Prehabilitation in Gynaecological Cancer Patients

Ovarian Cancer Clinical Trial

— PHOCUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04789694
• Other study ID #: PHOCUS_38/20
• Status: Recruiting
• Phase: Phase 3
• Start date: January 25, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: Charles University, Czech Republic
• Contact: Jana Stribrna
• Phone: +420 224 967 432
• Email: jana.stribrna[@]vfn.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

1. Second malignant tumour (under the treatment)

2. Patient is not suitable for any surgery delay

3. Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Endometrial Cancer
• Endometrial Neoplasms
• Frailty
• Ovarian Cancer
• Ovarian Cancer Stage III
• Ovarian Cancer Stage IV
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Czechia	Gynecologic Oncology Center in Prague	Prague

Sponsors (5)

Lead Sponsor	Collaborator
Charles University, Czech Republic	The Faculty Hospital Na Bulovce, University Hospital Olomouc, University Hospital Ostrava, University Hospital Pilsen

Country where clinical trial is conducted

Czechia, 

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity changes	Six-minute walking test (6MWT)	9-12weeks
Secondary	Postoperative morbidity	Intraoperative and early postoperative complications until the 30th postoperative day will be classified according to the Clavien-Dindo and the Comprehensive Complication Index. Adverse events occurring after 30th postoperative day will be assessed according to NCI Common Terminology Criteria for Adverse Events Version 5.0	9-12weeks
Secondary	Length of postoperative hospital stay (days)		9-12weeks
Secondary	Adherence to training program	Daily step count and number of resistance exercises per week.	9-12weeks
Secondary	Effects of nutritional support program on body composition (weight of fat and lean body mass in kg)		9-12weeks
Secondary	Effects of nutritional support program on resting energy expenditure (measured in kcal/kg).		9-12weeks
Secondary	Effects of nutritional support program on Fatty acids composition of plasmatic and erythrocytes phospholipids (measured in mol%).		9-12weeks
Secondary	Health-related quality of life	The analysis of the QoL of both study ARMs will be made based on EORTC validated questionnaires: QLQ-C30 and OV28 (for ovarian cancer patients)/ EN24 (for endometrial cancer patients.; QLQ-C30 was developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.; The EORTC QLQ-OV28/ EN24 is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 25 items specifically related to ovarian/ endometrial cancer.	9-12weeks
Secondary	Psychological health: DEPRESSION	The Beck Depression Inventory: a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.	9-12weeks
Secondary	Psychological health: ANXIETY	The State-Trait Anxiety Inventory: a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety.	9-12weeks
Secondary	Psychological health: NONSPECIFIC PERCEIVED STRESS	Perceived stress scale: psychological instrument for measuring nonspecific perceived stress (stressfulness of situations, the effectiveness of stress-reducing interventions, and the extent to which there are associations between psychological stress and psychiatric and physical disorders).	9-12weeks
Secondary	Psychological health: SPECIFIC PERCEIVED STRESS	Stress profile: questionnaire assessing the severity of stress in nine areas of life: social habits, social relationships, life events, sexual problems, sleep, psychiatric symptoms, old age, menstrual stresses, and 'stress and the heart'.	9-12weeks