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CompletedNCT03945838Updated May 10, 2019

Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema

An observational study in Lymphedema Arm and Lymphedema; Surgical, sponsored by Ege University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-05-10.

Sponsored by Ege University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
74
Ages
18 Years to 70 Years
Sex
Female
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Study summary

This study aims to find whether complete decongestive therapy used in breast cancer-related lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy of the therapy itself. 74 patients with breast cancer related lymphedema were included in this study. Patients were taken their demographic and clinical history and were evaluated with measurements of extremity volumes and hand grip strengths using a hand dynamometer before and after the complete decongestive therapy. Data were then assessed using relevant statistical methods.

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Conditions studied

  • Lymphedema Arm
  • Lymphedema; Surgical

Keywords

  • Lymphedema
  • Hand grip strength
  • Breast cancer related lymphedema
  • Complete decongestion therapy
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In context

Lymphedema

561 studies on the registry are indexed under Lymphedema; 136 are open to participants now.

This study's enrollment of 74 is below the median of 106 across 144 observational studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients between 18-70 years old with a history of mastectomy or breast conserving surgery and lymphedema

  • Having a certain diagnosis of lymphedema

Inclusion criteria

  • Having had mastectomy or breast conserving surgery
  • Having a certain diagnosis of lymphedema with a difference in arm circumferences more than 1 cm

Exclusion criteria

Exclusion Criteria:

  • The subjects with active infection or cancer with metastases, the ones who didn't accept the complete decongestive therapy, patients with vascular disease, rheumatic disease, upper limb deformity, any upper limb surgery history, bilateral lymphedema or a history of transplantation were excluded
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
74 participants (actual)
Patient registry
No

Groups and cohorts

  • Breast cancer related lymphedema

    All patients were included in the complete decongestive therapy programme. This therapy includes patient education, skin care, exercises, manual lymphatic drainage (self), and compression bandage therapy.

    Other: Complete Decongestion Therapy

Interventions

  • OtherComplete Decongestion Therapy

    It is given in two phases. First phase includes intensive therapy which aims to reduce the volume of the extremity. Second phase aims to preserve these reductions of volume. All patients were prescribed lymphedema specific exercises and were advised to walk (for 30 minutes everyday) daywhile taking complete decongestive therapy. They were specifically informed that exercise does not aggravate the severity of their lymphedema. Short stretch bandages were applied to the patients with self manual lymphatic drainage. Intensive phase was given 5 days a week, and short stretch bandages applied for 23 hours a day with 1 hour interval. To increase the local pressure on the areas required, foams were added. Patients were screened with arm circumferential measurements once a week. After gaining a plateau in the volumes, patients were prescribed compression garments.

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What researchers measure

Primary outcomes

  1. Hand grip strength

    Hand grip strength: Hand grip strength was measured using JAMAR® hand dynamometer. It has been used to assess hand grip strength in many studies over half a century. Patients were asked to sit down with shoulder adducted, elbow flexed (90°) and forearm in the neutral position. Mean of the 3 measurements taken with 1 minute apart from each other was recorded. Patients' measurements were taken for both affected and unaffected arm, and recorded as kgf.

    Time frame: 3 weeks

  2. Extremity volume

    Volume measurements were taken using ulnar styloid process as a index point, and circumferential measurements were taken with 5 cm spaces from distal to the proximal. Using a computer programme (Limb Volumes Professional version 5.0), the total volume of the arm was calculated and recorded before and after the treatment for both arms. All patients' measurements were taken by the same researcher.

    Time frame: 3 weeks

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Study locations

1 site
  • Ege university school of medicine
    Izmir, 35100, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03945838
Lead sponsor
Ege University
Responsible party
Göksel Tanıgör M.D. (Researcher in Ege University School of Medicine, Ege University) — Principal investigator
First posted
May 10, 2019
Start date
Apr 4, 2017
Primary completion
Apr 24, 2018
Completion
Apr 24, 2018
Last update
May 10, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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