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Sarcoma, Soft TissueSTART-RUN1NCT06873685

Soft Tissue Sarcoma: Motor Performance, Robotic Rehabilitation, Nutrition, and Quality of Life

A study testing Rehabilitation in people with Sarcoma, Soft Tissue, run by Fondazione Policlinico Universitario Campus Bio-Medico at 3 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Soft tissue sarcomas are a group of rare and heterogeneous tumors. Surgery is the mainstay of treatment and microscopic negative margins need to be achieved to improve disease local control. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma, Soft Tissue
What is being tested?
Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesItaly
Study dates
13 Mar 2025to 31 Aug 2026
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patient with primary and localized STS who is a candidate for limb-sparing surgery or retroperitoneal multivisceral resection (including partial or complete resection of the iliopsoas muscle with functional loss and potential femoral nerve involvement) with curative intent;
  • age 18 years or older.

Who cannot join

  • recurrent tumors;
  • metastatic disease;
  • candidate for palliative and non-radical surgery;
  • refusal to sign informed consent;
  • Pregnant or breastfeeding women at the time of screening.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bruno Vincenzi contact

+3906225411160

b.vincenzi@policlinicocampus.it

Italy3 sites, 2 recruiting

  • Istituto Nazionale Tumori-IRCCS-Fondazione G.Pascale

    Naples, 80131

    Monica Pinto, MD, +393384790798, m.pinto@istitutotumori.na.it

    Not yet recruiting

  • Fondazione Don Carlo Gnocchi ONLUS

    Roma, RM, 00166

    Active, not recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Rome, Lazio, 00128

    Cinzia Potestà, +3906225418855, c.potesta@policlinicocampus.it

    Recruiting

Other trials in Italy

About this study

Official title: Soft Tissue Sarcoma: Instrumented Evaluation of Motor Performance and Impact of Robotic Rehabilitation, Nutrition and Quality of Life Assessment (START-RUN1)

Soft tissue sarcomas are a group of rare and heterogeneous tumors. Surgery is the mainstay of treatment and microscopic negative margins need to be achieved to improve disease local control. We designed this prospective study to evaluate the main features of motor impairment and the impact of tailored robotic rehabilitation techniques in patients treated for localized soft tissue sarcoma (surgery alone, or surgery + radiation or radiochemotherapy). Specific patients' motor strategies will be quantitatively measured through a biomechanical assessment, including the analysis of joint kinematics, and muscle activity timing patterns. Considering the influence of motor impairment after demolitive surgery, a major interest of this study will be focused on nutrition and Quality of life which will be prospectively evaluated by specific questionnaires at different time points.

Read the detailed description

This is a non-profit, multicenter, non-controlled interventional study aimed at evaluating the main characteristics of motor disability and the impact of personalized robotic rehabilitation in patients undergoing surgical treatment for localized soft tissue sarcoma (STS).

Aim 1: Identify the clinical characteristics and motor deficits following surgical intervention for soft tissue sarcoma (STS).

Aim 2: Evaluate the impact of a personalized robotic rehabilitation treatment on motor recovery in patients with STS.

Aim 3: Assess the impact of perioperative treatments and surgery on quality of life and nutritional status in patients with STS.

The primary endpoint of the study is the assessment of functional deficits and motor quality in patients with STS who have undergone surgical treatment, both after surgery and after a personalized rehabilitation program. The evaluation of functional deficits will include the analysis of functional impairment, activity limitations, and pain, which will be assessed using validated clinical scales. Motor quality will be measured using MIMU and EMG sensors and motor tests to study muscle activity.

The secondary endpoints will include:

  1. a comprehensive patient and disease assessment, recording: demographic information and patient characteristics; past medical history; tumor location; histopathological tumor characteristics; details on neoadjuvant therapies and surgical procedures.
  2. the Quality of life assessment of the patients;
  3. the nutritional status assessment of the patients.

Study Procedures and Interventions:

Comprehensive assessments-including general, clinical, instrumental, quality of life, and nutritional evaluations-will be conducted at:

T0 (at diagnosis) to establish aims to characterize the impact of the tumor on the patient's functional abilities.

T0+ (after radio-chemotherapy, if applicable) to assess the potential effects of radio-chemotherapy before surgery.

Patients eligible for rehabilitation treatment will follow a structured evaluation process:

T1 (within one month after surgery): reassessment to determine the functional impact of surgery.

Rehabilitation phase: Patients will undergo conventional and robotic rehabilitation therapies tailored to the upper or lower limbs.

T2 (after two months of rehabilitation): reassessment to measure functional recovery and rehabilitation outcomes.

T3 (within eight-months from surgery): follow-up.

