Clinical trial NCT03796845: Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery
Official title: Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Exercise
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
First posted: 2019-01-08
Enrollment: 465
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Presence or absence of wound complications.
timeFrame: Thirty days of follow-up
Secondary outcomes:
measure: Measurement of upper limb functionality
timeFrame: Thirty days of follow-up
measure: Measurement of shoulder's range of motion
timeFrame: Thirty days of follow-up
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Clarice Gomes Chagas Teodozio
state: RJ
Study officials:
affiliation: CPQ - INCA
name: Anke Bergmann
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.