Exercise Intervention for Anatomic Stage II Breast Cancer AJCC v8

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Anatomic Stage II Breast Cancer AJCC v8+20 More
Exercise Intervention - Other
Eligibility
65+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether exercise during chemotherapy is feasible for older women with breast cancer.

See full description

Eligible Conditions

  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage 1 Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage 1 Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage 2 Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Exercise Intervention will improve 3 primary outcomes and 6 secondary outcomes in patients with Anatomic Stage II Breast Cancer AJCC v8. Measurement will happen over the course of Baseline up to 1 month after chemotherapy.

Month 1
Geriatric assessment
Outcome Expectations for Exercise (OEE) Scale Questionnaires
Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM) questionnaires
Quality of life questionnaires
Short Physical Performance Battery (SPPB)
Month 1
Adherence
Compliance
Incidence of adverse events (AEs)
Retention

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

1 Treatment Group

Supportive care (coaching, exercise, questionnaire)
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Exercise Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Supportive care (coaching, exercise, questionnaire)Patients participate in one-on-one coaching sessions with a health coach QW to discuss the content offered in the program, and challenges they are currently facing in achieving their exercise goals. Patients receive a copy of the WWE workbook, wear a fitness tracker and are encouraged to achieve 150 minutes of walking per week during chemotherapy and up to 1 month after chemotherapy. Patients also participate in the Growing Stronger Strength Training Program and receive instruction manuals. They perform the initial 2 exercises 2 days per week for 4 weeks, and subsequent 2 exercises 2 days per week for the remainder of the chemotherapy course. Patients maintain exercise logs and complete questionnaires over 30-45 minutes at baseline, end of chemotherapy and at 1 month after chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Discussion
2018
N/A
~80

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 1 month after chemotherapy
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline up to 1 month after chemotherapy for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for female patients aged 65 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Willing and able to meet all study requirements
Patient-assessed ability to walk and engage in moderate physical activity
Age 65 years or older, female
Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
Scheduled to begin adjuvant or neoadjuvant chemotherapy regimen either as standard-of-care or on study
English or Spanish speaking
Able to provide written, informed consent

Patient Q&A Section

What is the latest research for breast cancer?

"A wide range of research exists within the area of breast cancer. It is important that clinicians see all relevant research to inform their clinical practice." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing breast cancer?

"The risk of developing breast cancer increases with age. The overall risk of developing breast cancer is approximately 1% over a lifetime. However, the risk is much higher among women aged 50 or older." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for breast cancer?

"Given that the risk of adverse events outweighs any potential benefit, we recommend against offering clinical trial participation to women who have had lumpectomy for DCIS or BCA. However, because the risk of adverse effects does not appear to be higher for patients with invasive disease, we propose that women with invasive disease who want to receive adjuvant therapy may wish to participate in clinical trials. Clinicians' concern about the adverse effects of clinical trials could be reduced through earlier identification of those most likely to be harmed." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving exercise intervention?

"Although there are few published studies evaluating the effect of exercise on osteoporosis, there are several randomized controlled trials proving its effectiveness. However, the results of these studies were obtained by means of conventional therapies. Therefore, the possibility of obtaining positive outcomes from regular physical exercise cannot be ruled out, especially if the patient is enrolled in a program supervised by a personal trainer or physiotherapist. In addition, recent research suggests that a combination of exercise and antiinflammatory drugs can have a beneficial effect on atherosclerosis. Moreover, a recent study indicates that mothers who exercised regularly during pregnancy had fewer children with autism (although not all mothers responded positively). Recent findings demonstrate that the benefits of exercise may be more extensive than previously thought." - Anonymous Online Contributor

Unverified Answer

What does exercise intervention usually treat?

"The present study suggests that exercise reduces pain and fatigue associated with chemotherapy-induced peripheral neuropathy, which could improve patients' quality of life. Results from a recent clinical trial suggest that clinicians should encourage their patients to participate in regular aerobic exercise programs as part of their rehabilitation regimen even during the period of chemotherapy." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating breast cancer?

"The advent of chemotherapy has been particularly beneficial because of its effect on delaying tumor growth and increasing survival rates. More importantly, recent findings are helping us discover other effective treatments for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). There are several different types of therapeutic agents available today which have given women with breast cancer much hope for their future treatment. Other advances include the development of monoclonal antibodies and the use of antiestrogens to treat breast cancer. Recent statistical data suggest that breast-conserving surgery combined with radiation therapy remains the most effective method of treatment for early stage breast cancers. In addition, research continues to develop new therapeutic agents for breast cancer patients. Further research should focus on developing new forms of therapy and identifying the specific genes responsible for breast cancer progression." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"Results from a recent paper shows that there are many signs associated with breast cancer. The signs should always be investigated by a qualified healthcare professional before initiating treatment.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"There are many different treatments available for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). Although some treatment options may be used to treat the same type of breast cancer, there are no universal standards for treating any type of breast cancer. For example, when the patient is diagnosed with triple negative breast cancer, then the doctor will want to use a different treatment option depending on what kind of cancer she has. Different treatments can help patients feel better and live longer lives with breast cancer. These treatments include surgery, radiation therapy, chemotherapy, hormonal therapy, targeted therapies, and immunotherapy. Each treatment method has its own drawbacks and benefits. Most patients will need multiple treatment options to find the best one for their particular case." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for breast cancer?

"Survival rate was higher in women aged <50 years compared to those aged 50-79 years. In addition, in women aged ≥ 80 years, chemotherapy was more frequently used than endocrine therapy." - Anonymous Online Contributor

Unverified Answer

How serious can breast cancer be?

"Seriousness is not directly related to age or stage. However, there are several factors associated with seriousness, including gender, marital status, and type of treatment." - Anonymous Online Contributor

Unverified Answer

Has exercise intervention proven to be more effective than a placebo?

"Data from a recent study suggest that regular exercise may be used as a preventive measure against breast cancer; however, further studies using larger samples are needed to validate these results." - Anonymous Online Contributor

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