Aerobic Training for Breast Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
Breast Cancer+1 More
Aerobic Training - Behavioral
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer is safe and effective.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Aerobic Training will improve 1 primary outcome and 5 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing.

Week 24
Depression scale during and after Chemotherapy
Physical activity recall during and after Chemotherapy
Quality of Life measured by questionnaire during and after Chemotherapy
Skeletal Muscle Function
Sleeping patterns as measured by questionnaire during and after Chemotherapy
Month 6
Change in VO2 peak (functional capacity)

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

No Control Group
General Physical Activity Group

This trial requires 144 total participants across 4 different treatment groups

This trial involves 4 different treatments. Aerobic Training is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

General Physical Activity GroupPatients will receive a home-based, general physical activity program. Specifically, all patients assigned to general physical activity will receive an initial, consultation with a staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of their normal daily activity. Patients can be provided with a fitness tracker (e.g. FitBit) to evaluate exercise duration and intensity. Patients may also be provided with an exercise log to record type, duration, and average heart rate during sessions. The exercise log is provided as a guidance tool and may be, although is not required to be, returned to study staff. Staff exercise physiologists will contact patients to check progress, and answer questions.
Aerobic Training After Chemotherapy
Behavioral
The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training at an intensity 55% to 100% of the individually determined exercise capacity (VO2peak), after the completion of chemotherapy. VO2peak will be determined by the CPET performed at midpoint, or pre-surgery for neoadjuvant patients. For patients receiving adjuvant therapy, (except those who have additional surgery after chemotherapy), the aerobic training intervention must begin within 2 weeks of the patient's midpoint CPET. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, the aerobic training intervention will begin within approximately 6 weeks of surgery, per the discretion of the treating physician. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
Continuous Aerobic Training
Behavioral
The ultimate goal is for participants to complete 3 exercise sessions week of non-linear aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), during and after chemotherapy. For patients receiving adjuvant therapy (except those who have additional surgery after chemotherapy), VO2peak will be determined by the CPETs performed at baseline and midpoint. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, VO2peak will be determined by the CPETs or at baseline, pre- surgery, and post-surgery. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
Aerobic Training During Chemotherapy
Behavioral
The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training an intensity of at 55% to 100% of the individually determined exercise capacity VO2peak), concurrent with chemotherapy. VO2peak will be determined by the CPET performed at baseline. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Training
2020
N/A
~770

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during chemotherapy 3-6 months depending on treatment recommendations
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly during chemotherapy 3-6 months depending on treatment recommendations for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, patients often have difficulty adhering to their prescribed treatment regimens show original
is associated with a lower risk of all-cause mortality Exercising less than 150 minutes per week is linked to a lower risk of mortality from any cause. show original
If you are a woman of child-bearing potential, you must not be pregnant or planning to become pregnant during the study. show original
Women must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy if they are under 50 years old. show original
The text explains that when someone achieves a plateau in oxygen consumption, their power output will also increase. show original
The study looked at people aged between 21 and 80 years old. show original
The patient was diagnosed with early-stage operable breast cancer based on a MSK histology. show original
Female
A patient's ECOG status is either 0 or 1 show original
The participant must be able to complete a baseline CPET without any abnormal ECG readings or other issues that would prevent them from safely participating in the study. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can breast cancer be cured?

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Findings from a recent study suggest that while breast cancer has a cure rate of 30-50%, a substantial proportion of patients will still have some disease at the time of their deaths. Findings from a recent study of the current study may have important implications on the future use of chemotherapy in breast cancer treatment.

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What causes breast cancer?

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Both genetic and environmentally caused risks are likely to be involved. The breast cancer rate for whites is higher than for other racial groups in the US (see epidemiology).

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What is breast cancer?

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Breast cancer, the leading cause of cancer related deaths among women and women’s most common cancer, occurs in both sexes. It can occur in any region of the breast, can be detected during an exam, and may be felt through a finger poke test. Breast cancer is more common in postmenopausal women who have not had a baby. In most cases, breast cancer is not a single form. Breast cancer is a disease that varies from one person to the next. Treatment depends on what type of cancer the person is diagnosed with and how advanced the disease is and the person's general health. The five-year survival rate was greater than 99% and decreased steadily from 1996 to 2015.

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How many people get breast cancer a year in the United States?

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The American Cancer Society estimates that 1,095,600 new cases of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) will be diagnosed in 2020, making it the second most prevalent cancer in men.

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What are common treatments for breast cancer?

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Treatment for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) depends on the stage of the disease, the type of cancer, and how aggressive it is. Breast cancers may receive surgery (biopsies of the lump(s)), radiation, chemotherapy, hormonal therapy, targeted therapy, or a combination. Most tumors respond well to surgery and treatment with adjuvant radiation, medication, or other therapy. Surgical removal of tumors from the local lymph nodes is needed to get cancer in all stage 4 to stage 6 breast cancer patients. A biopsy of the lump and/or a tissue sample is also done to rule out any other cancer that may be present inside the breast.

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What are the signs of breast cancer?

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Signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can include a lump or lumpiness in the breast due to cancer. The lump may be warm or tender to the touch. Signs can also include pain or bleeding in the breast or nipple. A hard breast can feel like a stone or bump. Other signs include the following: nipple discharge or nipple irritation or redness, skin changes, nipple swelling, and changes in the size or shape of the breast. Many women only learn of their cancer or that they have it after the tumor is advanced. The diagnosis of cancer in a postmenopausal woman is made because the symptoms last beyond two years after the menopause or the body starts producing less estrogen. The symptoms can be confused with other health conditions.

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What are the chances of developing breast cancer?

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Even though both men and women can develop breast cancer, it appears that the vast majority of breast cancers are found in women over 40 years.

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What are the latest developments in aerobic training for therapeutic use?

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We found that aerobic training can be used as a therapeutic modality for the reduction of blood pressure and glucose, and as adjuvant therapy for the control of other health risks associated with obesity (increased body fat percentage and risk factors in the cardiovascular risk factor (CVRF) concept). In this way, aerobic training is useful for the management of CVRF and its associated diseases.

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What is the average age someone gets breast cancer?

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These data are important for the design and interpretation of large clinical studies in which the incidence of breast cancer is the outcome of interest.

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How serious can breast cancer be?

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The seriousness of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can't be underestimated. The risk is far higher in case the cancer is in early stages. The higher the stage of cancer, the lower the probability of a full recovery from the disease. In case of late stage or metastatic breast cancer, the patient is unlikely to achieve a full resolution of the disease. When a cancer with metastatic stage is diagnosed, only a few days are left. In these cases, the overall average survival from cancer is approximately 2 months. However, in case of a late stage cancer, the survival rate rises to approximately 6 months. The treatment in case of metastatic cancer is to focus on suppressing metastasis through different methods.

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What is the survival rate for breast cancer?

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In India, only 2 out of 3 women are diagnosed with early stage breast cancer which is important for improving the survival rate because it is a key factor in predicting survival for patients. Survival rate for metastatic breast cancer is still poor, even though there is significant improvement in the management in recent years. Survival rate for small cell types of non-metastatic breast cancer is poor except in the cases of hormone naïve breast cancer.

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Have there been other clinical trials involving aerobic training?

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Data from a recent study shows that aerobic training does not have beneficial effects in the treatment of breast cancer, as other studies have found. Further studies are required to determine whether alternative training systems would have a more favourable outcome and would therefore be preferable for breast cancer patients.

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