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Gynecologic CancerPhase 3PROPERNCT04596800

Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial

A Phase 3 study testing Prehabilitation Program + Enhanced Recovery After Surgery and Enhanced Recovery After Surgery in people with Gynecologic Cancer and Enhanced Recovery After Surgery, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery. Read more about this study

Who is it for?
Ages 18 to 80 years, women onlyHealthy volunteers can take part
What is being tested?
Prehabilitation Program + Enhanced Recovery After Surgery and Enhanced Recovery After Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
1 siteBrazil
Study dates
5 Nov 2020to Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

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 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients who sign the Informed Consent Form, indicating that they understand the study procedures and their purpose;
  • Women aged between 18 and 80 years old;
  • Gynecological surgery performed by laparotomy;
  • Patients with Eastern Cooperative Oncology Group Performance Status of at least 2 (ECOG ≤2);
  • Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks

Who cannot join

  • Patients under 18 or older than 80 years old;
  • ECOG ≥3;
  • Significant comorbidities, such as: neurological or musculoskeletal disorder, heart disease and / or respiratory failure that prohibit physical exercise;
  • Limitation of ambulation preventing the patient to perform physical exercises;
  • Cognitive deterioration or patients with psychiatric disorder that prevents adherence to the program;
  • Emergency or urgency surgeries;
Show all 11Show fewer
  • Surgeries by minimally invasive approach (laparoscopy or robotics);
  • Vulvectomy or soft tissue surgery without abdominal approach;
  • Minor gynaecological surgeries such as conizations;
  • Surgeries performed together with other specialties, in which the gynecology team is not primarily responsible for postoperative care;
  • If surgery is performed 21 days after the last day of the prehabilitation program, for any reason

Trial locations and contacts

1 site in 1 country.

Andre Lopes, MD contact

+551134744242

andrelopes.cirurgia@gmail.com

Alayne Yamada, PhD contact

+551134744242

alayne.pesquisa@ibcc-mooca.org.br

Brazil1 site, 1 recruiting

  • Instituto Brasileiro de Controle do Cancer - IBCC

    São Paulo

    Alayne Yamada, PhD, +551134744242, alayne.pesquisa@ibcc-mooca.org.br

    Andre Lopes, MD

    Recruiting

Other trials in Brazil

About this study

Official title: Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial

Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.

Read the detailed description

Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to multidisciplinary team and blind to surgeons and anaesthesiologists. The aim is test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.

The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.

Being tested
Prehabilitation Program + Enhanced Recovery After Surgery, Enhanced Recovery After Surgery
Keywords
Prehabilitation, Gynecologic Cancer, ERAS - Enhanced Recovery After Surgery, Gynecologic Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prehabilitation Program + Enhanced Recovery After SurgeryOther

    Also called Prehabilitation + ERAS

    Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol

  • Enhanced Recovery After SurgeryOther

    Also called ERAS protocol

    ERAS

Study groups in NCT04596800
Study groupRoleWhat they receive
Prehabilitation + Enhanced Recovery After SurgeryExperimentalPatients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.
Receives: Other: Prehabilitation Program + Enhanced Recovery After Surgery
Enhanced Recovery After SurgeryActive comparatorPatients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.
Receives: Other: Enhanced Recovery After Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative recovery time

    Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs

    Measured: Up to 30 postoperative days

Secondary outcomes (11)

  1. Complications and Adverse Effects

    Complications and Adverse Effects according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 2017

    Measured: Up to 30 postoperative days

  2. Readmissions

    Readmission to the Hospital Facilities

    Measured: Up to 30 postoperative days

  3. Intensive Care Unit admission rates

    Postoperative Intensive Care Unit admission and stay

    Measured: Up to 30 postoperative days

  4. Health-related Quality of Life

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Measured: At Baseline, the week before surgery, then at postoperative days 7, 30 and 60

  5. Compliance to the ERAS® program guideline

    Compliance to ERAS® protocol and implementation of the program

    Measured: Up to 30 postoperative days

  6. Changes in anxiety and depression from baseline

    Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.

    Measured: At Baseline, the week before surgery, then at postoperative days 7, 30 and 60

  7. Changes in functional capacity from baseline

    Patients will perform a 6-Minute Walk Test

    Measured: At Baseline, the week before surgery, then at postoperative days 30 and 60

  8. Change in muscle strength

    Muscle strength is measured by using an dynamometer

    Measured: At Baseline, the week before surgery, then at postoperative days 30 and 60

  9. Change in body mass

    Body mass is measured by using a bioelectrical impedance analysis

    Measured: At Baseline, the week before surgery, then at postoperative days 30 and 60

  10. Hospital stay

    Days from surgical procedure to hospital discharge

    Measured: Up to 30 days

  11. Use of opioids in acute postoperative pain

    Use and dosage of opioids in the postoperative period

    Measured: Up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start5 Nov 2020
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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
Single blind
Who is masked
Investigator
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04596800
Sponsor's protocol ID
36924620.7.0000.0072
Acronym
PROPER
Status last verified
Oct 2023
First submitted
18 Oct 2020
Last updated
31 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication of the results

Publications

  • Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.

    PubMed 25076007

  • Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.

    PubMed 24439570

  • Barberan-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 28489682

  • Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.

    PubMed 26603969

  • Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.

    PubMed 26757238

  • Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.

    PubMed 30877144

  • Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.

    PubMed 14555665

  • Iyer R, Gentry-Maharaj A, Nordin A, Burnell M, Liston R, Manchanda R, Das N, Desai R, Gornall R, Beardmore-Gray A, Nevin J, Hillaby K, Leeson S, Linder A, Lopes A, Meechan D, Mould T, Varkey S, Olaitan A, Rufford B, Ryan A, Shanbhag S, Thackeray A, Wood N, Reynolds K, Menon U. Predictors of complications in gynaecological oncological surgery: a prospective multicentre study (UKGOSOC-UK gynaecological oncology surgical outcomes and complications). Br J Cancer. 2015 Feb 3;112(3):475-84. doi: 10.1038/bjc.2014.630. Epub 2014 Dec 23.

    PubMed 25535730

  • Miralpeix E, Mancebo G, Gayete S, Corcoy M, Sole-Sedeno JM. Role and impact of multimodal prehabilitation for gynecologic oncology patients in an Enhanced Recovery After Surgery (ERAS) program. Int J Gynecol Cancer. 2019 Oct;29(8):1235-1243. doi: 10.1136/ijgc-2019-000597. Epub 2019 Aug 30.

    PubMed 31473663

  • Lopes A, Yamada AMTD, Cardenas TC, Carvalho JN, Oliveira EA, Silva MERD, Andrade JFM, de Souza Neto E, Barros LADR, Costa RLR. PROPER-PRehabilitatiOn Plus Enhanced Recovery after surgery versus enhanced recovery after surgery in gynecologic oncology: a randomized clinical trial. Int J Gynecol Cancer. 2022 Feb;32(2):195-197. doi: 10.1136/ijgc-2021-003170. Epub 2021 Nov 8.

    PubMed 34750197

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prehabilitation Program + Enhanced Recovery After Surgery and Enhanced Recovery After Surgery in people with Gynecologic Cancer and Enhanced Recovery After Surgery, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.

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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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 Brazil. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andre Lopes, MD (+551134744242, andrelopes.cirurgia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative recovery time (time frame: Up to 30 postoperative days). 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 NCT04596800, which also lists 10 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 31 Oct 2023.

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