Clinical trial NCT04145739: The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer Survivors
Official title: The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer Survivors: the Evidences of an Integrated Rehabilitation Protocol During the Oncological Care Path
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Pain, Chronic
Pain, Postoperative
Mastectomy; Lymphedema
Keywords: Breast Cancer
Pain, Chronic and Postoperative
Posture
Target - Reaching movement
Mastectomy
Quadrantectomy
Lymphedema
Rehabilitation
Scapula tilting
Shoulder
Biomechanics
Upper limb
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis behind our study was that patients after BC surgery, who underwent quadrantectomy or mastectomy, may present a different disability respect to the upper limb on the operated side. Accordingly they could have a different functional recovery patterns after rehabilitation.

The aim of our study was to compare the recovery of the fluidity of the reaching movement (Jerk) as the primary outcome, the reduction of shoulder pain and improvement of disability for the upper limb respect the operated side as secondary outcomes, before and after a specific rehabilitation protocol treatment.

Detailed description: Surgery is usually the first line of attack against breast cancer (BC). The decisions about surgery depend on many factors based on the stage, the type of cancer and patient acceptability, in terms of her long term peace of mind and survival prospects. Typically, breast reconstruction takes place during or soon after mastectomy, to avoid psychological distress for the patient, and in some cases, also after lumpectomy or quadrantectomy; furthermore breast reconstruction can be done many months or even years after surgery too.

Today, breast cancer rehabilitation can help survivors to obtain and maintain the highest possible physical, social, psychological and vocational functioning, within the limits created by cancer and its treatments. After BC surgery, is common to detect disorders as shoulder dysfunction, postmastectomy syndrome, chemotherapy-induced peripheral neuropathy, axillary cording, lymphedema and a host of others as postural imbalance.

Also, alterations in muscle activation and restricted shoulder mobility, which are common in BC patients, have been found to affect upper limb function and alterations in muscle activity patterns differed by breast surgery and reconstruction type: rehabilitation and in particular mobilization stretches and shoulder and scapula exercises after breast surgery are an effective resource to improve upper limb range of motion and decrease chest tightness and pain.

This study was prompted by the lack of literature about the quadrantectomy versus mastectomy intervention, considering the disability of the upper limb from the operated side, especially if in relation to the rehabilitation pathway, currently recommended in BC care.

Eligibility criteria: Inclusion Criteria:

* total mastectomy with breast prostheses or tissue expanders performed or quadrantectomy
* age from 18 to 60 years
* body mass index (BMI) \< 30
* no cognitive dysfunctions ( Mini Mental State Examination MMSE \> 24)
* mild lymphedema

Exclusion Criteria:

* presence of lymphangitis or mastitis
* presence of metastasis
* surgical complications of the intervention, neurological deficits and complications
* important shoulder joint problems before the intervention for BC
* severe-moderate lymphedema and web axillary syndrome
* visual problem not corrected by lenses
* other or previous physiotherapy

Primary outcomes:
measure: Time variation of the normalized jerk (NJ) within biomechanical reaching movement
timeFrame: T0 baseline - T1 (30 days) - T2 (3 months)
Secondary outcomes:
measure: Time variation of Visual Analogue Scale (VAS)
timeFrame: T0 baseline - T1 (30 days) - T2 (3 months)
measure: Time variation of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)
timeFrame: T0 baseline - T1 (30 days) - T2 (3 months)
measure: Time variation of Movement Duration (MD) of biomechanical reaching movement
timeFrame: T0 baseline - T1 (30 days) - T2 (3 months)
measure: Time variation of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement
timeFrame: T0 baseline - T1 (30 days) - T2 (3 months)
measure: Time variation of the angle at elbow at end of movement (AE) within biomechanical reaching movement
timeFrame: T0 baseline - T1 (30 days) - T2 (3 months)
measure: Time variation of the mean value of target-approaching velocity (TAV) within biomechanical reaching movement
timeFrame: T0 baseline - T1 (30 days) - T2 (3 months)
Other outcomes:
measure: Time variation of range of Motion (ROM) of shoulder
timeFrame: T0 baseline - T1 (30 days) - T2 (3 months)
measure: Time variation of muscular strength regards shoulder ROM
timeFrame: T0 baseline - T1 (30 days) - T2 (3 months)
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital
Study officials:
affiliation: University 'Sapienza' of Rome
name: Teresa Paolucci, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: