Metastasis LungNCT05310539
Early Recovery After "Wedge Resection" Surgery to Remove Lung Mestastasis Secondary to Bone Cancer.
An observational study of Metastasis Lung and Bone Neoplasm, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
After "wedge resection" surgery, the physiotherapy programs proposed in the literature are heterogeneous and there are few data on the outcomes of such treatments in an oncological population for bone cancer. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Metastasis Lung, Bone Neoplasm
- What is being tested?
- assessment of the early recovery after wedge resection surgery
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2022to 8 Jan 2024
- Phase
- Observational
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: all patients admitted to the ward with a diagnosis of pulmonary metastases from bone cancer will be enrolled consecutively for the study.
Who may be able to join
- over 12 years of age
- ablative thoracic surgery for metastases localized to the lung and / or chest wall for primary bone cancer
- must be able to perform the "one minute sit-to-stand" test in the preoperative physiotherapy evaluation
Who cannot join
- ablative thoracic surgery for a diagnosis DIFFERENT FROM that of lung metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation Treatment and Early Recovery After "Wedge Resection" for Pulmonary Metastasis Secondary to Bone Cancer: an Observational Study.
After "wedge resection" surgery, the physiotherapy programs proposed in the literature are heterogeneous and there are few data on the outcomes of such treatments in an oncological population for bone cancer.
The aim of the study is to describe the early rehabilitation process after wedge resection surgery secondary to bone tumor pulmonary mestasasis, highlightining the possible functional recovery in the short and medium term after surgery and indentifying the possible prognostic factors.
Read the detailed description
In Italy, the incidence of primary bone tumors is around 0.8-1 case per 100,000 inhabitants, therefore an estimated 500 new cases of primary malignant bone tumors are estimated each year, affecting more frequently in children and young people. The presence of pulmonary metastasis occurs in 30% of the population with bone cancer and is the most common site of metastasis. Where possible, the elective treatment of lung metastases is ablative surgery and the wedge resection technique is also commonly used in the event of repeated metastasis over time. Pulmonary wedge resection surgery does not follow the anatomical limits of the lung but it is customized according to the metastatic area to be removed, thus differentiating itself from lobectomies and other thoracotomy surgical techniques.
The trend of vital capacity (CV) and forced expiratory volume in 1s (FEV1), after wedge resection surgery, significantly decrease at 3 months compared to the preoperative evaluation, while at 12 months the CV returns to values close to the preoperative ones and FEV1 remains significantly lower. Rehabilitation treatment is part of the multidisciplinary approach for this type of patient in order to prevent post-surgical respiratory complications (PPC) and shoulder girdle dysfunctions, in the treatment of pain and in the recovery of respiratory volumes. Several authors, describing the physiotherapy treatment techniques, include breathing exercises (Active Cycle Breathing Techniques), early mobilization exercises for the lower limbs and the use of volume incentives. The physiotherapy treatment programs proposed in the literature are heterogeneous and there are no data on the feasibility of such treatments in an oncological population for bone cancer.
Patients are enrolled consecutively in a ward of an italian hospital specialized in bone tumor surgery.
- Conditions
- Metastasis Lung, Bone Neoplasm
- Being tested
- assessment of the early recovery after wedge resection surgery
- Keywords
- pulmonary rehabilitation, wedge resection, early recovery
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of the early recovery after wedge resection surgeryOther
To assess the early recovery will be used 1 minute sit to stand, Numeric Rating scale to assess pain, incentive spirometer to assess vital capacity, Borg modified scale to assess dyspnea.
What is being measured
The primary outcome is the main question the study is designed to answer.
1 minute sit to stand (Sixth day after surgery)
The test requires the person to stand up from a chair, without the help of the arms, fully extending their knees, and sit down the greatest number of times in the time of one minute.
Measured: Sixth day after surgery
Secondary outcomes (6)
1 minute sit to stand (daily)
The test requires the person to stand up from a chair, without the help of the arms, fully extending their knees, and sit down the greatest number of times in the time of one minute.
