RecruitingPhase 3NCT04789694

Prehabilitation in Gynaecological Cancer Patients

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


Sponsor

Charles University, Czech Republic

Enrollment

64 participants

Start Date

Jan 25, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a "prehabilitation" program — exercise, nutrition, and psychological support before surgery or chemotherapy — can improve outcomes for women with gynaecological cancer. The idea is that getting fitter and stronger before treatment can help patients tolerate it better and recover faster. **You may be eligible if...** - You have advanced ovarian cancer (stage III or IV) and are starting chemotherapy before surgery, OR - You have stage I or II endometrial cancer and are considered frail based on a validated health assessment - You are considered a suitable candidate for surgery after treatment **You may NOT be eligible if...** - Your cancer is at a different stage or type not covered by the trial - You are not a candidate for standard-of-care chemotherapy or surgery - You do not meet the frailty or staging criteria required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPhysiological intervention

* Rehabilitation specialist consultation (3x) * Individualized home-based exercise plan * Functional capacity measuring

BEHAVIORALPsychological intervention

* Clinical psychologist consultation (3x) * Anxiety and depression scoring * Psychological support

DIETARY_SUPPLEMENTNutritional intervention

* Nutritional specialist consultation (3x) * Malnutrition scoring * Dietary supplementation


Locations(1)

Gynecologic Oncology Center in Prague

Prague, Czechia

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NCT04789694


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