The sample size was calculated based on a change after the rehabilitation program at least equal to the MCID of the scale. Specifically, 67 individuals are necessary considering a 2-sided, paired t-test, an MCID of 7 points, a common standard deviation of 20 points, a correlation coefficient between paired samples of 0.5, a significance threshold of 0.05, and a power of 0.80. This sample size will be increased to 90 individuals to account for a 25% loss at T2 owing to patients who will be unable to begin the rehabilitation intervention or who will develop clinical complications during the rehabilitation intervention. The power calculation was limited to patients with RPS and lower limb ESTS since the MCID of the TESS for the upper limb module has not been published. Moreover, we will enroll 30 patients with upper limb ESTS, based on number of patients referred and operated at our units (UO1 and UO3) in the last 2 years. Findings achieved in these patients will be considered exploratory for the scanty information currently available in the literature.

All participating centers will follow a standardized operating procedure regarding treatment and outcome assessment to ensure consistency across all sites. Data will be systematically collected using the REDCap (Research Electronic Data Capture) platform.

Being tested
Rehabilitation
Keywords
rehabilitation, nutrition, quality of life, instrumented assessment of motor performance
Medical subject headings
Sarcoma

What participants receive

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

  • RehabilitationOther

    After surgery, patients will undergo a personalized rehabilitation program incorporating both conventional and robotic-based approaches. Depending on tumor location, rehabilitation will focus on either the upper or lower limbs.

    For lower limb rehabilitation, robotic or technological devices will be utilized for gait training with bodyweight support, as well as for balance and proprioception training. Upper limb rehabilitation will involve robotic or sensor-based devices enabling passive, active, and active-assistive movements of the shoulder, elbow, and hand.

    Treatment will be provided in various settings- inpatient, outpatient, or home-based- tailored to each patient's specific needs. Sessions will be conducted daily for 45 minutes, five days per week, over a two-month period.

Study groups in NCT06873685
Study groupRoleWhat they receive
RehabilitationExperimentalConventional and robotic / technological rehabilitation treatments targeting the upper or lower limb, based on tumor location.
Receives: Other: Rehabilitation

What is being measured

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

  1. Change in patients' physical function after the rehabilitation treatment as assessed by the Toronto Extremity Salvage Score (TESS) score

    The Toronto Extremity Salvage Scores is the most commonly used, valid, and disease-specific measure to assess physical function in patients with bone and soft tissue tumors of the extremities undergoing limb salvage surgery. The Italian version will be used. The score ranges from 0 to 100, with 100 being the best score. According to tumor's location, either the upper or the lower limb section will be used. We will employ the Italian version of the TESS.

    Measured: T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment)

Secondary outcomes (28)

  1. Toronto Extremity Salvage Score (TESS)

    The Toronto Extremity Salvage Scores is the most commonly used, valid, and disease-specific measure to assess physical function in patients with bone and soft tissue tumors of the extremities undergoing limb salvage surgery. The Italian version will be used. The score ranges from 0 to 100, with 100 being the best score. According to tumor's location, either the upper or the lower limb section will be used. We will employ the Italian version of the TESS.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  2. Musculoskeletal Tumor Society Rating Scale (MSTS)

    The Musculoskeletal Tumor Society Rating Scale (MSTS) scoring system is a commonly used functional evaluation system for patients who undergo surgery for musculoskeletal tumors. The MSTS system consists of six key criteria, each graded on a five-point scale (0 to 5 points). The total score ranges from 0 to 30 points, where higher scores indicate better functional outcomes. According to tumor's location, either the upper or the lower limb section will be used.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  3. Numerical Pain Rating Scale (NPRS)

    The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).

  4. Brief Pain Questionnaire (BPI)

    The Brief Pain Inventory (BPI) is a rapid tool for assessing clinical pain. It consists of two sections. The first section, composed of four items, assesses pain intensity in different situations (current pain, worst pain, least pain, and average pain). The second section examines the impact of pain on daily life through seven items, covering work, recreational activities, mobility, sleep quality, mood, interpersonal relationships, and overall quality of life. Each item is rated using an 11-point Likert scale, ranging from 0 ("no pain/no interference") to 10 ("maximum pain/maximum interference").

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  5. Douleur Neuropathique en 4 Questions (DN4)

    Douleur Neuropathique en 4 Questions (DN4) questionnaire is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).

  6. Leeds Assessment of Neuropathic Symptoms and Signs Scale (LANSS)

    Leeds Assessment of Neuropathic Symptoms and Signs Scale (LANSS) is a simple clinical tool that can be used to identify pain of predominantly neuropathic origin. Contains 5 symptom items and 2 clinical examination items[1]. For the clinical examination, a cotton wool and 23 gauge needle is required. A score of 12 or above is indicative of predominantly neuropathic pain.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).

  7. Kinematic assessment of motor performance

    Patients' motor strategies will be quantitatively measured through a biomechanical assessment using a network of Magneto-Inertial Measurement Unit (MIMU) sensors, to measure joint kinematics, and spatio-temporal parameters.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).

