Early Recovery After "Wedge Resection" Surgery to Remove Lung Mestastasis Secondary to Bone Cancer.

Bone Neoplasm Clinical Trial

Official title:

Rehabilitation Treatment and Early Recovery After "Wedge Resection" for Pulmonary Metastasis Secondary to Bone Cancer: an Observational Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05310539
• Other study ID #: WEDGE
• Status: Recruiting
• Start date: January 8, 2022
• Est. completion date: January 8, 2026

Study information

• Verified date: February 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: marco cotti, pt
• Phone: 00390516366354
• Email: marco.cotti[@]ior.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 8, 2026
• Est. primary completion date: January 8, 2024
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• ablative thoracic surgery for a diagnosis DIFFERENT FROM that of lung metastases

Related Conditions & MeSH terms

• Bone Neoplasm
• Bone Neoplasms
• Metastasis Lung
• Neoplasm Metastasis

Intervention

Other:
• assessment of the early recovery after wedge resection surgery
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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (12)

Bijur 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. — View Citation

Bohannon 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. — View Citation

Kohlbrenner 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. — View Citation

Mori 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. — View Citation

Rossi 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. — View Citation

Schnapp LM, Cohen NH. Pulse oximetry. Uses and abuses. Chest. 1990 Nov;98(5):1244-50. doi: 10.1378/chest.98.5.1244. — View Citation

Tarrant 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. — View Citation

Tremblay 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. — View Citation

Vaidya 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. — View Citation

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. — View Citation

Weiner 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. — View Citation

Wyser 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Sixth day after surgery
Secondary	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.	every day after surgery up to 7 day; at 3, 6 and 12 months after surgery.
Secondary	pain intensity	numeric rating scale (from 0 (no pain) to 10 (worst possible pain))	every day after surgery up to 7 day, twice a day
Secondary	vital capacity (ml)	the vital capacity will be assess with incentive spirometer named "respirex"	every day after surgery up to 7 day, twice a day
Secondary	heart rate (bpm)	beats per minute; it will be assess with pulse oximeter	once a day, before and after 1 minute sit to stand test, up to 7 day
Secondary	peripheral oxygen saturation (SpO2 %)	it will be assess with pulse oximeter	once a day, before and after 1 minute sit to stand test, up to 7 day
Secondary	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).	once a day, before and after 1 minute sit to stand test, up to 7 day