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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
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Immunology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Stage I-II breast cancer
  2. Have undergone ablative surgery
  3. 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

    First Posted
    October 19, 2015
    Last Updated
    October 20, 2015
    Sponsor
    Kaohsiung Veterans General Hospital.
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    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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