Clinical Trials Logo

Clinical Trial Summary

This study emphasizes the importance of rehabilitation in breast cancer survivors after mastectomy, even during the course of radiotherapy and chemotherapy, both for good efficacy in reducing pain and for functional recovery of the upper limb. Authors designed a randomized-controlled trial to compare two different rehabilitation protocols: the single rehabilitative treatment (ST) and the group treatment (GT). The study is the first attempt to measure the reaching movement after BC surgery with an optoelectronic evaluation system previously standardized in the neurological field during rehabilitation treatment.


Clinical Trial Description

Breast cancer (BC) is the most common cancer in women in the developed world. Surgery and medical protocols have improved significantly over the last 10 years and this guarantees a better chance of survival and an improvement in quality of life.

Then, the focus on "what happen after defeating BC" has become current: patients' and physicians' awareness of the sequelae of BC surgery has increased, especially in the case of mastectomy or modified radical mastectomy. A large number of these complications, such as lymphedema or post-treatment pain with or without functional impotence, which contribute to limitations in daily life activities, can be treated favourably and, in sometimes, resolved with early rehabilitation protocols. Therefore, it is not only important to start the rehabilitation process early after surgery, but, also, during the sub-acute phase, choose appropriate exercise programs to allow recovery in "quantity" and "quality" of the movement of the operated upper limb (UL). Alterations in muscle activation and reduced shoulder mobility are common in patients with BC. It is necessary to consider that winged scapula incidence in BC surgery is 8% and the prevalence decreased during 6 months after surgery. In particular, patients who developed winged scapula had more shoulder flexion, adduction and abduction limitation. These findings suggest that, after BC surgery, soft tissues restrictions obstruct short-term scapula motion.

Reaching movement is a complex multi-articular movement towards a defined point in space and allows the hand to interact with the environment. Nevertheless, it is not yet investigated during the rehabilitation process. Moreover, the execution of the UL movements, improves if the numerous perturbations of the musculoskeletal system, which occur during the execution of movements, are compensated. Motor synergy's components should modify their action to influence positively the outcome of motor activity, preventing the mistakes of the individual components from influencing the overall activity. An important issue is represented by the redundancy of the degrees of motor freedom. Actions and movements can be performed in different ways because the functional synergies are able to co-vary, without changing the result of the action. However, only three spatial dimensions are needed to specify any position where the hand could be placed. This excess of kinematic degrees of freedom means that there are multiple arm configurations that correspond to any particular position of the hand. Thus, improvements in reaching, after BC mastectomy, can be determined, compared to a different rehabilitation protocol, by comparing the Single rehabilitative Treatment (ST) with Group Treatment (GT). Authors designed a randomized-controlled trial to check if specific scapula exercises, included in the ST, could induce changes in the fluidity of the reaching, called Jerk (primary outcome), decrease shoulder pain and improve the functioning of the operated upper limb (secondary outcomes). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04166279
Study type Interventional
Source University of Roma La Sapienza
Contact
Status Completed
Phase N/A
Start date January 8, 2018
Completion date July 19, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2