Nutritional Supplement for Lung Cancer

Overseen By Quicy Chu, MD, FRCP (C)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AHS Cancer Control Alberta

Must not be taking: Supplements, Steroids, NSAIDs

Disqualifiers: Other malignancy, Brain metastases, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a nutritional supplement might affect the response to immunotherapy or a combination of immunotherapy and chemotherapy in people with non-small cell lung cancer. The study aims to determine if adding this supplement, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), can improve treatment outcomes for those at risk of nutritional deficiencies. Participants will be divided into two groups: one will receive the experimental nutritional supplement, and the other a placebo. The trial seeks individuals with advanced lung cancer who have not received certain therapies before, including those who have experienced significant weight loss in the past six months.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance future treatment options for lung cancer patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must stop taking any supplements containing the nutritional supplement under study at least 30 days before enrolling.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that omega-3 fatty acids, such as EPA and DHA, are generally safe for people. Studies have found that these fatty acids can target cancer cells without harming normal cells, suggesting they might be safe for cancer patients.

A review of several studies noted a small increase in cancer risk, but it wasn't significant. This indicates that the risk wasn't clearly higher when taking omega-3 supplements. Overall, these findings suggest that while omega-3 fatty acids may affect cancer cells, they are usually safe and don't cause major side effects for most people.

Participants should discuss any concerns with their healthcare provider, especially if they have other health conditions or are taking other medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as a nutritional supplement for lung cancer because these omega-3 fatty acids may offer a novel approach in cancer treatment. Unlike traditional options like chemotherapy and immunotherapy, which directly target cancer cells or boost the immune system, EPA and DHA could work by modulating inflammation and improving the overall nutritional status of patients. This could potentially enhance the effectiveness of existing treatments and improve patients' quality of life. Additionally, being a nutritional supplement, it might come with fewer side effects compared to conventional cancer therapies.

What evidence suggests that this nutritional supplement could be effective for lung cancer?

Research has shown that certain nutrients in fish oil, called omega-3 fatty acids, can aid people with lung cancer undergoing treatment. These nutrients, known as EPA and DHA, may reduce inflammation, a common issue for cancer patients. They might also help manage ongoing inflammation and boost the immune system during chemotherapy. Some studies suggest that EPA and DHA could help prevent muscle loss, another frequent problem for cancer patients. In this trial, participants in the experimental intervention arm will receive a nutritional supplement containing EPA and DHA alongside standard cancer treatments. Overall, these nutrients might support better health and potentially improve treatment results for those undergoing cancer therapy. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Adults over 18 with stage IIIB/IV non-small cell lung cancer without certain mutations, who've finished curative therapy at least a year ago and are starting chemotherapy or immunotherapy. They must be able to swallow capsules, have no severe allergies to the trial's ingredients, controlled diabetes, no recent blood transfusions or other malignancies within two years (except some cured skin cancers), and not be on conflicting treatments.

Inclusion Criteria

Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up

I have advanced lung cancer without EGFR or ALK mutations and agree to chemotherapy or immunotherapy.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures

Your blood has low levels of albumin (a type of protein).

I haven't had any cancer needing treatment in the last 2 years, except for minor skin, bladder, cervix, or breast cancers that were cured.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immunotherapy or a combination of immunotherapy and chemotherapy along with either a nutritional supplement or placebo for 4 cycles, each cycle lasting 21 days

12 weeks

Visits at the start of each cycle and end of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and disease progression

4 weeks

Long-term follow-up

Analysis of 1-year survival and progression-free survival data

What Are the Treatments Tested in This Trial?

Interventions

• Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
• Nutritional supplement
• Placebo

Trial Overview The trial is testing if a nutritional supplement can improve responses to standard lung cancer treatments. Participants will either receive this supplement or a placebo alongside their regular treatment of immunotherapy or chemotherapy. They'll take five capsules daily from the start of their treatment until it ends and keep track of intake in a diary.

How Is the Trial Designed?

Group I: Experimental intervention Experimental Treatment 1 Intervention

Standard intervention of immunotherapy or combination of immunotherapy and chemotherapy, plus the experimental intervention nutritional product.

Group II: Non-experimental intervention Placebo Group 1 Intervention

Standard intervention of immunotherapy or combination of immunotherapy and chemotherapy, plus the non-experimental intervention placebo product.

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Published Research Related to This Trial

A systematic review of 10 high-quality randomized controlled trials found that omega-3 fatty acids (EPA and DHA) supplements during chemotherapy and/or radiotherapy can help preserve body composition and improve various health outcomes without causing worse results for patients.

While omega-3 supplementation showed benefits in terms of body weight and overall health during cancer treatment, it did not significantly reduce tumor size or extend patient survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 supplements for patients in chemotherapy and/or radiotherapy: A systematic review. de Aguiar Pastore Silva, J., Emilia de Souza Fabre, M., Waitzberg, DL.[2022]

In a study of 60 lung cancer patients over 12 weeks, omega-3 fatty acid supplementation significantly improved nutritional status, as evidenced by increased weight and albumin levels compared to a placebo group.