Measured: every day after surgery up to 7 day; at 3, 6 and 12 months after surgery.
pain intensity
numeric rating scale (from 0 (no pain) to 10 (worst possible pain))
Measured: every day after surgery up to 7 day, twice a day
vital capacity (ml)
the vital capacity will be assess with incentive spirometer named "respirex"
Measured: every day after surgery up to 7 day, twice a day
heart rate (bpm)
beats per minute; it will be assess with pulse oximeter
Measured: once a day, before and after 1 minute sit to stand test, up to 7 day
peripheral oxygen saturation (SpO2 %)
it will be assess with pulse oximeter
Measured: once a day, before and after 1 minute sit to stand test, up to 7 day
mBorg Score
dyspnea (shortness of breath, sometimes described as "air hunger") it will be assess using Borg Modified Scale, from 0 to 10, when 0 means "none" (better outcome) and 10 means "maximum" (worse outcome).
Measured: once a day, before and after 1 minute sit to stand test, up to 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start8 Jan 2022
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Metastasis LungStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- marco cotti, pt, Principal investigator, IOR - Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310539
- Sponsor's protocol ID
- WEDGE
- Status last verified
- Feb 2025
- First submitted
- 14 Mar 2022
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vijayamurugan N, Bakhshi S. Review of management issues in relapsed osteosarcoma. Expert Rev Anticancer Ther. 2014 Feb;14(2):151-61. doi: 10.1586/14737140.2014.863453. Epub 2013 Nov 26.
PubMed 24308680Mori S, Shibazaki T, Noda Y, Kato D, Nakada T, Asano H, Matsudaira H, Ohtsuka T. Recovery of pulmonary function after lung wedge resection. J Thorac Dis. 2019 Sep;11(9):3738-3745. doi: 10.21037/jtd.2019.09.32.
PubMed 31656646Bohannon RW, Crouch R. 1-Minute Sit-to-Stand Test: SYSTEMATIC REVIEW OF PROCEDURES, PERFORMANCE, AND CLINIMETRIC PROPERTIES. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):2-8. doi: 10.1097/HCR.0000000000000336.
PubMed 30489442Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016.
PubMed 27799759Tremblay Labrecque PF, Harvey J, Nadreau E, Maltais F, Dion G, Saey D. Validation and Cardiorespiratory Response of the 1-Min Sit-to-Stand Test in Interstitial Lung Disease. Med Sci Sports Exerc. 2020 Dec;52(12):2508-2514. doi: 10.1249/MSS.0000000000002423.
PubMed 32555023Kohlbrenner D, Benden C, Radtke T. The 1-Minute Sit-to-Stand Test in Lung Transplant Candidates: An Alternative to the 6-Minute Walk Test. Respir Care. 2020 Apr;65(4):437-443. doi: 10.4187/respcare.07124. Epub 2019 Oct 22.
PubMed 31641072Tarrant BJ, Robinson R, Le Maitre C, Poulsen M, Corbett M, Snell G, Thompson BR, Button BM, Holland AE. The Utility of the Sit-to-Stand Test for Inpatients in the Acute Hospital Setting After Lung Transplantation. Phys Ther. 2020 Jul 19;100(7):1217-1228. doi: 10.1093/ptj/pzaa057.
PubMed 32280975Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. doi: 10.1111/j.1553-2712.2003.tb01355.x.
PubMed 12670856Wyser C, Stulz P, Soler M, Tamm M, Muller-Brand J, Habicht J, Perruchoud AP, Bolliger CT. Prospective evaluation of an algorithm for the functional assessment of lung resection candidates. Am J Respir Crit Care Med. 1999 May;159(5 Pt 1):1450-6. doi: 10.1164/ajrccm.159.5.9809107.
PubMed 10228110Weiner P, Man A, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D, Greiff Y. The effect of incentive spirometry and inspiratory muscle training on pulmonary function after lung resection. J Thorac Cardiovasc Surg. 1997 Mar;113(3):552-7. doi: 10.1016/S0022-5223(97)70370-2.
PubMed 9081102Schnapp LM, Cohen NH. Pulse oximetry. Uses and abuses. Chest. 1990 Nov;98(5):1244-50. doi: 10.1378/chest.98.5.1244.
