Lifestyle Interventions for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Recurrent cancer, Psychiatric disorders, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

110 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Lifestyle Interventions for Breast Cancer?

Research shows that lifestyle interventions, including diet, exercise, and mindfulness, can improve the quality of life and health of breast cancer survivors. These programs have been associated with better physical and role functioning, weight loss, and adherence to a healthy diet, which may help manage cancer symptoms and enhance overall well-being. ^{1 2 3 4 5}

Is it safe to use lifestyle interventions like dietary supplements and exercise for breast cancer?

While lifestyle interventions such as dietary supplements and exercise are commonly used by breast cancer patients, there is a potential risk of harmful interactions between dietary supplements and cancer medications, which could increase side effects or reduce treatment effectiveness. ^{6 7 8 9 10}

How does the Integrative Oncology Program treatment differ from other treatments for breast cancer?

The Integrative Oncology Program is unique because it combines diet, exercise, and mindfulness to improve the quality of life and manage symptoms for breast cancer survivors, unlike traditional treatments that may focus solely on medical or surgical interventions. This holistic approach addresses both physical and emotional health, promoting a healthier lifestyle and potentially reducing cancer recurrence risk. ^{2 11 12 13 14}

What is the purpose of this trial?

This randomized clinical trial studies an integrative oncology (making changes in lifestyle and behavior) program in improving cancer-related outcomes in patients with stage II or III breast cancer undergoing radiation therapy. An integrative oncology program consisting of dietary recommendations, physical activity, stress management, social support, and control of environmental contaminants may modify cancer-related biological processes, influence long-term treatment results, and improve the quality of life of patients.

Research Team

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for English-speaking women with stage II or III breast cancer who are about to start a 4-6 week course of radiotherapy. They should be oriented and have a BMI of at least 24.45. Participants must also have poor lifestyle habits, like eating less than three servings of fruits and vegetables per day, exercising minimally, and rarely engaging in mind-body practices.

Inclusion Criteria

I am a woman with stage II or III breast cancer scheduled for 4-6 weeks of radiotherapy.

You need to have a BMI of 24.45 or higher, which is a measure of your weight in relation to your height.

I am aware of who I am, where I am, and the current time.

Exclusion Criteria

I have not had another primary cancer diagnosis in the last 5 years, except for non-melanoma skin cancers.

My diabetes is not well-managed according to my doctor.

I have difficulty hearing or communicating.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy and Integrative Oncology Interventions

Patients undergo up to 7 different IO intervention sessions per week during their 6-week course of radiotherapy, including nutritional coaching, behavioral therapy, yoga and meditation practice, resistance training, and a weekly meal sharing and cooking class.

6 weeks

Up to 7 visits per week (in-person)

Follow-up

Participants have weekly meetings with the study psychologist on the computer for 6 months, followed by monthly meetings from 6-12 months, and 2-hour meetings at all follow-up appointments during the first year after radiotherapy. Patients are followed up at 6 and 12 months and then annually for up to 4 years.

Up to 5 years

Treatment Details

Interventions

• Behavioral, Psychological or Informational Intervention
• Best Practice
• Cognitive Intervention
• Computer-Assisted Intervention
• Counseling
• Exercise Intervention
• Integrative Oncology Program
• Laboratory Biomarker Analysis
• Questionnaire Administration

Trial Overview The study tests an integrative oncology program that includes diet changes, exercise, stress management, social support, and reducing environmental toxins during radiation therapy to see if it improves biological processes related to cancer and enhances patients' quality of life.

Participant Groups

Group I: Arm I (IO interventions) Experimental Treatment 8 Interventions

Patients undergo up to 7 different IO intervention sessions per week during their 6-week course of radiotherapy for between 1 and 3 hours each session, in addition to, up to 6 aerobic training sessions per week and one grocery store trip during the course of the program. IO intervention programs consist of nutritional coaching, behavioral therapy, yoga and meditation practice, resistance training, and a weekly meal sharing and cooking class. Patients then have weekly meetings with the study psychologist on the computer for 6 months, followed by a monthly meeting on the computer from 6-12 months, and 2 hour meetings at all follow-up appointments during the first year after radiotherapy.

