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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if lifestyle changes can improve outcomes for women with stage II or III breast cancer undergoing radiation therapy. Participants will engage in an integrative oncology program that includes diet changes, exercise, stress management, and social support. The trial will compare this program to standard cancer care. Women with stage II or III breast cancer who engage in less physical activity or consume fewer fruits and vegetables may be suitable candidates. As an unphased trial, participants contribute to valuable research that may enhance cancer care strategies.

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 prior data suggests that this integrative oncology program is safe for breast cancer patients?

Research has shown that integrative oncology programs are generally safe. These programs combine standard cancer treatments with lifestyle changes, such as healthier eating and increased exercise. Studies have found these approaches to be safe and effective for breast cancer patients, aiming to enhance overall health and quality of life without adding risk.

The integrative oncology approach includes conventional treatments along with activities like yoga, meditation, and nutritional support. These methods have been shown to be safe and can help patients feel better during and after cancer treatment. Safety studies on these programs have not reported significant negative effects, indicating they are well-tolerated.

Typically, if a treatment reaches this stage of research, it has passed earlier safety checks. Evidence supports that these lifestyle changes can be safely added to traditional cancer therapies, justifying their use in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrative Oncology (IO) Program for breast cancer because it offers a holistic approach that goes beyond traditional treatments like surgery, chemotherapy, and radiation. Unlike the standard of care, which primarily focuses on medical interventions, this program combines multiple lifestyle interventions such as nutritional coaching, yoga, meditation, and aerobic training. The IO Program is distinctive because it not only aims to support physical health but also emphasizes mental well-being through behavioral therapy and psychological support. This comprehensive approach could potentially enhance overall quality of life and improve long-term outcomes for patients.

What evidence suggests that this trial's integrative oncology program could be effective for breast cancer?

Research has shown that combining integrative oncology (IO) with standard cancer treatment can significantly improve outcomes for breast cancer patients. In this trial, participants in Arm I will undergo IO interventions, which include lifestyle changes such as healthier eating, exercising, and stress management. One study found that IO reduced the risk of death by 64% for those with stage II breast cancer. Another study demonstrated that the IO approach improved the quality of life for breast cancer patients. These findings suggest that an IO program could be crucial for enhancing long-term treatment results and overall well-being for breast cancer patients. Meanwhile, participants in Arm II will receive standard care treatment. ^{1 4 6 7 8}

Who Is on the Research Team?

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01366248

Integrative Oncology Outcomes Study in Breast Cancer Describe and compare the frequency of use of a variety of CAM treatments used by breast cancer patients who do (Cohort 1A) and do not (Cohorts 2A and 2B) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4739815/

Can we demonstrate that breast cancer “Integrative ... IO combined with conventional therapy, compared with conventional therapy alone, reduced the risk of death in stage I by 95%, stage II by 64%, ...

3. mbcalliance.org mbcalliance.org/guestblogposts/integrative-oncology-thriving-with-metastatic-breast-cancer-mbc/

Integrative Oncology: Thriving with Metastatic Breast ... According to a 2017 study by Terri Crudup and associates, using the Integrative Oncology model showed improvements in breast cancer quality of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5736066/

Breast Cancer Integrative Oncology Care and Its Costs - PMC IO care for women with breast cancer consists of botanical and mushroom oral therapies, parenteral botanical and nutrient therapy, mind-body medicine and ...

5. ascopubs.org ascopubs.org/doi/10.1200/EDBK_431554

Integrative Therapies in Cancer Care: An Update on the ... These guidelines provide evidence-based recommendations to improve outcomes and quality of life by enhancing conventional cancer treatment with integrative ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22740079/

Can we demonstrate that breast cancer "integrative oncology ... It may provide valuable data for the evaluation of the effectiveness of IO care on patient health, relapse rate, and health-related quality of life (HRQOL).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3582454/

Integrative oncology for breast cancer patients - PubMed Central Both IM and IO combine conventional with other medical approaches that have been shown to be safe and effective [3] (see Figure 1). Phrases such ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900725001777

Challenges in implementing a multidisciplinary integrative ... This study examines the challenges and facilitators in implementing a lifestyle and integrative oncology intervention, which aims to provide education and ...