist; iii) three 30 min consultations regarding nutritional status with physician or nutrition specialist; ii) three sessions with psychologist.
Intervention: Nutritional intervention (Dietary Supplement)
Outcomes
Primary Outcomes
Functional capacity changes
Time Frame: 9-12weeks
Six-minute walking test (6MWT)
Secondary Outcomes
- Length of postoperative hospital stay (days)(9-12weeks)
- Adherence to training program(9-12weeks)
- Effects of nutritional support program on body composition (weight of fat and lean body mass in kg)(9-12weeks)
- Psychological health: SPECIFIC PERCEIVED STRESS(9-12weeks)
- Effects of nutritional support program on resting energy expenditure (measured in kcal/kg).(9-12weeks)
- Psychological health: ANXIETY(9-12weeks)
- Psychological health: NONSPECIFIC PERCEIVED STRESS(9-12weeks)
- Postoperative morbidity(9-12weeks)
- Effects of nutritional support program on Fatty acids composition of plasmatic and erythrocytes phospholipids (measured in mol%).(9-12weeks)
- Health-related quality of life(9-12weeks)
- Psychological health: DEPRESSION(9-12weeks)
Investigators
David Cibula
professor
Charles University, Czech Republic