Breast CancerNCT02676531
Walking Meditation Exercise in Breast Cancer Patients
A study testing Exercise in people with Breast Cancer, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study is to evaluate the effects of Walking Meditation on vascular function in breast cancer patients receiving Anthracyclines chemotherapy Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2015to Dec 2017
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria included stage 1-2 of Breast cancer patients after an operation with or without Hormone Receptor Positive and HER2 Positive.
- 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.
Who cannot join
- 1. Participants will be excluded if they dropped out or completed less than 80% of the training schedule.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Sports Science, Chulalongkorn University
Pathum Wan, Bangkok, 10330
About this study
Official title: Effects of Walking Meditation on Vascular Function in Breast Cancer Patients Receiving Anthracyclines Chemotherapy
This study is to evaluate the effects of Walking Meditation on vascular function in breast cancer patients receiving Anthracyclines chemotherapy
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Exercise
- Keywords
- Walking Meditation, Vascular Function, Flow-mediated dilatation, Breast Cancer Patients, Anthracyclines Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Walking meditation exercise program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise |
| No Walking meditation | No intervention | keep regular activities, sedentary life style. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, up to 12 weeks
Secondary outcomes (8)
Change from baseline in Intima-Media Thickness: IMT
Intima-Media Thickness will be assessed with the ultrasound equipment (CX50, Philips, USA).
Measured: baseline, up to 12 weeks
Change from baseline in Peripheral arterial stiffness
Pulse wave velocity (brachial-ankle PWV) measurement will be assessed by using Omron Colin VP1000.
Measured: baseline, up to 12 weeks
Change from baseline in venous blood flow
Venous blood flow will be assessed with the ultrasound equipment (CX50, Philips, USA). The Basilic vain will be illustrated in the longitudinal plane. Venous blood flow will be measured at resting and squeezing hand for 3 minutes and 5 minutes of recovery. Venous blood flow will be calculated from the formula CSA x V when CSA is the cross sectional area of Basilic vain, V is the velocity in vessel.
Measured: baseline, up to 12 weeks
Change from baseline in blood chemistry
- Nitric oxide (NO) will be measured in serum samples with the commercial assay kit.
- Malondialdehyde (MDA) will be determined in plasma samples using the High Performance Liquid Chromatography (HPLC).
- Interleukin-6 (IL-6) will be measured in serum samples with the ELISA kit.
- hs-CRP will be measured in serum samples with the ELISA kit.
Measured: baseline, up to 12 weeks
Change from baseline in Maximal oxygen consumption
Maximal oxygen consumption (VO2max) will be assessed by Bruce Ramp Protocol for treadmill test with Stationary Gas Analyzer (Vmax™ Encore 29 system, Yorba Linda, CA).
Measured: baseline, up to 12 weeks
Change from baseline in Cardiac output and stroke volume
Cardiac output and stroke volume will be measured by using Physioflow (PF07 enduro).
Measured: baseline, up to 12 weeks
Change from baseline in Body Mass Index (BMI)
Body Mass Index (BMI) will be measured using Body Composition Analyzer (Model ioi 353, Jawon Medical Co. Ltd., Korea). BMI will be calculated by dividing weight in kilograms by height in metres squared.
Unit of BMI is kg/m2.
Measured: baseline, up to 12 weeks
Change from baseline in stress indicators
Serum cortisol will be measured with cortisol kit.
Measured: baseline, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Dr.Daroonwan Suksom, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676531
- Sponsor's protocol ID
- SPSC-5
- Status last verified
- Apr 2018
- First submitted
- 17 Jan 2016
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 37036793
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Walking Meditation on Vascular Function in Breast Cancer Patients Receiving Anthracyclines Chemotherapy
- ClinicalTrials.gov ID
- NCT02676531
- Acronym / sponsor ID
- SPSC-5
- Conditions
- Breast Cancer
- Keywords
- Walking Meditation, Vascular Function, Flow-mediated dilatation, Breast Cancer Patients, Anthracyclines Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the effects of Walking Meditation on vascular function in breast cancer patients receiving Anthracyclines chemotherapy
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking Meditation | Experimental | Other: ExerciseWalking 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. |
| No Walking meditation | No intervention | –keep regular activities, sedentary life style. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The inclusion criteria included stage 1-2 of Breast cancer patients after an operation with or without Hormone Receptor Positive and HER2 Positive.
- 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.
Key exclusion criteria (1 listed)
- 1. Participants will be excluded if they dropped out or completed less than 80% of the training schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseWalking meditation exercise program | Other | Walking Meditation |
Primary outcome
Change from baseline in vascular reactivity
Time frame: baseline, up to 12 weeks
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.
8 secondary outcomes
Change from baseline in Intima-Media Thickness: IMT
Time frame: baseline, up to 12 weeks
Change from baseline in Peripheral arterial stiffness
Time frame: baseline, up to 12 weeks
Change from baseline in venous blood flow
Time frame: baseline, up to 12 weeks
Change from baseline in blood chemistry
Time frame: baseline, up to 12 weeks
Change from baseline in Maximal oxygen consumption
Time frame: baseline, up to 12 weeks
Change from baseline in Cardiac output and stroke volume
Time frame: baseline, up to 12 weeks
Change from baseline in Body Mass Index (BMI)
Time frame: baseline, up to 12 weeks
Change from baseline in stress indicators
Time frame: baseline, up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Derived from this study: PubMed 37036793Siripanya 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Breast Cancer, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. 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 10 Apr 2018. 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 Thailand. 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?
Change from baseline in vascular reactivity (time frame: baseline, up to 12 weeks). 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 NCT02676531, 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 10 Apr 2018.