NCT02475174

Brief Summary

Evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy breast cancer.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

Same day

First QC Date

June 10, 2015

Last Update Submit

June 15, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood flow velocity (Flow velocity in brachial artery and vein)

    Flow velocity in brachial and artery vein

    one day

Secondary Outcomes (1)

  • Volume upper limbs

    one day

Study Arms (2)

Without upper limb elevation

EXPERIMENTAL

Manual lymphatic drainage will be held with the voluntary supine without upper limb elevation.

Other: Without upper limb elevation

Upper limb elevation to 30º

EXPERIMENTAL

Manual lymphatic drainage will be held with the voluntary supine with the upper limb elevation to 30º.

Other: Upper limb elevation to 30º

Interventions

Lymphatic drainage without elevation of the upper limb.

Without upper limb elevation

Lymphatic drainage with elevation of the upper limb to 30º.

Upper limb elevation to 30º

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with axillary lymphadenectomy surgery
  • Lymphedema
  • Aged 40-60 years.

You may not qualify if:

  • Women with muscle-tendon injury and / or joint injuries member
  • Skin disorders
  • circulatory diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lais Mara Siqueira das Neves

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 18, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2015

Study Completion

March 1, 2016

Last Updated

June 18, 2015

Record last verified: 2015-06