Walking Affecting Immunology and Quality of Life of Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Walking exercise
No walking exercise
Sponsored by

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Immunology
Eligibility Criteria
Inclusion Criteria:
- Stage I-II breast cancer
- Have undergone ablative surgery
- Going to receive chemotherapy
Exclusion Criteria:
- Difficulty walking
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Walking Exercise
No Intervention
Arm Description
For the exercise group, subjects were asked to follow a simple walking regimen. Walk normally with stable and comfortable stride rates during their exercise. The duration and frequency was initiated at a 30-minute or more daily exercise at least five days per week and gradually increased to a maximum of 60 minutes within subject's comfort zone.
No exercise required
Outcomes
Primary Outcome Measures
CD3, CD4, CD8 counts
CD3, CD4, CD8 counts during the chemotherapy periods
Quality of life measured by short-form36
Quality of life measured by short-form 36
Secondary Outcome Measures
Full Information
NCT ID
NCT02581956
First Posted
October 19, 2015
Last Updated
October 20, 2015
Sponsor
Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT02581956
Brief Title
Walking Affecting Immunology and Quality of Life of Breast Cancer Patients
Official Title
Walking Affecting Immunology and Quality of Life of Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
4. Oversight
5. Study Description
Brief Summary
Breast cancer is the leading cancer in women worldwide. The incidence of breast cancer is increasing probably due to the prolonged life expectancy and a variety of environmental factors. Fortunately, breast cancer outcome and survival are improving due to early detection and new treatment modalities. After making first strides against breast cancer, i.e. undergoing ablation surgery, most breast cancer survivors still have to go through a series of chemotherapy, which could prolong their survival but almost inevitably downgrade their quality of life due to grueling side effects, such as lack of energy and vulnerability to infection. Numerous medical interventions have been tried by healthcare providers to alleviate these side effects, but some of them are expensive and therefore become another burden for the cancer-afflicted patients. Previous studies have already indicated that exercise generated long-term benefits to breast cancer survivors, including improved physical functions, elevated maximal oxygen intake, decreases in lethargic symptom, increase in both immune function and quality of life. Among a variety of exercises, walking is the least costly, easy-to-follow type. Through a simple, predesigned walking regimen, the investigators expected that the breast cancer patients undergoing chemotherapy could cost-effectively reap some benefit either physically or psychologically.
Cluster of differentiation 3 (CD3+), presenting at all stages of T-cell development, is a useful maker to identify T-cells. (Cluster of differentiation 4)CD4+ T cells, also known as T helper cells, play an assistant role in the immunologic process, such as maturation of B cells, activations of macrophages or cytotoxic T cells. Cluster of differentiation 8 (CD8+) T cells, known as cytotoxic T cells, responsible for destroying virus-infected cells and tumor cells. Generally, the counts of CD3+ T cells, CD4+ T cells and CD8+ T cells could be a reflection of immune system health. Short-Form 36(SF-36), a patient-reported survey, is a widely adopted tool to evaluate patient's individual health status. By means of serial blood sample collections and the delivery of SF-36 survey, this study aimed to objectively and quantitatively evaluate the effects of aerobic walking on the breast cancer patients undergoing chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Immunology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walking Exercise
Arm Type
Experimental
Arm Description
For the exercise group, subjects were asked to follow a simple walking regimen. Walk normally with stable and comfortable stride rates during their exercise. The duration and frequency was initiated at a 30-minute or more daily exercise at least five days per week and gradually increased to a maximum of 60 minutes within subject's comfort zone.
Arm Title
No Intervention
Arm Type
Placebo Comparator
Arm Description
No exercise required
Intervention Type
Behavioral
Intervention Name(s)
Walking exercise
Intervention Description
Walk normally with the duration and frequency at a 30- minute or more daily at least five days per week and gradually increased to a maximum of 60 minutes daily.
Intervention Type
Behavioral
Intervention Name(s)
No walking exercise
Intervention Description
no exercise
Primary Outcome Measure Information:
Title
CD3, CD4, CD8 counts
Description
CD3, CD4, CD8 counts during the chemotherapy periods
Time Frame
through study completion, an average of 6 months
Title
Quality of life measured by short-form36
Description
Quality of life measured by short-form 36
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage I-II breast cancer
Have undergone ablative surgery
Going to receive chemotherapy
Exclusion Criteria:
Difficulty walking
12. IPD Sharing Statement
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Walking Affecting Immunology and Quality of Life of Breast Cancer Patients
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