Walking Affecting Immunology and Quality of Life of Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Walking Affecting Immunology and Quality of Life of Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581956
• Other study ID #: VGHKS96-CT4-17
• Status: Completed
• Phase: N/A
• First received: October 19, 2015
• Last updated: October 20, 2015
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: October 2015
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Stage I-II breast cancer

2. Have undergone ablative surgery

3. Going to receive chemotherapy

Exclusion Criteria:

• Difficulty walking

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Walking exercise
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.
• No walking exercise
no exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD3, CD4, CD8 counts	CD3, CD4, CD8 counts during the chemotherapy periods	through study completion, an average of 6 months	No
Primary	Quality of life measured by short-form36	Quality of life measured by short-form 36	through study completion, an average of 6 months	No