Breast Neoplasms Clinical Trial
— exerciseOfficial title:
Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery
Verified date | April 2020 |
Source | Instituto Nacional de Cancer, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 465 |
Est. completion date | December 20, 2019 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Clarice Gomes Chagas Teodozio | Rio de Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cancer, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Measurement of upper limb functionality | Performed routinely by physical therapy using the upper limb functionality questionnaire (Disabilities of the arm, shoulder and hand - DASH) during the first month after the surgical procedure. It is a validated, reliable and translated into Portuguese questionnaire. It has 30 items classified from 1 to 5, and aims to grade physical function and symptoms in people with any upper limb dysfunction. The total score ranges from 0 (no dysfunction) to 100 (severe dysfunction). | Thirty days of follow-up | |
Secondary | Measurement of shoulder's range of motion | Performed routinely by the physiotherapist through physical examination of the range of motion of the shoulder during the first month after the surgical procedure. | Thirty days of follow-up |
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