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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

People with non-small cell lung cancer are at risk for nutritional deficiencies. The purpose of this study is to find out what effects a nutritional product has on patient's response to immunotherapy or combination of immunotherapy and chemotherapy. To do this, some of the participants will get the nutritional product and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable. Participants will be randomized to any of the following treatment groups: - Group 1 (Experimental intervention): standard intervention of immunotherapy or combination of immunotherapy and chemotherapy plus the experimental intervention nutritional product. Group 2 (Non-experimental intervention): standard intervention of immunotherapy or combination of immunotherapy and chemotherapy plus the non-experimental intervention placebo product. Participants will take 5 capsules each day by mouth, starting on the first day of immunotherapy with or without chemotherapy and stopping upon completion of their immunotherapy with or without chemotherapy treatment. Participants will complete a diary of their nutritional/ placebo product intake and will undergo the following assessments: * Physical examination. * Height and weight. * ECOG status (the physician will record the impact on the cancer on daily living abilities). * Concomitant medications recording. * Adverse Event Assessment * Computed tomography (CT) scan. A series of x-rays of the body from many angles that are turned into 3-dimensional pictures on a screen. * Quality of life questionnaires. * Blood collection

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.

What data supports the effectiveness of the treatment Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for lung cancer?

Research shows that omega-3 fatty acids like EPA and DHA can help improve nutritional status and reduce inflammation in lung cancer patients, which may support better overall health during treatment. ^{1 2 3 4 5}

Is the nutritional supplement containing omega-3 fatty acids safe for humans?

Research shows that omega-3 fatty acids, like those found in fish oil, are generally safe for humans and may have anti-inflammatory and antioxidant effects. Studies in cancer patients have shown that these supplements can help maintain body weight and improve nutritional status without significant safety concerns. ^{1 4 5 6 7}

How does the nutritional supplement for lung cancer differ from other treatments?

This nutritional supplement is unique because it contains omega-3 fatty acids, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which have immune-modulating and anti-inflammatory effects. Unlike standard cancer treatments, this supplement aims to improve nutritional status and reduce inflammation, potentially enhancing the overall quality of life for lung cancer patients. ^{1 2 3 4 5}

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. Switzerland 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. [2021]

3. England 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. [2022]

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

Effect of n-3 fatty acids on patients with advanced lung cancer: a double-blind, placebo-controlled study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Omega-3 supplements for patients in chemotherapy and/or radiotherapy: A systematic review. [2022]

6. United States 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. [2023]

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

Omega-3 fatty acids as cancer chemopreventive agents. [2022]