  8. Surface electromyography (sEMG) assessment

    Patients' motor strategies will be quantitatively evaluated using a surface electromyography (sEMG) system, allowing for the analysis of muscle activation timing patterns.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).

  9. Quality-of-Life Questionnaire (QLQ)-C30

    The European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ-C30 version, is a 30-item instrument designed to measure quality of life in all cancer patients. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.

    Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).

  10. Short Form Health Survey 36 (SF-36) - Physical Composite Score (PCS)

    The Short Form Health Survey 36 (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. The Physical Component Score (PCS) score is a composite measure that reflects an individual's overall physical health status. It ranges from 0 to 100. Higher scores indicate better physical health and fewer limitations, while lower scores reflect greater physical impairment.

    Measured: T0 (1 week before surgery), T0+ (after after radiochemotherapy, if administered before surgery), T1 (1 months after surgery) and T2 (after 2 months of rehabilitation treatment), T3 (follow up, within 8 months after surgery)

  11. Short Form Health Survey 36 (SF-36) - Mental Composite Score (MCS)

    The Short Form Health Survey 36 (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. The Mental Composite Score (MCS) is a composite measure that reflects an individual's overall mental status. It ranges from 0 to 100, with 0 representing the worst possible mental health and 100 representing the best possible mental health..

    Measured: T0 (1 week before surgery), T0+ (after after radiochemotherapy, if administered before surgery), T1 (1 months after surgery) and T2 (after 2 months of rehabilitation treatment), T3 (follow up, within 8 months after surgery)

  12. PREDIMED questionnaire

    The PREDIMED 14-item questionnaire is a rapid screening tool designed to assess adherence to the Mediterranean diet. Each of the 14 items is a yes/no question, with responses scored as follows: 1 point for a response indicating adherence to a Mediterranean diet principle; 0 points for a response indicating non-adherence. The total score ranges from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet.

    Measured: T0 (1 week before surgery)

  13. Food diary compilation

    Patients' compilation of a Food Diary registering 3 non-consecutive days per week ( as for NIH, National Cancer Institute, Dietary assessment Primer)

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  14. Weight in kilograms

    It is a measure of body mass weight expressed in Kg

    Measured: T0 (1 week before surgery), T0+ (after after radiochemotherapy, if administered before surgery), T1 (1 months after surgery) and T2 (after 2 months of rehabilitation treatment), T3 (follow up, within 8 months after surgery)

  15. Height in meters

    It is a measure of body height expressed in meters.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  16. Body mass Index in kg/(m^2)

    It is a measure which combines the height and weight values to report Body Mass Index (BMI) expressed in kg/m²; this parameter is valid for adult men and women.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  17. Arm circumferences expressed in cm

    Measures of arm circumferences expressed in cm.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  18. Waist circumferences expressed in cm

    Measures of waist circumferences expressed in cm.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  19. Hips circumferences expressed in cm

    Measures of hips circumferences expressed in cm.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  20. Bioimpedance analysis (BIA) measurements

    it is a non-invasive measurement of body fat, lean muscle mass and hydration

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  21. Concentration of blood levels of haemoglobin in g/dL

    Blood measurements of haemoglobin (g/dL) measured with colorimetric method.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  22. Concentration of blood levels of lymphocite expressed in count of cells or percentage

    Blood measurements of total lymphocyte in count of cells or percentage

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  23. Concentration of albumine serum levels in g/dL

    Serum measurements of albumin in g/dL measured with colorimetric method.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  24. Concentration of total cholesterol serum levels in mg/dL

    Serum measurements of total cholesterol in mg/dL measured with colorimetric method.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  25. Concentration of serum C-reactive protein (CRP)

    Serum measurements of C-reactive protein mg/dL measured with colorimetric method.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  26. Concentration of glucose serum levels in mg/dL

    Serum measurements of glucose in mg/dL measured with colorimetric method.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  27. Controlling Nutritional Status (CONUT)

    The Controlling Nutritional Status (CONUT) is a nutritional scoring tool that is calculated using serum concentration of: albumin, total cholesterol level, total lymphocyte count

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

  28. Nutritional Risk Index score (NRI)

    The Nutritional Risk Index score (NRI) is a nutritional index calculated from measurements of weight and concentration of serum albumin.

    Measured: T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery)

Timeline

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

  1. First posted13 Mar 2025
  2. Study start13 Mar 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Aug 2026 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06873685
Sponsor's protocol ID
FPUCBM_STARTRUN1
Other IDs
PNRR-TR1-2023-12378226
Acronym
START-RUN1
Status last verified
Feb 2025
First submitted
10 Feb 2025
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McKenzie C, Barker K. Occupational therapy rehabilitation for sarcoma patients following limb salvage surgery: a scoping review. Disabil Rehabil. 2021 Jan;43(2):284-296. doi: 10.1080/09638288.2019.1620874. Epub 2019 Jun 10.

