NCT02676531

Brief Summary

This study is to evaluate the effects of Walking Meditation on vascular function in breast cancer patients receiving Anthracyclines chemotherapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

January 17, 2016

Last Update Submit

April 9, 2018

Conditions

Breast Cancer

Keywords

Walking MeditationVascular FunctionFlow-mediated dilatationBreast Cancer PatientsAnthracyclines Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in vascular reactivity

    Vascular reactivity or brachial artery flow-mediated dilatation (FMD) will be assessed with the ultrasound equipment (CX50, Philips, USA), using the blood occlusion technique on the forearm. The brachial artery will be illustrated above the antecubital fossa in the longitudinal plane. Brachial FMD will be measured at resting and the cuff placed around the forearm will be inflated to 50 mmHg above systolic blood pressure for 5 minutes and then deflated for 5 minutes of recovery. FMD will be calculated from the formula FMD= (D2-D1) x100/D1 when D1 is the brachial artery diameter at baseline, D2 is the maximal post-occlusion brachial artery diameter.

    baseline, up to 12 weeks

Secondary Outcomes (8)

  • Change from baseline in Intima-Media Thickness: IMT

    baseline, up to 12 weeks

  • Change from baseline in Peripheral arterial stiffness

    baseline, up to 12 weeks

  • Change from baseline in venous blood flow

    baseline, up to 12 weeks

  • Change from baseline in blood chemistry

    baseline, up to 12 weeks

  • Change from baseline in Maximal oxygen consumption

    baseline, up to 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Walking Meditation

EXPERIMENTAL

Walking Meditation program will be based on aerobic walking exercise combined with Buddhist meditation. The subjects will perform walking while listening to the sound "Budd" and "Dha" and squeeze rubber balls according to the sound in order to practice mindfulness while walking. In phase 1 (week 1-6), Walking Meditation will be conducted at initial moderate intensity (41-50% heart rate reserve) 3 sets, 10 minutes per set and rest 3 minutes between set In phase 2 (week 7-12), the training intensity will be increased to ultimate moderate intensity (51-60% heart rate reserve) 3 sets, 15 minutes per set and rest 3 minutes between set. In both phases of the training, the frequency of Walking Meditation training is three times a week.

Other: Exercise

No Walking meditation

NO INTERVENTION

keep regular activities, sedentary life style.

Interventions

ExerciseOTHER

Walking meditation exercise program

Walking Meditation

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants will be planned to use Anthracyclines chemotherapy in next 1 month by oncologist.
  • All participants did not participate in any exercise training in the past 6 months
  • All participants are free from acute or chronic renal failure, Heart Failure, Myasthenia gravis, pregnancy and history of smoke.

You may not qualify if:

  • \. Participants will be excluded if they dropped out or completed less than 80% of the training schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Siripanya S, Parinyanitikul N, Tanaka H, Suksom D. Home-Based Buddhist Walking Meditation Mitigates Cardiotoxicity of Anthracycline Chemotherapy in Breast Cancer Patients: A Randomized Controlled Trial. J Integr Complement Med. 2023 Sep;29(9):562-573. doi: 10.1089/jicm.2022.0778. Epub 2023 Apr 10.

    PMID: 37036793DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of sports science

Study Record Dates

First Submitted

January 17, 2016

First Posted

February 8, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

April 10, 2018

Record last verified: 2018-04

Locations

TH(1)