NCT02923037

Brief Summary

This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast cancer survivors with lymphedema as they directly support lymph transport (postures, breathing, relaxation) and emotional well-being (relaxation, meditation).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

September 29, 2016

Last Update Submit

March 22, 2019

Conditions

Breast CarcinomaLymphedema

Outcome Measures

Primary Outcomes (2)

  • Pose Modifications

    number of poses requiring modifications as indicated in the modification form

    Up to 8 weeks

  • Assess safety

    Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0

    Up to 8 weeks

Study Arms (1)

Supportive Care (Yoga)

EXPERIMENTAL

Patients undergo an initial yoga evaluation for 60 minutes. Patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes 3 times a week for 4 weeks, and twice a week for an additional 4 weeks. Patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks. They will have tape measurement of arms and ldex measurement of arms. Quality-of-Life Assessment will also be made.

Procedure: YogaOther: tape measurement of armOther: Quality-of-Life AssessmentOther: ldex measurement of arms

Interventions

YogaPROCEDURE

Complete guided and home yoga sessions

Supportive Care (Yoga)
tape measurement of armOTHER

Ancillary studies

Supportive Care (Yoga)
Quality-of-Life AssessmentOTHER

Ancillary studies

Supportive Care (Yoga)
ldex measurement of armsOTHER
Supportive Care (Yoga)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lymphedema Group:
  • Lymphedema, symptomatic of stage II or III based upon screening responses; or L-Dex reading of ≥ 7 at initial visit,
  • \> 3 months (mths) post-breast cancer treatment
  • No active cancer
  • Has compression sleeve
  • Ability to understand English in order to complete questionnaires
  • Willing to do guided and home yoga practice
  • Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
  • Medical clearance
  • Reliable transportation to the study site
  • No Lymphedema Group:
  • No known lymphedema or intermittent swelling, not symptomatic of Stage II or III lymphedema (L-Dex ≥ 7)
  • \>3 months post- breast cancer treatment
  • No active cancer
  • Ability to understand English in order to complete questionnaires
  • +4 more criteria

You may not qualify if:

  • Active cancer
  • Undergoing radiation therapy or chemotherapy
  • Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, compromised mental status)
  • Active yoga practice \< 3 months
  • Currently undergoing phase I complete decongestive therapy (CDT)
  • Inability to complete study forms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University School of Nursing

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Sheila Ridner, PhD, RN

    Vanderbilt University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 4, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2018

Study Completion

March 1, 2019

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

US(1)