PubMed 2225973Rossi L, Boffano M, Comandone A, Ferro A, Grignani G, Linari A, Pellegrino P, Piana R, Ratto N, Davis AM. Validation process of Toronto Exremity Salvage Score in Italian: A quality of life measure for patients with extremity bone and soft tissue tumors. J Surg Oncol. 2020 Mar;121(4):630-637. doi: 10.1002/jso.25849. Epub 2020 Jan 19.
PubMed 31957034
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Treatment and Early Recovery After "Wedge Resection" for Pulmonary Metastasis Secondary to Bone Cancer: an Observational Study.
- ClinicalTrials.gov ID
- NCT05310539
- Acronym / sponsor ID
- WEDGE
- Conditions
- Metastasis Lung, Bone Neoplasm
- Keywords
- pulmonary rehabilitation, wedge resection, early recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 5 Apr 2022 (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.
After "wedge resection" surgery, the physiotherapy programs proposed in the literature are heterogeneous and there are few data on the outcomes of such treatments in an oncological population for bone cancer.
The aim of the study is to describe the early rehabilitation process after wedge resection surgery secondary to bone tumor pulmonary mestasasis, highlightining the possible functional recovery in the short and medium term after surgery and indentifying the possible prognostic factors.
Detailed description
In Italy, the incidence of primary bone tumors is around 0.8-1 case per 100,000 inhabitants, therefore an estimated 500 new cases of primary malignant bone tumors are estimated each year, affecting more frequently in children and young people. The presence of pulmonary metastasis occurs in 30% of the population with bone cancer and is the most common site of metastasis. Where possible, the elective treatment of lung metastases is ablative surgery and the wedge resection technique is also commonly used in the event of repeated metastasis over time. Pulmonary wedge resection surgery does not follow the anatomical limits of the lung but it is customized according to the metastatic area to be removed, thus differentiating itself from lobectomies and other thoracotomy surgical techniques.
The trend of vital capacity (CV) and forced expiratory volume in 1s (FEV1), after wedge resection surgery, significantly decrease at 3 months compared to the preoperative evaluation, while at 12 months the CV returns to values close to the preoperative ones and FEV1 remains significantly lower. Rehabilitation treatment is part of the multidisciplinary approach for this type of patient in order to prevent post-surgical respiratory complications (PPC) and shoulder girdle dysfunctions, in the treatment of pain and in the recovery of respiratory volumes. Several authors, describing the physiotherapy treatment techniques, include breathing exercises (Active Cycle Breathing Techniques), early mobilization exercises for the lower limbs and the use of volume incentives. The physiotherapy treatment programs proposed in the literature are heterogeneous and there are no data on the feasibility of such treatments in an oncological population for bone cancer.
Patients are enrolled consecutively in a ward of an italian hospital specialized in bone tumor surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patients admitted to the ward with a diagnosis of pulmonary metastases from bone cancer will be enrolled consecutively for the study.
Key inclusion criteria (3 listed)
- over 12 years of age
- ablative thoracic surgery for metastases localized to the lung and / or chest wall for primary bone cancer
- must be able to perform the "one minute sit-to-stand" test in the preoperative physiotherapy evaluation
Key exclusion criteria (1 listed)
- ablative thoracic surgery for a diagnosis DIFFERENT FROM that of lung metastases
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 |
|---|---|---|
| assessment of the early recovery after wedge resection surgeryTo assess the early recovery will be used 1 minute sit to stand, Numeric Rating scale to assess pain, incentive spirometer to assess vital capacity, Borg modified scale to assess dyspnea. | Other | – |
Primary outcome
1 minute sit to stand (Sixth day after surgery)
Time frame: Sixth day after surgery
The test requires the person to stand up from a chair, without the help of the arms, fully extending their knees, and sit down the greatest number of times in the time of one minute.