    PubMed 31180732

  • Tanaka A, Okamoto M, Kito M, Yoshimura Y, Aoki K, Suzuki S, Takazawa A, Komatsu Y, Ideta H, Ishida T, Takahashi J. Muscle strength and functional recovery for soft-tissue sarcoma of the thigh: a prospective study. Int J Clin Oncol. 2023 Jul;28(7):922-927. doi: 10.1007/s10147-023-02348-4. Epub 2023 May 3.

    PubMed 37133781

  • Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.

    PubMed 16000093

  • van Eck I, den Hollander D, Desar IME, Soomers VLMN, van de Sande MAJ, de Haan JJ, Verhoef C, Vriens IJH, Bonenkamp JJ, van der Graaf WTA, van Houdt WJ, Husson O. Unraveling the Heterogeneity of Sarcoma Survivors' Health-Related Quality of Life Regarding Primary Sarcoma Location: Results from the SURVSARC Study. Cancers (Basel). 2020 Oct 22;12(11):3083. doi: 10.3390/cancers12113083.

    PubMed 33105807

  • Slump J, Bastiaannet E, Halka A, Hoekstra HJ, Ferguson PC, Wunder JS, Hofer SOP, O'Neill AC. Risk factors for postoperative wound complications after extremity soft tissue sarcoma resection: A systematic review and meta-analyses. J Plast Reconstr Aesthet Surg. 2019 Sep;72(9):1449-1464. doi: 10.1016/j.bjps.2019.05.041. Epub 2019 May 23.

    PubMed 31302071

  • 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.

    PubMed 31957034

  • Poquet N, Lin C. The Brief Pain Inventory (BPI). J Physiother. 2016 Jan;62(1):52. doi: 10.1016/j.jphys.2015.07.001. Epub 2015 Aug 21. No abstract available.

    PubMed 26303366

  • Pavlidis ET, Pavlidis TE. New trends in the surgical management of soft tissue sarcoma: The role of preoperative biopsy. World J Clin Oncol. 2023 Feb 24;14(2):89-98. doi: 10.5306/wjco.v14.i2.89.

    PubMed 36908679

  • Ogura K, Uehara K, Akiyama T, Shinoda Y, Iwata S, Tsukushi S, Kobayashi E, Hirose T, Yonemoto T, Endo M, Tanzawa Y, Nakatani F, Kawano H, Tanaka S, Kawai A. Minimal clinically important differences in Toronto Extremity Salvage Score for patients with lower extremity sarcoma. J Orthop Sci. 2020 Mar;25(2):315-318. doi: 10.1016/j.jos.2019.03.022. Epub 2019 Apr 16.

    PubMed 31000377

  • Martinez-Gonzalez MA, Garcia-Arellano A, Toledo E, Salas-Salvado J, Buil-Cosiales P, Corella D, Covas MI, Schroder H, Aros F, Gomez-Gracia E, Fiol M, Ruiz-Gutierrez V, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Munoz MA, Warnberg J, Ros E, Estruch R; PREDIMED Study Investigators. A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial. PLoS One. 2012;7(8):e43134. doi: 10.1371/journal.pone.0043134. Epub 2012 Aug 14.

    PubMed 22905215

  • Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev. 2016 May 3;1:2. doi: 10.1186/s41073-016-0007-6. eCollection 2016.

    PubMed 29451543

  • Fayers P, Bottomley A; EORTC Quality of Life Group; Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33. doi: 10.1016/s0959-8049(01)00448-8.

    PubMed 11858978

  • Enneking WF, Dunham W, Gebhardt MC, Malawar M, Pritchard DJ. A system for the functional evaluation of reconstructive procedures after surgical treatment of tumors of the musculoskeletal system. Clin Orthop Relat Res. 1993 Jan;(286):241-6.

    PubMed 8425352

  • Davis AM, Wright JG, Williams JI, Bombardier C, Griffin A, Bell RS. Development of a measure of physical function for patients with bone and soft tissue sarcoma. Qual Life Res. 1996 Oct;5(5):508-16. doi: 10.1007/BF00540024.

    PubMed 8973131

  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

    PubMed 31081853

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation in people with Sarcoma, Soft Tissue, run by Fondazione Policlinico Universitario Campus Bio-Medico at 3 sites 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 2 inclusion and 5 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

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 Bruno Vincenzi (+3906225411160, b.vincenzi@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patients' physical function after the rehabilitation treatment as assessed by the Toronto Extremity Salvage Score (TESS) score (time frame: T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment)). 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 NCT06873685, which also lists 22 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 21 Mar 2025.

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