Anti-Inflammatory Lifestyle Intervention for Cancer Survivors

(HEAL Trial)

Overseen By Massey Cancer Prevention & Control Team

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Uncontrolled hypertension, Bipolar, others

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

Compensation: Varies

Number of Visits: 12

Duration: 16 weeks

19 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on weight loss medication or have certain medical conditions, you may not be eligible to participate.

What data supports the effectiveness of the Anti-Inflammatory Lifestyle Intervention treatment for cancer survivors?

Research suggests that following an anti-inflammatory diet after a cancer diagnosis may help reduce the risk of death from all causes and cardiovascular disease among cancer survivors, potentially improving their overall survival. ^{1 2 3 4 5}

How is the Anti-Inflammatory Lifestyle Intervention treatment different from other treatments for cancer survivors?

The Anti-Inflammatory Lifestyle Intervention (AILI) is unique because it focuses on dietary changes to reduce inflammation, which can improve survival rates for cancer survivors. Unlike traditional treatments that may involve medication or surgery, AILI emphasizes a Mediterranean-style diet rich in anti-inflammatory foods, herbs, and spices to create a healthier environment in the body. ^{1 2 5 6 7}

What is the purpose of this trial?

To test the feasibility and acceptability of AILI and associated research procedures among emerging adult cancer survivors (EACS, N=16) age 18-29.

Research Team

Autumn Lanoye, Ph.D

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for young adults aged 18-29 who have survived cancer. It's designed to see if they can participate in and accept a program aimed at reducing inflammation through lifestyle changes.

Inclusion Criteria

I have been diagnosed with cancer.

Exclusion Criteria

I am currently undergoing chemotherapy or radiation therapy.

Individuals currently pregnant or lactating

I am currently in a weight loss program or taking weight loss medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 16-week Anti-Inflammatory Lifestyle Intervention consisting of 12 virtual group meetings

16 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of post-intervention questionnaire and blood draw

4 weeks

Treatment Details

Interventions

• Anti-Inflammatory Lifestyle Intervention

Trial Overview The study is testing an Anti-Inflammatory Lifestyle Intervention (AILI) which may include diet, exercise, and stress management techniques tailored for those who've had cancer during their late teens and twenties.

Participant Groups

Group I: Anti-Inflammatory Lifestyle Intervention Experimental Treatment 1 Intervention

A 16-week program consisting of 12 75-minute virtual group meetings

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Findings from Research

In a study of 1064 female breast cancer survivors with a median follow-up of 14.6 years, a higher dietary inflammatory index (E-DII) was linked to increased risks of all-cause mortality (34% higher) and breast cancer-specific mortality (47% higher) compared to those with lower E-DII scores.

The findings suggest that adopting a long-term anti-inflammatory diet may improve survival rates for breast cancer survivors, highlighting the potential importance of diet in post-diagnosis care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term anti-inflammatory diet in relation to improved breast cancer prognosis: a prospective cohort study. Wang, K., Sun, JZ., Wu, QX., et al.[2023]

A systematic review of 13 studies involving 14,920 cancer survivors found that a high Dietary Inflammatory Index (DII) was not linked to an increased risk of cancer recurrence or overall cancer-specific mortality.

However, a higher DII post-diagnosis was associated with a 34% increased risk of all-cause mortality, suggesting that adopting a more anti-inflammatory diet after cancer diagnosis may help reduce mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between dietary inflammatory potential and cancer outcomes among cancer survivors: A systematic review and meta-analysis of cohort studies. Han, E., Lee, E., Sukhu, B., et al.[2023]

In a study of 2,150 postmenopausal women diagnosed with invasive breast cancer, a more anti-inflammatory diet was linked to a significantly lower risk of cardiovascular disease (CVD) mortality, suggesting dietary choices can impact long-term health outcomes after cancer diagnosis.

However, the study found no significant association between dietary inflammatory potential and breast cancer-specific mortality or all-cause mortality, indicating that while diet may help with CVD risk, it does not appear to affect breast cancer survival directly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Post-Cancer Diagnosis Dietary Inflammatory Potential and Mortality among Invasive Breast Cancer Survivors in the Women's Health Initiative. Zheng, J., Tabung, FK., Zhang, J., et al.[2021]

Chronic inflammation can promote cancer development, so reducing risk factors that lead to chronic inflammation is crucial for lowering cancer incidence.

Combining treatments that target chronic inflammation with those that enhance the body's immune response may improve cancer treatment outcomes and patient survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic inflammation and immunologic-based constraints in malignant disease. Lowe, DB., Storkus, WJ.[2021]

Breast cancer survivors who consume pro-inflammatory diets face a higher risk of mortality and worse prognosis, highlighting the impact of nutrition on health outcomes after diagnosis.

In contrast, anti-inflammatory diets, particularly the Mediterranean diet, are linked to reduced recurrence risk and improved quality of life for breast cancer survivors, suggesting dietary management can play a crucial role in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflammation, Nutrition, and Clinical Outcomes in Breast Cancer Survivors: A Narrative Review. Pannu, MK., Constantinou, C.[2023]

A 6-month dietary intervention for breast cancer survivors significantly improved adherence to a Mediterranean-style diet, with the intervention group increasing their adherence by 22.5% compared to only 2.7% in the control group.

The intervention led to a notable increase in the consumption of anti-inflammatory foods, herbs, and spices, particularly cinnamon, turmeric, and garlic, while also reducing the intake of red meat and sweets, suggesting a positive shift towards healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intervention among breast cancer survivors increased adherence to a Mediterranean-style, anti-inflammatory dietary pattern: the Rx for Better Breast Health Randomized Controlled Trial. Zuniga, KE., Parma, DL., Muñoz, E., et al.[2020]

In a study involving 253 breast cancer patients and 267 controls, higher dietary inflammation scores (DIS) and empirical dietary inflammatory index (EDII) were associated with a significantly increased risk of breast cancer, with odds ratios of 2.13 and 2.17, respectively.

No significant link was found between lifestyle inflammation scores (LIS) and breast cancer risk, indicating that dietary factors may play a more critical role in inflammation-related cancer risk than lifestyle factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between novel dietary and lifestyle inflammation indices with risk of breast cancer (BrCa): a case-control study. Sohouli, MH., Hadizadeh, M., Mardali, F., et al.[2022]

References

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

Long-term anti-inflammatory diet in relation to improved breast cancer prognosis: a prospective cohort study. [2023]

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

The relationship between dietary inflammatory potential and cancer outcomes among cancer survivors: A systematic review and meta-analysis of cohort studies. [2023]

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

Association between Post-Cancer Diagnosis Dietary Inflammatory Potential and Mortality among Invasive Breast Cancer Survivors in the Women's Health Initiative. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Chronic inflammation and immunologic-based constraints in malignant disease. [2021]

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

Inflammation, Nutrition, and Clinical Outcomes in Breast Cancer Survivors: A Narrative Review. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Dietary intervention among breast cancer survivors increased adherence to a Mediterranean-style, anti-inflammatory dietary pattern: the Rx for Better Breast Health Randomized Controlled Trial. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Association between novel dietary and lifestyle inflammation indices with risk of breast cancer (BrCa): a case-control study. [2022]