Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery

NCT ID: NCT03796845

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 465 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-12-20

Brief Summary

Randomized clinical trial that will include women aged 18 or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA). Patients will be allocated into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points). Sociodemographic and clinical data will be collected through interviews, questionnaires and electronic and physical records. The outcomes will be incidence of operative wound complications, like edema, joint restraint, winged scapula, pain, axillary web syndrome through the physical examination, performed by the nursing and physiotherapy team throughout the intervention period, ending in the 30-day post-operatory.

Detailed Description

Breast cancer treatment has been accompanying advances in technology, surgeries are more conservative, however postoperative complications are still observed. At early postoperative period, the most common operative wound complications are seroma, infection and necrosis. Shoulder dysfunctions are a frequent complication and difficult women to return to their activities. There is no consensus regarding the onset and type of exercise in postoperative period. Thus, the objective of this study is to compare the active no-limited mobilization with limited mobilization in the immediate post operatory at the incidence of wound complications in women submitted to surgery for the treatment of breast cancer.

It's a randomized clinical trial that will include women aged 18 years or older, submitted a curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA) located in Rio de Janeiro. All patients admitted for surgical treatment at the institution and during the study period will be evaluated for eligibility criteria. Those considered eligible for the study will be clarified regarding the objectives, treatment groups, adverse effects and non-compulsory participation of the study. Upon acceptance to participate, they will be allocated to the respective intervention groups. Group 1 - upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder; Group 2 - upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No-limited movement after surgery

Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.

Group Type: EXPERIMENTAL

No limited movement after surgery

Intervention Type: OTHER

Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.

Limited movement after surgery

Participants should move their arms with restricted movements on the first postoperative day, with maximum amplitude of 90º for flexion and abduction of the shoulder, until withdrawal surgical points. Actual hospital's routine.

Group Type: ACTIVE_COMPARATOR

No limited movement after surgery

Intervention Type: OTHER

Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.

Interventions

No limited movement after surgery

Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women aged 18 and over;
• Indication of curative surgical treatment for breast cancer axillary approach at Hospital do Câncer III / INCA.

Exclusion Criteria

• Bilateral breast cancer;
• Surgical treatment and / or previous radiotherapy for breast cancer;
• Reconstruction surgery;
• Functional alteration in upper limbs prior to diagnosis of breast cancer;
• Illiterate women who are not able to read and complete the protocol of adhesion;
• Women who are not able to answer questions clearly;
• Age over 80.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Nacional de Cancer, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anke Bergmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anke Bergmann

Role: PRINCIPAL_INVESTIGATOR

CPQ - INCA

Locations

Clarice Gomes Chagas Teodozio

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

Teodozio CGC, Marchito LO, Fabro EAN, Macedo FO, de Aguiar SS, Thuler LCS, Bergmann A. Shoulder amplitude movement does not influence postoperative wound complications after breast cancer surgery: a randomized clinical trial. Breast Cancer Res Treat. 2020 Nov;184(1):97-105. doi: 10.1007/s10549-020-05826-9. Epub 2020 Aug 17.

Reference Type: DERIVED

PMID: 32804282 (View on PubMed)

Other Identifiers

Shoulder exercise cancer

Identifier Type: -

Identifier Source: org_study_id