RESISTANCE VERSUS AEROBIC EXERCISES ON Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Resistance Versus Aerobic Exercises On Cancer Related Fatigue And Immunity In Breast Cancer Patients Undergoing Adjuvant Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04656457
• Other study ID #: P.T.REC/012/002968
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: December 2020
• Source: Cairo University
• Contact: Lamiaa sa tolba, ASS.lecturer
• Phone: 01007215433
• Email: lamiaa.said[@]pua.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate which is more effective resistance or aerobic exercises on cancer related fatigue and immunity in breast cancer patients undergoing adjuvant chemotherapy.

Description:

The problem of cancer related fatigue and decreased immunity, as a result of treatment with adjuvant chemotherapy in breast cancer patients is not well known.

Fatigue and decreased immunity have a negative impact on work, social relationships, mood, and daily activities and cause significant impairment in overall quality of life, Furthermore the need of this study is developed from the lack of information in the published studies about the effect of the treatment with chemotherapy among breast cancer patients on inducing fatigue and decreasing immunity and the effect of resistance and aerobic exercises on improving these changes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

-

The subject selection will be according to the following criteria:

1. Age range from 30-60 years.

2. Females post mastectomy only will participate in the study.

3. All patients undergoing adjuvant chemotherapy and have cancer related fatigue and decreased immunity.

4. All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

• The potential participants will be excluded if they meet one of the following criteria:

1. Age more than 60 years or less than 30 years.

2. Another concurrent malignant disease.

3. Subjects suffering from any condition for which resistance or aerobic exercises contraindicated as metastasis, sever osteoporosis and cardiac diseases.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Treadmill
Treadmill is not used to harness power, but as exercise machines for running or walking in one place. Rather than the user powering the mill, the machine provides a moving platform with a wide conveyor belt driven by an electric motor or a flywheel. The belt moves to the rear, requiring the user to walk or run at a speed matching that of the belt. The rate at which the belt moves is the rate of walking or running. Thus, the speed of running may be controlled and measured

Other:
• resisted exercises
Resistance exercises will be involved in this technique are for upper and lower limb (Exercise program including shoulder flexion, abduction and horizontal adduction, elbow extension and flexion, calf raise, leg extension and squatting)

Locations

Country	Name	City	State
Egypt	Medical research institute	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue assessment scale	The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases	The evaluation will be conducted during before the cycles
Primary	Fatigue assessment scale	The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases	The evaluation will be conducted during one and half month
Primary	Fatigue assessment scale	The Fatigue Assessment Scale (FAS) is quick and easy to complete for patients, and not time consuming. It is also helpful for physicians and other health care workers in the follow-up of their patients. The FAS has proven to be a valid questionnaire to assess fatigue in cancer patients, but also in many other patients with chronic diseases	The evaluation will be conducted three months later
Primary	Hemoglobin level test for fatigue assessment	Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen	he evaluation will be conducted before the cycles
Primary	Hemoglobin level test for fatigue assessment	Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen	he evaluation will be conducted during one and half month
Primary	Hemoglobin level test for fatigue assessment	Hemoglobin levels are measured by a blood test. Hemoglobin, or Hb, is usually expressed in grams per deciliter (g/dL) of blood. A low level of hemoglobin in the blood relates directly to a low level of oxygen	he evaluation will be conducted three months later
Primary	White blood cells count test for immunity assessment	White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system	he evaluation will be conducted before the cycles
Primary	White blood cells count test for immunity assessment	White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system	he evaluation will be conducted during one and half month
Primary	White blood cells count test for immunity assessment	White blood cells (also called leukocytes and abbreviated as WBCs) are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from multipotent cells in the bone marrow known as hematopoietic stem cells. Leukocytes are found throughout the body, including the blood and lymphatic system	he evaluation will be conducted three months later