Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03584100
Other study ID # IRB-40228
Secondary ID NCI-2018-01125BR
Status Completed
Phase N/A
First received
Last updated
Start date November 7, 2018
Est. completion date June 30, 2020

Study information

Verified date November 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the proposed study is to evaluate the acute impact of swelling caused by low-pressure tourniquet use in the setting of ipsilateral prior axillary lymph node dissection and the change in swelling reduction following tourniquet use in three limb postures versus healthy volunteers.


Description:

PRIMARY OBJECTIVES: I. To evaluate reduction in swelling and safety of tourniquet use in patients with prior axillary lymph node dissection OUTLINE: Participants raise their arm for 15 minutes, then wear a tourniquet inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position. PROCEDURE: Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Have previously undergone axillary lymph node dissection - Or healthy volunteers Exclusion Criteria: - Have new-onset lymphedema of the involved limb. - Infection including cellulitis - Trauma or planned axillary surgery within 6 months of participation - Any prior axillary radiation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Tourniquet 8000
Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure

Locations

Country Name City State
United States Stanford University School of Medicine Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Hand Volume Following Tourniquet Use Hand volume, as an indicator of limb edema / fluid accumulation, was determined with an aqueous volumeter at rest and for the sling and elevated arm positions 30 minutes after an arm tourniquet was placed. Measurements were taken for the affected arm [ie, after axillary lymph node dissection (ALND)], and the same patient's contralateral arm (control, ie, "other arm").
The mean values for each arm (affected vs control) of the participant group, before (baseline) and 30 minutes after placement of the pneumatic tourniquet were obtained. The difference represents the effect of tourniquet placement. The outcome is reported as the overall mean difference in hand volume from baseline to 30 minutes after tourniquet placement for the ALND arm (affected arm) and the contralateral arm (control arm), with standard deviation.
12 patients only.
30 minutes after tourniquet use
Secondary Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs Hand volume, as an indicator of limb edema / fluid accumulation, was determined with an aqueous volumeter 30 minutes after an arm tourniquet was placed and the arm held in sling and elevated arm positions. Measurements were taken for the affected arm [ie, after axillary lymph node dissection (ALND)], and the same patient's contralateral arm (control, ie, "other arm"). Measurements were compared to the participant's contralateral control ("the other arm") in the same positions. The difference represents to effect of ALND on hand volume. The outcome is reported as the absolute change in mean hand volume between the affected and control arms, a number without dispersion. 30 minutes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02664883 - Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer
Completed NCT05611281 - GS3-007a Oral Solution in Healthy Subjects Phase 1
Completed NCT03457480 - Text Messages in Preventing Tobacco Use in Young Adults N/A
Completed NCT05358756 - A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers Phase 1
Completed NCT06037395 - Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects Phase 1
Active, not recruiting NCT04032106 - HPV Vaccine Intervention for Young Sexual Minority Men N/A
Completed NCT04062955 - Effects of Alternative Healthy Eating Index-Based Diet on Inflammatory Markers and Breast Density in Healthy Participants N/A
Recruiting NCT03897270 - Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects N/A
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT02960100 - mHealth Intervention in Increasing HPV Vaccinations in College Students N/A
Completed NCT03698318 - Pharmacokinetics Assessing Bioavailability of Gingerols and Shogaols of Five Ginger Extracts N/A
Completed NCT05497635 - A Study of STSA-1002 in Healthy Subjects Phase 1
Active, not recruiting NCT03303846 - Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients N/A
Terminated NCT05559125 - A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects Phase 1
Recruiting NCT05117385 - The Effect of the Consumption of 4 Botanical Extracts on Immunity in Healthy Adults (B-4-Immune) N/A
Active, not recruiting NCT05660720 - Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects Phase 1
Recruiting NCT03188848 - Dose Escalating Study of BPI-3016 in Healthy Subjects Phase 1
Completed NCT01908920 - Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects N/A
Active, not recruiting NCT03491176 - Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer N/A
Completed NCT03963323 - Glucosamine and Chondroitin in Gut in Preventing People From Inflammation Phase 1