Ovarian CancerPhase 3PHOCUSNCT04789694
Prehabilitation in Gynaecological Cancer Patients
A Phase 3 study testing Physiological intervention, Psychological intervention and Nutritional intervention in people with Ovarian Cancer and Ovarian Cancer Stage III, run by Charles University, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV
- What is being tested?
- Physiological intervention, Psychological intervention and Nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Mar 2021to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Two groups of patients will be eligible for the trial:
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stefan Lednicky, MD. contact
Czechia1 site, 1 recruiting
- Recruiting
Gynecologic Oncology Center in Prague
Prague, 12000
David Cibula, M.D., +420603547055, dc@davidcibula.cz
Jana Stribrna, +420224967432, jana.stribrna@vfn.cz
About this study
Official title: Prehabilitation in Patients With Gynaecological Cancer Planned for Postponed Surgical Management: A Prospective Randomised Trial.
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.
Read the 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
- Being tested
- Physiological intervention, Psychological intervention, Nutritional intervention
- Keywords
- Prehabilitation, Epitelial ovarian cancer, Functional capacity, Quality of life, Multimodal prehabilitation, Frailty, Endometrial cancer
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological interventionOther
- Rehabilitation specialist consultation (3x)
- Individualized home-based exercise plan
- Functional capacity measuring
Psychological interventionBehavioural
- Clinical psychologist consultation (3x)
- Anxiety and depression scoring
- Psychological support
Nutritional interventionDietary supplement
- Nutritional specialist consultation (3x)
- Malnutrition scoring
- Dietary supplementation
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Patients will be provided with a basic information and standard of care support. |
| B | Experimental | 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. Receives: Other: Physiological intervention; Behavioral: Psychological intervention; Dietary Supplement: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity changes
Six-minute walking test (6MWT)
Measured: 9-12weeks
Secondary outcomes (11)
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
Measured: 9-12weeks
Length of postoperative hospital stay (days)
Measured: 9-12weeks
Adherence to training program
Daily step count and number of resistance exercises per week.
Measured: 9-12weeks
Effects of nutritional support program on body composition (weight of fat and lean body mass in kg)
Measured: 9-12weeks
Effects of nutritional support program on resting energy expenditure (measured in kcal/kg).
Measured: 9-12weeks
Effects of nutritional support program on Fatty acids composition of plasmatic and erythrocytes phospholipids (measured in mol%).
Measured: 9-12weeks
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.
Measured: 9-12weeks
Psychological health: DEPRESSION
The Beck Depression Inventory: a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Measured: 9-12weeks
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.
Measured: 9-12weeks
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).
Measured: 9-12weeks
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'.
Measured: 9-12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start25 Mar 2021
- Primary completion30 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Ostrava, University Hospital Olomouc, University Hospital Pilsen, The Faculty Hospital Na Bulovce
- Responsible party
- Principal investigator, David Cibula, Charles University, Czech Republic
- Investigators
- David Cibula, prof., Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789694
- Sponsor's protocol ID
- PHOCUS_38/20
- Acronym
- PHOCUS
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2021
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cook PC, Leit ME. Issues in the pediatric athlete. Orthop Clin North Am. 1995 Jul;26(3):453-64.
PubMed 7609960Althoff FC, Neb H, Herrmann E, Trentino KM, Vernich L, Fullenbach C, Freedman J, Waters JH, Farmer S, Leahy MF, Zacharowski K, Meybohm P, Choorapoikayil S. Multimodal Patient Blood Management Program Based on a Three-pillar Strategy: A Systematic Review and Meta-analysis. Ann Surg. 2019 May;269(5):794-804. doi: 10.1097/SLA.0000000000003095.
PubMed 30418206Peteroy ET, Pirrello PE, Adams N. The relationship between two Wiggins Content Scales and length of hospitalization. J Clin Psychol. 1982 Apr;38(2):344-6. doi: 10.1002/1097-4679(198204)38:23.0.co;2-z.
PubMed 7068871Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
PubMed 28489682Beck A, Vind Thaysen H, Hasselholt Soegaard C, Blaakaer J, Seibaek L. Prehabilitation in cancer care: patients' ability to prepare for major abdominal surgery. Scand J Caring Sci. 2021 Mar;35(1):143-155. doi: 10.1111/scs.12828. Epub 2020 Feb 11.
PubMed 32043644Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12.
