Clinical Trial With Two Physical Therapy Protocols After Breast Cancer Surgery and Immediate Reconstruction

NCT02480842 | Completed

• 1 other identifier: FUSaoPaulo PT 3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: physical therapy is essential in preventing motor and functional complications after breast cancer surgery. However, there is no prospective randomized study of different physiotherapy approaches in patients undergoing breast cancer surgery with immediate reconstruction. Objectives: to evaluate two physical therapy protocols in patients after breast cancer surgery with immediate reconstruction. A group with shoulder exercises with limited range of motion (ROM) at 90 degrees up to a month after surgery and a group with limited ROM only up to 15 days after surgery. Specific objectives: to evaluate shoulder ROM and pain one week before the surgery on average, and 07, 15, 30, 60, 90 and 180 days after surgery; assess motor function one week before the surgery on average, and 30 and 90 days after surgery; evaluate dehiscence and seroma 07, 15, 30, 60 and 90 days after surgery; associate incidence of seroma and dehiscence with preoperative risk factors and compare all variables (shoulder ROM, pain, motor function, seroma and dehiscence) between the two groups. Methods: women with breast cancer, who will be submitted to breast surgery (radical or conservative), followed by immediate reconstruction: alloplastic (tissue expander or breast implant) or oncoplastic (breast reduction or contralateral symmetrization) will be included. Patients that will be submitted to bilateral oncology surgery, reconstruction with autologous tissue or breast surgery without reconstruction will not be included. Patients will be recruited just after surgery scheduling and will undergo preoperative evaluation. At this moment, preoperative analysis will be conducted with personal data and medical history. Patients will undergo new assessments 07, 15, 30, 60, 90 and 180 days after surgery. All patients will receive standard physiotherapy treatment for women undergoing breast reconstruction from Physical Therapy Sector. The protocol consists of early exercise, limited to 90° of shoulder ROM, starting the day after the surgery and repeated 7 days after surgery. After 15 days of surgery, the patients will be randomized into two treatment protocols. One group will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain. The other group will keep shoulder exercises limited to 90° up to 30 days after surgery. At that moment (one month after surgery), they will also be allowed to move the shoulder with no restriction. The evaluation of the presence of dehiscence and seroma will occur by inspection and palpation. Shoulder ROM will be investigated through active goniometry of flexion, extension, adduction, abduction, internal rotation and external rotation. The pain will be assessed with the Verbal Numerical Scale from 0 to10 and upper limb function through the DASH (Disabilities of the Arm, Shoulder and Hand Questionnaire) questionnaire.

Conditions

Breast Neoplasms

Keywords

Breast Neoplasms; Mammaplasty; Breast Implantation; Range of Motion, Articular; Shoulder Joint; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (6)

• Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 07 days after surgery assessment

  The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  One week before surgery on average and 07 days after surgery

• Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 15 days after surgery assessment

  The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  One week before surgery on average and 15 days after surgery

• Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment

  The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  One week before surgery on average and 30 days after surgery

• Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 60 days after surgery assessment

  The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  One week before surgery on average and 60 days after surgery

• Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment

  The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  One week before surgery on average and 90 days after surgery

• Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 180 days after surgery assessment

  The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  One week before surgery on average and 180 days after surgery

Secondary Outcomes (18)

• Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 07 days after surgery assessment

  One week before surgery on average and 07 days after surgery

• Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 15 days after surgery assessment

  One week before surgery on average and 15 days after surgery

• Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment

  One week before surgery on average and 30 days after surgery

• Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 60 days after surgery assessment

  One week before surgery on average and 60 days after surgery

• Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment

  One week before surgery on average and 90 days after surgery

Study Arms (4)

Alloplastic group A

EXPERIMENTAL

After randomization (15 days after surgery): \- Patients will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain.

Other: Alloplastic free ROM

Alloplastic group B

EXPERIMENTAL

After randomization (15 days after surgery): \- Patients will keep shoulder exercises limited to 90° up to 30 days after surgery. At that moment (one month after surgery), then patients will also be allowed to move the shoulder with no restriction

Other: Alloplastic limited ROM

Oncoplastic group A

EXPERIMENTAL

After randomization (15 days after surgery): \- Patients will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain.

Other: Oncoplastic free ROM

Oncoplastic group B

EXPERIMENTAL

After randomization (15 days after surgery): \- Patients will keep shoulder exercises limited to 90° up to 30 days after surgery. At that moment (one month after surgery), then patients will also be allowed to move the shoulder with no restriction

Other: Oncoplastic limited ROM

Interventions

Alloplastic free ROM OTHER

Alloplastic group A

Alloplastic limited ROM OTHER

Alloplastic group B

Oncoplastic free ROM OTHER

Oncoplastic group A

Oncoplastic limited ROM OTHER

Oncoplastic group B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with breast cancer, who will be submitted to breast surgery (radical or conservative), followed by immediate reconstruction: alloplastic (tissue expander or breast implant) or oncoplastic (breast reduction or contralateral symmetrization).

You may not qualify if:

• Patients that will be submitted to bilateral oncology surgery, reconstruction with autologous tissue or breast surgery without reconstruction. Patients with motor or neurological deficits prior to surgery, with cognitive impairment and those that do not accept to participate.
• Patients who need to undergo new surgical procedures during the postoperative follow-up period and those who do not appear to postoperative evaluations

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, 04024002, Brazil

Location

Related Publications (1)

• de Almeida Rizzi SKL, Haddad CAS, Giron PS, Figueira PVG, Estevao A, Elias S, Nazario ACP, Facina G. Early Free Range-of-Motion Upper Limb Exercises After Mastectomy and Immediate Implant-Based Reconstruction Are Safe and Beneficial: A Randomized Trial. Ann Surg Oncol. 2020 Nov;27(12):4750-4759. doi: 10.1245/s10434-020-08882-z. Epub 2020 Jul 28.

  PMID: 32725529 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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: FUSaoPaulo PT3

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 25, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 17, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

BR (1)