NCT04789694

Prehabilitation in Gynaecological Cancer Patients

Prehabilitation in Patients With Gynaecological Cancer Planned for Postponed Surgical Management: A Prospective Randomised Trial.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer
• Ovarian Cancer Stage III
• Ovarian Cancer Stage IV
• Endometrial Cancer
• Frailty

Interventions

Type	Name	Description
OTHER	Physiological intervention	* Rehabilitation specialist consultation (3x) * Individualized home-based exercise plan * Functional capacity measuring
BEHAVIORAL	Psychological intervention	* Clinical psychologist consultation (3x) * Anxiety and depression scoring * Psychological support
DIETARY_SUPPLEMENT	Nutritional intervention	* Nutritional specialist consultation (3x) * Malnutrition scoring * Dietary supplementation

Timeline

• Start date: 2021-01-25
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2021-03-09
• Last updated: 2026-03-19

Locations

1 site across 1 country: Czechia