PubMed 21663994Biglia N, Zanfagnin V, Daniele A, Robba E, Bounous VE. Lower Body Lymphedema in Patients with Gynecologic Cancer. Anticancer Res. 2017 Aug;37(8):4005-4015. doi: 10.21873/anticanres.11785.
PubMed 28739682Blackwell JEM, Doleman B, Boereboom CL, Morton A, Williams S, Atherton P, Smith K, Williams JP, Phillips BE, Lund JN. High-intensity interval training produces a significant improvement in fitness in less than 31 days before surgery for urological cancer: a randomised control trial. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):696-704. doi: 10.1038/s41391-020-0219-1. Epub 2020 Mar 10.
PubMed 32157250Burden S, Todd C, Hill J, Lal S. Pre-operative nutrition support in patients undergoing gastrointestinal surgery. Cochrane Database Syst Rev. 2012 Nov 14;11:CD008879. doi: 10.1002/14651858.CD008879.pub2.
PubMed 23152265Burke SM, Brunet J, Sabiston CM, Jack S, Grocott MP, West MA. Patients' perceptions of quality of life during active treatment for locally advanced rectal cancer: the importance of preoperative exercise. Support Care Cancer. 2013 Dec;21(12):3345-53. doi: 10.1007/s00520-013-1908-2. Epub 2013 Aug 3.
PubMed 23912669Carli F, Brown R, Kennepohl S. Prehabilitation to enhance postoperative recovery for an octogenarian following robotic-assisted hysterectomy with endometrial cancer. Can J Anaesth. 2012 Aug;59(8):779-84. doi: 10.1007/s12630-012-9734-4. Epub 2012 May 26.
PubMed 22638674Cianci S, Tarascio M, Rosati A, Caruso S, Uccella S, Cosentino F, Scaletta G, Gueli Alletti S, Scambia G. Sexual function and quality of life of patients affected by ovarian cancer. Minerva Med. 2019 Aug;110(4):320-329. doi: 10.23736/S0026-4806.19.06080-4. Epub 2019 May 6.
PubMed 31081305Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
PubMed 23395245Cortes-Guiral D, Mohamed F, Glehen O, Passot G. Prehabilitation of patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal malignancy. Eur J Surg Oncol. 2021 Jan;47(1):60-64. doi: 10.1016/j.ejso.2020.01.032. Epub 2020 Jan 30.
PubMed 32063398Daroszewski C, Stasiewicz M, Jazwinska-Tarnawska E, Rachwalik A, Mura E, Luboch-Kowal J, Drys A, Bogucki ZA, Brzecka A. Quality of Life in Patients with Advanced Non-Small-Cell Lung Cancer Receiving Palliative Chemotherapy. Adv Exp Med Biol. 2019;1160:11-18. doi: 10.1007/5584_2019_346.
PubMed 30825114
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation in Patients With Gynaecological Cancer Planned for Postponed Surgical Management: A Prospective Randomised Trial.
- ClinicalTrials.gov ID
- NCT04789694
- Acronym / sponsor ID
- PHOCUS / PHOCUS_38/20
- Conditions
- Ovarian Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Endometrial Cancer, Frailty
- Keywords
- Prehabilitation, Epitelial ovarian cancer, Functional capacity, Quality of life, Multimodal prehabilitation, Frailty, Endometrial cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- University Hospital Ostrava, University Hospital Olomouc, University Hospital Pilsen, The Faculty Hospital Na Bulovce
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Patients will be provided with a basic information and standard of care support. |
| B | Experimental | Other: Physiological intervention, Behavioral: Psychological intervention, Dietary Supplement: Nutritional interventionActive 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological intervention* Rehabilitation specialist consultation (3x) * Individualized home-based exercise plan * Functional capacity measuring | Other | B |
| Psychological intervention* Clinical psychologist consultation (3x) * Anxiety and depression scoring * Psychological support | Behavioural | B |
| Nutritional intervention* Nutritional specialist consultation (3x) * Malnutrition scoring * Dietary supplementation | Dietary supplement | B |
Primary outcome
Functional capacity changes
Time frame: 9-12weeks
Six-minute walking test (6MWT)
11 secondary outcomes
Postoperative morbidity
Time frame: 9-12weeks
Length of postoperative hospital stay (days)
Time frame: 9-12weeks
Adherence to training program
Time frame: 9-12weeks
Effects of nutritional support program on body composition (weight of fat and lean body mass in kg)
Time frame: 9-12weeks
Effects of nutritional support program on resting energy expenditure (measured in kcal/kg).
