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Breast CancerNCT03262831

Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer

A study testing Yoga, Blood draw and FACT-G questionnaire in people with Breast Cancer and Cancer of Breast, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators hypothesize that a personalized yoga program with mindful movement implemented during breast cancer therapy will benefit women in multiple ways. The investigators predict that women participating in the program will experience less weight gain and fatigue and will have an improved quality of life… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Cancer of Breast
What is being tested?
Yoga, Blood draw and FACT-G questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
10 Jan 2018to 26 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Eligibility Critera:

  • Age ≥ 18.
  • Female.
  • Newly diagnosed with Stage I-III breast cancer.
  • Scheduled to undergo neoadjuvant or adjuvant chemotherapy or neoadjuvant endocrine therapy.
  • Not currently regularly practicing yoga (defined as at least once a month).
  • Able to read and understand English
  • Able to understand and willing to sign an IRB-approved written informed consent document

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: The Role of Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer

The investigators hypothesize that a personalized yoga program with mindful movement implemented during breast cancer therapy will benefit women in multiple ways. The investigators predict that women participating in the program will experience less weight gain and fatigue and will have an improved quality of life compared to women not participating in the program. The investigators predict that this will be associated with decreased markers of inflammation. The investigators will also evaluate whether there is improved pathologic response rate compared to historical controls. This study will provide pilot data for a larger randomized controlled trial assessing whether program can provide long-term improvement in quality of life, weight maintenance, and the serum and tumor changes correlating with a reduced risk of recurrence and mortality.

Being tested
Yoga, Blood draw, FACT-G questionnaire, Weight measurement, Recent Physical Activity Questionnaire
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YogaOther

    The yoga practice, Gentle Hatha and Restorative Yoga, will be based on protocols that have been found to decease fatigue and weight gain by helping the participant gain insight in recognizing stress responses and ways to relax

  • Blood drawProcedure or surgery

    • Baseline and end of treatment
    • To evaluate change in inflammatory markers (CRP, IL-6, and TNF)

  • FACT-G questionnaireBehavioural

    • 7 statements that other people with breast cancer have said are important, the patient is to circle or mark one number per line to indicate the response as it applies in the last 7 days
    • Answers range from 0=not at all to 4=very much

  • Weight measurementProcedure or surgery

    -Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment

  • Recent Physical Activity QuestionnaireBehavioural

    Also called RPAQ

    -To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.

  • NHANES Food QuestionnaireBehavioural

    -To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.

Study groups in NCT03262831
Study groupRoleWhat they receive
Arm 1: YogaExperimental* Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga * Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation. * The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel * During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.
Receives: Other: Yoga; Procedure: Blood draw; Behavioral: FACT-G questionnaire; Procedure: Weight measurement; Behavioral: Recent Physical Activity Questionnaire; Behavioral: NHANES Food Questionnaire
Arm 2: No YogaActive comparator-Patients in this arm will not receive a personalized yoga plan
Receives: Procedure: Blood draw; Behavioral: FACT-G questionnaire; Procedure: Weight measurement; Behavioral: Recent Physical Activity Questionnaire; Behavioral: NHANES Food Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled

    -Feasibility is defined as the ability to enroll 60% of eligible patients

    Measured: Completion of study enrollment (estimated to be 6 months)

  2. Feasibility of conducting a larger randomized trial using yoga and mindful movement

    -Feasibility is defined as the ability to have an 80% completion rate of the intervention

    Measured: Completion of study enrollment (estimated to be 6 months)

  3. Efficacy of yoga exercise as measured by weight change from baseline to completion

    Measured: Completion of treatment (estimated to be 6 months)

Secondary outcomes (4)

  1. Effect of yoga exercise as measured by rate of pathologic response (partial and complete) (neoadjuvant subset only)

    Measured: Completion of treatment (estimated to be 6 months)

  2. Effect of yoga exercise as measured by inflammatory markers

    Measured: Completion of treatment (estimated to be 6 months)

  3. Effect of yoga exercise as measured by fatigue index

    -Fatigue index will be measured by FACT-G questionnaire

    Measured: Completion of treatment (estimated to be 6 months)

  4. Effect of yoga exercise as measured by quality of life

    -Quality of life will be measured by FACT-G questionnaire

    Measured: Completion of treatment (estimated to be 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2017
  2. Study start10 Jan 2018
  3. Primary completion26 Jun 2019
  4. Study completion26 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03262831
Sponsor's protocol ID
201708076
Status last verified
Aug 2019
First submitted
23 Aug 2017
Last updated
3 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Greaney SK, Amin N, Prudner BC, Compernolle M, Sandell LJ, Tebb SC, Weilbaecher KN, Abeln P, Luo J, Tao Y, Hirbe AC, Peterson LL. Yoga Therapy During Chemotherapy for Early-Stage and Locally Advanced Breast Cancer. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221137285. doi: 10.1177/15347354221137285.

    PubMed 36412916

Questions about this trial

What is this clinical trial studying?

A study testing Yoga, Blood draw and FACT-G questionnaire in people with Breast Cancer and Cancer of Breast, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled (time frame: Completion of study enrollment (estimated to be 6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03262831, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.

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