Group II: Arm II (standard of care) Active Control 4 Interventions

Patients undergo standard of care.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A 12-month lifestyle modification program, including a Mediterranean diet, exercise, and vitamin D supplementation, significantly improved health-related quality of life (HRQoL) in 227 breast cancer survivors, with notable increases in global health status and reductions in fatigue and other symptoms.

The study suggests that maintaining a healthy lifestyle can enhance HRQoL by potentially reducing body weight and improving vitamin D levels, which may alleviate breast cancer-related symptoms and positively influence treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life in Women Diagnosed with Breast Cancer after a 12-Month Treatment of Lifestyle Modifications. Montagnese, C., Porciello, G., Vitale, S., et al.[2021]

In a study of 1,000 women diagnosed with breast cancer, 96.5% reported using at least one form of complementary and alternative medicine (CAM) prior to their diagnosis, indicating a high prevalence of CAM use among this population.

After diagnosis, 86.1% of participants continued to use CAM, with common practices including botanical supplements, mind-body healing, and special diets, highlighting the importance for healthcare providers to discuss CAM options with breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and alternative therapy use before and after breast cancer diagnosis: the Pathways Study. Greenlee, H., Kwan, ML., Ergas, IJ., et al.[2022]

A predominantly plant-based diet, along with regular physical activity and maintaining a healthy weight, plays a crucial role in preventing breast cancer and supporting treatment.

The article emphasizes the importance of personalized lifestyle recommendations for patients, based on evidence from the World Cancer Research Fund/American Institute for Cancer Research, to enhance cancer prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer: A Lifestyle Medicine Approach. Orman, A., Johnson, DL., Comander, A., et al.[2021]

Lifestyle interventions that include nutrition education, physical activity, and stress management can significantly improve the overall health of breast cancer patients.

Implementing a structured lifestyle intervention program is essential for enhancing the well-being of individuals undergoing treatment for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Intervention for Breast Cancer Women. Hwang, ES., Nho, JH.[2020]

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Breast Cancer Survivorship and Level of Institutional Involvement Utilizing Integrative Oncology. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Influence of a Multidisciplinary Program of Diet, Exercise, and Mindfulness on the Quality of Life of Stage IIA-IIB Breast Cancer Survivors. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Using mixed methods for evaluating an integrative approach to cancer care: a case study. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

How do we evaluate outcome in an integrative oncology program? [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Quality of Life in Women Diagnosed with Breast Cancer after a 12-Month Treatment of Lifestyle Modifications. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Dietary supplement use and recommendations for discontinuation in an integrative oncology clinic. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Interest in Integrative Medicine Among Postmenopausal Hormone Receptor-Positive Breast Cancer Patients in the EvAluate-TM Study. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Complementary and alternative therapy use before and after breast cancer diagnosis: the Pathways Study. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Supplement Use and Interactions with Tamoxifen and Aromatase Inhibitors in Breast Cancer Survivors Enrolled in Lifestyle Interventions. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Utilization of Complementary Alternative Medicine, Diet, and Exercise Among Women at High Risk for Developing Breast Cancer. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Breast Cancer: A Lifestyle Medicine Approach. [2021]

12. England pubmed.ncbi.nlm.nih.gov

A Wellness Program for Cancer Survivors and Caregivers: Developing an Integrative Pilot Program with Exercise, Nutrition, and Complementary Medicine. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Study protocol to investigate the effect of a lifestyle intervention on body weight, psychological health status and risk factors associated with disease recurrence in women recovering from breast cancer treatment [ISRCTN08045231]. [2023]

14. Korea (South) pubmed.ncbi.nlm.nih.gov

Lifestyle Intervention for Breast Cancer Women. [2020]