NCT05983380

Brief Summary

The purpose of this study is to determine whether the addition of simple hand mobility and grip strengthening exercises to the usual care for upper extremity lymphedema will reduce limb volume and improve the quality of life, hand dexterity, and grip strength for those experiencing breast cancer-related lymphedema. Researchers will compare those receiving the usual treatment to those receiving the usual treatment plus hand mobility and grip strengthening exercises.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

3 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

July 20, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

July 20, 2023

Last Update Submit

April 15, 2024

Conditions

Breast Cancer Lymphedema

Outcome Measures

Primary Outcomes (1)

  • Upper Limb volume

    Circumferential measurements of the upper limb, converted to volumetric measurements with frustrum equation through Epic EMR.

    Day 1, at 4 weeks, at 8 weeks of treatment/completion of study.

Secondary Outcomes (3)

  • Grip Strength

    Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.

  • Nine-Hole Peg Test

    Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.

  • Lymphedema Life Impact Scale

    Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.

Study Arms (2)

Experimental

EXPERIMENTAL

Participants will receive hand mobility and grip strengthening exercises in addition to the usual care for breast cancer-related lymphedema of the upper limb.

Other: Hand Mobility and Grip Strengthening ExercisesOther: Usual Care

Comparison

ACTIVE COMPARATOR

Participants will receive only the usual care for breast cancer-related lymphedema.

Other: Usual Care

Interventions

Hand Mobility and Grip Strengthening ExercisesOTHER

Addition of hand mobility and grip strengthening exercises to the usual care for breast cancer-related lymphedema to assess changes in limb volume, quality of life, and hand function.

Experimental
Usual CareOTHER

Manual lymphatic drainage, compression, exercise, skin hygiene.

ComparisonExperimental

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiologic women due to increased prevalence of breast cancer diagnosis.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biologic women age 18 years or older with a diagnosis of clinical lymphedema of one upper extremity-early (clinical), moderate, or late stage, following treatment for breast cancer within the previous 10 years.

You may not qualify if:

  • Previous treatment for upper limb lymphedema or a prior diagnosis of congestive heart failure or end-stage renal disease due to the impact on edematous limbs and risk of cardiac overload.
  • Women who cannot speak or read English or Spanish sufficiently to complete the Lymphedema Life Impact Scale or understand the consent forms, educational information, and printed exercises will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Presbyterian Healthplex

Albuquerque, New Mexico, 87109, United States

RECRUITING

Presbyterian Southern Outpatient Rehab

Rio Rancho, New Mexico, 87124, United States

RECRUITING

Presbyterian Santa Fe Medical Center

Santa Fe, New Mexico, 87507, United States

RECRUITING

Related Publications (7)

  • Ahmad FB, Anderson RN. The Leading Causes of Death in the US for 2020. JAMA. 2021 May 11;325(18):1829-1830. doi: 10.1001/jama.2021.5469. No abstract available.

    PMID: 33787821BACKGROUND

  • Ahmed RL, Prizment A, Lazovich D, Schmitz KH, Folsom AR. Lymphedema and quality of life in breast cancer survivors: the Iowa Women's Health Study. J Clin Oncol. 2008 Dec 10;26(35):5689-96. doi: 10.1200/JCO.2008.16.4731. Epub 2008 Nov 10.

    PMID: 19001331BACKGROUND

  • Chromy A, Zalud L, Dobsak P, Suskevic I, Mrkvicova V. Limb volume measurements: comparison of accuracy and decisive parameters of the most used present methods. Springerplus. 2015 Nov 19;4:707. doi: 10.1186/s40064-015-1468-7. eCollection 2015.

    PMID: 26618096BACKGROUND

  • Davies C, Levenhagen K, Ryans K, Perdomo M, Gilchrist L. Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guideline From the Academy of Oncologic Physical Therapy of APTA. Phys Ther. 2020 Jul 19;100(7):1163-1179. doi: 10.1093/ptj/pzaa087.

    PMID: 32589208BACKGROUND

  • De Groef A, Van Kampen M, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. Effectiveness of postoperative physical therapy for upper-limb impairments after breast cancer treatment: a systematic review. Arch Phys Med Rehabil. 2015 Jun;96(6):1140-53. doi: 10.1016/j.apmr.2015.01.006. Epub 2015 Jan 13.

    PMID: 25595999BACKGROUND

  • Feys P, Lamers I, Francis G, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):711-720. doi: 10.1177/1352458517690824. Epub 2017 Feb 16.

    PMID: 28206826BACKGROUND

  • Giray E, Akyuz G. Assessment of Family Caregiver Burden and Its Relationships Between Quality of Life, Arm Disability, Grip Strength, and Lymphedema Symptoms in Women with Postmastectomy Lymphedema: A Prospective Cross-Sectional Study. Eur J Breast Health. 2019 Feb 15;15(2):111-118. doi: 10.5152/ejbh.2019.4385. eCollection 2019 Apr.

    PMID: 31001613BACKGROUND

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

LymphedemaLymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elisabeth Wise, DPT

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Wise, DPT

CONTACT

505-772-1770EWise@phs.org

Tiffany Ryan, MOT/R

CONTACT

505-772-1775TRyan3@phs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be masked regarding whether they are assigned to the intervention or comparison group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups will be compared, with treatment occurring at the same time. One group will receive the experimental exercises plus the usual treatment, the comparison group will only receive the usual treatment for breast cancer-related lymphedema.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator, Physical Therapist

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 9, 2023

Study Start

October 1, 2023

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

No plan to share IPD with other researchers.

Locations

US(3)