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

U

University of Roma La Sapienza

Status

Completed

Conditions

Breast Cancer
Pain, Postoperative
Pain, Chronic
Mastectomy; Lymphedema

Treatments

Other: Rehabilitation protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT04145739
URomLS-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 2 patient groups

Mastectomy group
Experimental group
Description:
Patients undergoing mastectomy
Treatment:
Other: Rehabilitation protocol
Quadrantectomy group
Experimental group
Description:
Patients undergoing quadrantectomy
Treatment:
Other: Rehabilitation protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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