6 secondary outcomes
1 minute sit to stand (daily)
Time frame: every day after surgery up to 7 day; at 3, 6 and 12 months after surgery.
pain intensity
Time frame: every day after surgery up to 7 day, twice a day
vital capacity (ml)
Time frame: every day after surgery up to 7 day, twice a day
heart rate (bpm)
Time frame: once a day, before and after 1 minute sit to stand test, up to 7 day
peripheral oxygen saturation (SpO2 %)
Time frame: once a day, before and after 1 minute sit to stand test, up to 7 day
mBorg Score
Time frame: once a day, before and after 1 minute sit to stand test, up to 7 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Background: PubMed 24308680Vijayamurugan N, Bakhshi S. Review of management issues in relapsed osteosarcoma. Expert Rev Anticancer Ther. 2014 Feb;14(2):151-61. doi: 10.1586/14737140.2014.863453. Epub 2013 Nov 26.
- Background: PubMed 31656646Mori S, Shibazaki T, Noda Y, Kato D, Nakada T, Asano H, Matsudaira H, Ohtsuka T. Recovery of pulmonary function after lung wedge resection. J Thorac Dis. 2019 Sep;11(9):3738-3745. doi: 10.21037/jtd.2019.09.32.
- Background: PubMed 30489442Bohannon RW, Crouch R. 1-Minute Sit-to-Stand Test: SYSTEMATIC REVIEW OF PROCEDURES, PERFORMANCE, AND CLINIMETRIC PROPERTIES. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):2-8. doi: 10.1097/HCR.0000000000000336.
- Background: PubMed 27799759Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016.
- Background: PubMed 32555023Tremblay Labrecque PF, Harvey J, Nadreau E, Maltais F, Dion G, Saey D. Validation and Cardiorespiratory Response of the 1-Min Sit-to-Stand Test in Interstitial Lung Disease. Med Sci Sports Exerc. 2020 Dec;52(12):2508-2514. doi: 10.1249/MSS.0000000000002423.
- Background: PubMed 31641072Kohlbrenner D, Benden C, Radtke T. The 1-Minute Sit-to-Stand Test in Lung Transplant Candidates: An Alternative to the 6-Minute Walk Test. Respir Care. 2020 Apr;65(4):437-443. doi: 10.4187/respcare.07124. Epub 2019 Oct 22.
- Background: PubMed 32280975Tarrant BJ, Robinson R, Le Maitre C, Poulsen M, Corbett M, Snell G, Thompson BR, Button BM, Holland AE. The Utility of the Sit-to-Stand Test for Inpatients in the Acute Hospital Setting After Lung Transplantation. Phys Ther. 2020 Jul 19;100(7):1217-1228. doi: 10.1093/ptj/pzaa057.
- Background: PubMed 12670856Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. doi: 10.1111/j.1553-2712.2003.tb01355.x.
- Background: PubMed 10228110Wyser C, Stulz P, Soler M, Tamm M, Muller-Brand J, Habicht J, Perruchoud AP, Bolliger CT. Prospective evaluation of an algorithm for the functional assessment of lung resection candidates. Am J Respir Crit Care Med. 1999 May;159(5 Pt 1):1450-6. doi: 10.1164/ajrccm.159.5.9809107.
- Background: PubMed 9081102Weiner P, Man A, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D, Greiff Y. The effect of incentive spirometry and inspiratory muscle training on pulmonary function after lung resection. J Thorac Cardiovasc Surg. 1997 Mar;113(3):552-7. doi: 10.1016/S0022-5223(97)70370-2.
- Background: PubMed 2225973Schnapp LM, Cohen NH. Pulse oximetry. Uses and abuses. Chest. 1990 Nov;98(5):1244-50. doi: 10.1378/chest.98.5.1244.
- Background: PubMed 31957034Rossi L, Boffano M, Comandone A, Ferro A, Grignani G, Linari A, Pellegrino P, Piana R, Ratto N, Davis AM. Validation process of Toronto Exremity Salvage Score in Italian: A quality of life measure for patients with extremity bone and soft tissue tumors. J Surg Oncol. 2020 Mar;121(4):630-637. doi: 10.1002/jso.25849. Epub 2020 Jan 19.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
marco cotti, pt principal investigator
IOR - Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastasis Lung and Bone Neoplasm, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 1 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: finished, as of the sponsor's last update on 18 Feb 2025. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 minute sit to stand (Sixth day after surgery) (time frame: Sixth day after surgery). 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 NCT05310539, which also lists 12 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 18 Feb 2025.