Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery

NCT03796845 | Completed DMC

• 1 other identifier: Shoulder exercise cancer
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• Presence or absence of wound complications.

  Occurrence of wound complications (necrosis, dehiscence, seroma, infection or hematoma) will be obtained by the physical examination, performed routinely by the nursing and physiotherapy during the first month after the surgical procedure.

  Thirty days of follow-up

Secondary Outcomes (2)

• Measurement of upper limb functionality

  Thirty days of follow-up

• Measurement of shoulder's range of motion

  Thirty days of follow-up

Study Arms (2)

No-limited movement after surgery

EXPERIMENTAL

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

Other: No limited movement after surgery

Limited movement after surgery

ACTIVE COMPARATOR

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.

Other: No limited movement after surgery

Interventions

No limited movement after surgery 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; No-limited movement after surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Clarice Gomes Chagas Teodozio

Rio de Janeiro, Rio de Janeiro, 20230240, Brazil

Location

Related Publications (1)

• 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.

  PMID: 32804282 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Anke Bergmann

  CPQ - INCA

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Patients submitted to surgery for breast cancer 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).

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: January 8, 2019
• Study Start: February 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: December 20, 2019
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)