The omega-3 group also showed a notable reduction in inflammatory markers, such as C-reactive protein and tumor necrosis factor alpha, indicating a potential benefit in managing inflammation associated with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 Fatty Acids Supplementation Improve Nutritional Status and Inflammatory Response in Patients With Lung Cancer: A Randomized Clinical Trial. Cheng, M., Zhang, S., Ning, C., et al.[2021]

In a study of 40 patients with stage III non-small cell lung cancer, an oral nutritional supplement containing (n-3) fatty acids significantly improved weight maintenance and fat-free mass compared to a control supplement after 2 to 5 weeks of treatment.

The (n-3) fatty acid supplement also led to increased energy and protein intake, reduced resting energy expenditure, and a trend towards lower inflammatory markers, suggesting it may enhance nutritional status and modulate inflammation during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral nutritional supplements containing (n-3) polyunsaturated fatty acids affect the nutritional status of patients with stage III non-small cell lung cancer during multimodality treatment. van der Meij, BS., Langius, JA., Smit, EF., et al.[2023]

Long-chain omega-3 fatty acids, found in high levels in certain fish oils, may help protect against common cancers like breast and colon cancer, based on both epidemiological and experimental evidence.

These protective effects are thought to work through various mechanisms, including inhibiting cancer cell growth and promoting cell death, primarily by reducing the production of harmful eicosanoids from omega-6 fatty acids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids as cancer chemopreventive agents. Rose, DP., Connolly, JM.[2022]

A new LC-MS/MS method was developed to accurately measure levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in serum, which is crucial for studying their role in non-small-cell lung cancer (NSCLC).

The study found that serum levels of EPA and DHA were significantly lower in 211 NSCLC patients compared to 227 healthy controls, indicating a potential link between these fatty acids and the progression of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced levels of serum EPA and DHA identified in patients with non-small-cell lung cancer using a new rapid validated LC-MS/MS method. Wang, Y., Yin, T., Li, J., et al.[2023]

In a study involving 33 patients with advanced lung cancer, supplementation with EPA and DHA from fish oil led to a significant increase in body weight and demonstrated anti-inflammatory effects by reducing C-reactive protein and IL-6 levels during chemotherapy.

The n-3 group showed improved oxidative status, with lower levels of reactive oxygen species and stabilized hydroxynonenal levels compared to the placebo group, suggesting that EPA and DHA may help mitigate oxidative stress in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of n-3 fatty acids on patients with advanced lung cancer: a double-blind, placebo-controlled study. Finocchiaro, C., Segre, O., Fadda, M., et al.[2022]

In a study of 40 patients with stage III non-small cell lung cancer, an oral nutritional supplement containing n-3 polyunsaturated fatty acids significantly improved quality of life, cognitive function, and global health status after 5 weeks compared to a control supplement.

The intervention group also showed a better Karnofsky Performance Status after 3 weeks and tended to have higher physical activity levels, suggesting that n-3 fatty acids may enhance overall well-being during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral nutritional supplements containing n-3 polyunsaturated fatty acids affect quality of life and functional status in lung cancer patients during multimodality treatment: an RCT. van der Meij, BS., Langius, JA., Spreeuwenberg, MD., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9303080/

Efficacy of ω-3 Polyunsaturated Fatty Acids in Patients with ... ω-3 PUFAs can improve nutritional status and regulate indicators of inflammation in patients with lung cancer undergoing radiotherapy and chemotherapy.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325001000

Perspective: Implications of Docosahexaenoic Acid and ... This review provides an overview of the clinical evidence on the immunomodulatory effects of omega-3 supplementation during cancer chemotherapy.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17927497/

Effects of eicosapentaenoic and docosahexaenoic n-3 fatty ... Eicosapentaenoic and docosahexaenoic n-3 fatty acids from fish oil can help in the management of persistent chronic inflammatory states, but treatment's ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01048970

Study Details | NCT01048970 | Effect on the Nutritional and ... N-3 fatty acids, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), may possess anticachectic properties. This trial compared a protein and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589004224028281

Roles and therapeutic opportunities of ω-3 long-chain ... The ω-3 LCPUFAs, primarily consisting of eicosapentaenoic acid and docosahexaenoic acid, were found to modify inflammatory tumor microenvironment.

6. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Omega 3 fatty acids overview for health professionals. Research health effects, dosing, sources, deficiency, side effects, and interactions here.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4773771/

Omega-3 Fatty Acids and Cancer Cell Cytotoxicity n-3 PUFAs appear to cause selective cytotoxicity towards cancer cells with little or no toxicity on normal cells.

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1811403

Marine n−3 Fatty Acids and Prevention of Cardiovascular ... A 2014 meta-analysis of 10 trials of n−3 fatty acids showed a risk of cancer that was nonsignificantly higher, by 10%, with the n−3 fatty acids ...

9. nature.com nature.com/articles/s41598-024-51967-y

Impact of serum eicosapentaenoic acid/arachidonic ... This pilot study analyzed the dietary patterns of patients with non-small cell lung cancer undergoing initial pembrolizumab, an immune checkpoint inhibitor ( ...