Time frame: 9-12weeks
Effects of nutritional support program on Fatty acids composition of plasmatic and erythrocytes phospholipids (measured in mol%).
Time frame: 9-12weeks
Health-related quality of life
Time frame: 9-12weeks
Psychological health: DEPRESSION
Time frame: 9-12weeks
Psychological health: ANXIETY
Time frame: 9-12weeks
Psychological health: NONSPECIFIC PERCEIVED STRESS
Time frame: 9-12weeks
Psychological health: SPECIFIC PERCEIVED STRESS
Time frame: 9-12weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 7609960Cook PC, Leit ME. Issues in the pediatric athlete. Orthop Clin North Am. 1995 Jul;26(3):453-64.
- Background: PubMed 30418206Althoff FC, Neb H, Herrmann E, Trentino KM, Vernich L, Fullenbach C, Freedman J, Waters JH, Farmer S, Leahy MF, Zacharowski K, Meybohm P, Choorapoikayil S. Multimodal Patient Blood Management Program Based on a Three-pillar Strategy: A Systematic Review and Meta-analysis. Ann Surg. 2019 May;269(5):794-804. doi: 10.1097/SLA.0000000000003095.
- Background: PubMed 7068871Peteroy ET, Pirrello PE, Adams N. The relationship between two Wiggins Content Scales and length of hospitalization. J Clin Psychol. 1982 Apr;38(2):344-6. doi: 10.1002/1097-4679(198204)38:23.0.co;2-z.
- Background: PubMed 28489682Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
- Background: PubMed 32043644Beck A, Vind Thaysen H, Hasselholt Soegaard C, Blaakaer J, Seibaek L. Prehabilitation in cancer care: patients' ability to prepare for major abdominal surgery. Scand J Caring Sci. 2021 Mar;35(1):143-155. doi: 10.1111/scs.12828. Epub 2020 Feb 11.
- Background: PubMed 21663994Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12.
- Background: PubMed 28739682Biglia N, Zanfagnin V, Daniele A, Robba E, Bounous VE. Lower Body Lymphedema in Patients with Gynecologic Cancer. Anticancer Res. 2017 Aug;37(8):4005-4015. doi: 10.21873/anticanres.11785.
- Background: PubMed 32157250Blackwell JEM, Doleman B, Boereboom CL, Morton A, Williams S, Atherton P, Smith K, Williams JP, Phillips BE, Lund JN. High-intensity interval training produces a significant improvement in fitness in less than 31 days before surgery for urological cancer: a randomised control trial. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):696-704. doi: 10.1038/s41391-020-0219-1. Epub 2020 Mar 10.
- Background: PubMed 23152265Burden S, Todd C, Hill J, Lal S. Pre-operative nutrition support in patients undergoing gastrointestinal surgery. Cochrane Database Syst Rev. 2012 Nov 14;11:CD008879. doi: 10.1002/14651858.CD008879.pub2.
- Background: PubMed 23912669Burke SM, Brunet J, Sabiston CM, Jack S, Grocott MP, West MA. Patients' perceptions of quality of life during active treatment for locally advanced rectal cancer: the importance of preoperative exercise. Support Care Cancer. 2013 Dec;21(12):3345-53. doi: 10.1007/s00520-013-1908-2. Epub 2013 Aug 3.
- Background: PubMed 22638674Carli F, Brown R, Kennepohl S. Prehabilitation to enhance postoperative recovery for an octogenarian following robotic-assisted hysterectomy with endometrial cancer. Can J Anaesth. 2012 Aug;59(8):779-84. doi: 10.1007/s12630-012-9734-4. Epub 2012 May 26.
- Background: PubMed 31081305Cianci S, Tarascio M, Rosati A, Caruso S, Uccella S, Cosentino F, Scaletta G, Gueli Alletti S, Scambia G. Sexual function and quality of life of patients affected by ovarian cancer. Minerva Med. 2019 Aug;110(4):320-329. doi: 10.23736/S0026-4806.19.06080-4. Epub 2019 May 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Lednicky, MD. contact
David Cibula, prof. principal investigator
Charles University, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Physiological intervention, Psychological intervention and Nutritional intervention in people with Ovarian Cancer and Ovarian Cancer Stage III, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jana Stribrna (+420 224 967 432, jana.stribrna@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity changes (time frame: 9-12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04789694, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.