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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the practicality and reception of a program called the Anti-Inflammatory Lifestyle Intervention for young adult cancer survivors. The program includes virtual group meetings over 16 weeks, focusing on lifestyle changes that may help reduce inflammation. It targets individuals aged 18-29 with a history of cancer who meet specific body fat criteria. Participants should not have received cancer treatment in the past six months and should not have any major health issues that could interfere with study activities. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance the quality of life for young cancer survivors.

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 prior data suggests that this intervention is safe for cancer survivors?

Research has shown that an anti-inflammatory lifestyle is generally safe for cancer survivors. This lifestyle involves reducing inflammation through diet and behavior changes, which might improve survival rates and lower the risk of cancer recurrence.

An anti-inflammatory diet has been linked to better survival outcomes. This diet avoids foods that can cause inflammation, a process harmful to health. By following this diet, cancer survivors may reduce the chances of health issues returning.

Although specific data on side effects from this lifestyle change is lacking, healthier eating and positive lifestyle changes are usually well-tolerated and considered safe. Therefore, individuals interested in this kind of trial can feel more confident about its safety based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Anti-Inflammatory Lifestyle Intervention for cancer survivors because it offers a holistic approach that goes beyond traditional treatments like chemotherapy and radiation. This intervention focuses on lifestyle changes that can reduce inflammation, which is believed to play a role in cancer progression and recurrence. By engaging participants in a 16-week program with virtual group meetings, it emphasizes accessible, community-based support. Unlike standard treatments that often have significant side effects, this approach aims to empower survivors to improve their health through sustainable habits, potentially enhancing their quality of life in the long run.

What evidence suggests that the Anti-Inflammatory Lifestyle Intervention might be effective for cancer survivors?

Studies have shown that lifestyle changes to reduce inflammation can benefit cancer survivors. These changes can lessen treatment side effects and decrease the risk of cancer recurrence. A review of multiple studies found that they can also boost emotional well-being and overall quality of life. Research suggests that an anti-inflammatory diet may improve survival rates for cancer survivors. These findings indicate that such lifestyle changes could benefit young adult cancer survivors. This trial will evaluate the Anti-Inflammatory Lifestyle Intervention, a 16-week program with 12 virtual group meetings, each lasting 75 minutes, to assess its impact on cancer survivors. ^{1 3 4 6 7}

Who Is on the Research Team?

Autumn Lanoye, Ph.D

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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

Individuals currently pregnant or lactating

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

I am currently undergoing chemotherapy or radiation therapy.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06442397

Anti-Inflammatory Lifestyle Intervention for Emerging Adult ... This is a single-arm pilot trial designed to assess the feasibility and acceptability of an anti-inflammatory lifestyle intervention (AILI) for emerging adults ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10156067/

Effect of an anti-inflammatory dietary intervention on quality ... The intervention reduced perceived stress at 6-month follow-up, but the effects dissipated by 12 months.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12081566/

A meta-analysis of healthy lifestyle interventions addressing ... Such interventions have demonstrated efficacy in (a) reducing treatment-related side effects, cancer recurrence and mortality [8], and (b) improving emotional ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0378512224000720

The effects of lifestyle and behavioural interventions on ... This study aimed to assess and compare the effects of lifestyle/behavioural interventions on cancer recurrence, survival and QoL in breast cancer survivors.

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1467259/full

Analysis of dietary inflammatory potential and mortality in ... Conclusion: Adoption of an anti-inflammatory diet, characterized by lower DII scores, may improve survival outcomes in cancer survivors. These results emphasize ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10582578/

The relationship between dietary inflammatory potential and ... Inflammatory diet can increase all-cause mortality by 34% among cancer survivors. Only post-diagnosis diet had a significant association with all-cause ...

7. nature.com nature.com/articles/s41523-020-00179-4

Long-term anti-inflammatory diet in relation to improved ... showed that anti-inflammatory diets may decrease the risk of cancer recurrence and overall mortality in patients with breast cancer, while ...