The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer Survivors

NCT04145739 | Completed

• 1 other identifier: URomLS-2019
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Time variation of the normalized jerk (NJ) within biomechanical reaching movement

  The normalized jerk (NJ) was evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), calculated on the wrist-target marker distance, within the reaching task performed on the side underwent surgery. It measures the fluidity of the upper limb movement.

  T0 baseline - T1 (30 days) - T2 (3 months)

Secondary Outcomes (6)

• Time variation of Visual Analogue Scale (VAS)

  T0 baseline - T1 (30 days) - T2 (3 months)

• Time variation of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)

  T0 baseline - T1 (30 days) - T2 (3 months)

• Time variation of Movement Duration (MD) of biomechanical reaching movement

  T0 baseline - T1 (30 days) - T2 (3 months)

• Time variation of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement

  T0 baseline - T1 (30 days) - T2 (3 months)

• Time variation of the angle at elbow at end of movement (AE) within biomechanical reaching movement

  T0 baseline - T1 (30 days) - T2 (3 months)

Other Outcomes (2)

• Time variation of range of Motion (ROM) of shoulder

  T0 baseline - T1 (30 days) - T2 (3 months)

• Time variation of muscular strength regards shoulder ROM

  T0 baseline - T1 (30 days) - T2 (3 months)

Study Arms (2)

Mastectomy group

EXPERIMENTAL

Patients undergoing mastectomy

Other: Rehabilitation protocol

Quadrantectomy group

EXPERIMENTAL

Patients undergoing quadrantectomy

Other: Rehabilitation protocol

Interventions

Rehabilitation protocol OTHER

The rehabilitation treatment was performer in single session, lasted 60 minutes for session, 2 times a week, carried-out a 6-week exercises program for a total of 12 sessions, by a physiotherapist trained in oncologic rehabilitation, who started with a first phase of at least 15-20 min of low-impact aerobics warm-up. The second phase consisted in diaphragmatic breathing and postural exercises for the midline alignment in a supine position. Finally the patient continued in front of the mirror with exercises for the recovery of shoulder joint, isometric reinforcement exercises for the recovery of strength of shoulder stabilizer muscles. In the presence of lymphedema an additional weekly lymph drainage session was performed for a total of 10 sessions.

Mastectomy group; Quadrantectomy group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Umberto I Hospital

Rome, 00165, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain; Pain, Postoperative; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Teresa Paolucci, MD, PhD

  University 'Sapienza' of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 31, 2019
• Study Start: April 23, 2018
• Primary Completion: February 4, 2019
• Study Completion: April 15, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-09

Locations

IT (1)