Lovaza + Curcumin for Lung Nodule Reduction

Overseen By Lary Robinson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Doxycycline, Tetracycline

Disqualifiers: Invasive cancer, Lung-RADS 4, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of Lovaza (a fish oil-based drug) and Curcumin C3 Complex (derived from turmeric) can shrink lung nodules. Researchers aim to determine if this combination is safe and well-tolerated. The trial includes different groups, with some receiving the combination treatment and others a placebo (a harmless pill resembling the real thing). Suitable candidates are former or current smokers, aged 55 or older, who have been screened for lung nodules and have smoked for at least 20 years. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires participants to stop taking any current vitamin or mineral supplements that contain components of the study agents. A standard multivitamin will be provided for the study. The protocol does not specify if you need to stop other medications, so it's best to discuss this with the trial team.

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

Research shows that the combination of Lovaza and Curcumin C3 Complex is being tested for safety in people. Lovaza contains omega-3 fatty acids, healthy fats found in fish oil, and is FDA-approved to lower very high triglyceride levels, a type of fat in the blood. Most people taking Lovaza do not experience major side effects.

Curcumin, derived from the turmeric root, is usually well-tolerated in other studies, with only mild side effects like stomach upset in some individuals. This study is in its early stages and aims to ensure the combination is safe for participants. Although specific safety data from this study is not yet available, the individual components have been used safely in other contexts. Participants should consider these points and consult their healthcare provider if they have any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Lovaza and Curcumin C3 complex for reducing lung nodules because these treatments bring something new to the table. Unlike most standard treatments, which often focus on surgery or chemotherapy, this combination leverages the anti-inflammatory and antioxidant properties of curcumin, a natural compound found in turmeric, alongside the omega-3-rich Lovaza, commonly used for heart health. This unique blend could potentially target lung nodules through a novel mechanism by reducing inflammation and oxidative stress, which are known contributors to nodule formation. Plus, the use of dietary supplements like curcumin and Lovaza may offer a less invasive and more natural option compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for lung nodule reduction?

This trial will test the combination of Lovaza, a fish oil supplement, and Curcumin C3 Complex to determine their effectiveness in shrinking lung nodules. Research has shown that both ingredients might prevent lung nodules from enlarging. Curcumin is known for reducing inflammation and potentially fighting tumors, while the fish oil in Lovaza is associated with various health benefits, including reduced inflammation. Participants in this trial will receive either the combination of Lovaza and Curcumin C3 Complex or a placebo to evaluate the treatments' effectiveness in managing lung nodules in smokers. Although more research is needed, early signs suggest this combination could be promising. ^{1 2 6 7 8}

Who Is on the Research Team?

Nagi Kumar, PhD

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Are You a Good Fit for This Trial?

This trial is for current or former smokers aged 55+ with a history of heavy smoking (≥20 pack years), who have certain types of lung nodules detected on CT scans. Participants must be able to swallow pills, undergo CT scans, and willing to stop taking any vitamin/mineral supplements that overlap with the study drugs.

Inclusion Criteria

My organs and bone marrow are functioning normally.

I am fully active or can carry out light work.

I am 55 years old or older.

Exclusion Criteria

I was diagnosed with invasive cancer, other than skin cancer, in the last 2 years.

I am not pregnant or breastfeeding.

You have a newly discovered lung nodule that meets specific size and shape criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lovaza and Curcumin C3 Complex or placebo for 6 months to assess reduction in lung nodule size and safety

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months

What Are the Treatments Tested in This Trial?

Interventions

• Curcumin C3 complex
• Lovaza
• Placebo

Trial Overview Researchers are testing if Lovaza (fish oil) combined with Curcumin C3 Complex can reduce the size of lung nodules in smokers. The safety and tolerability of this drug combination are also being evaluated in this phase II trial.

How Is the Trial Designed?

Group I: Curcumin C3 complex® +Lovaza® +Placebo Active Control 3 Interventions

Group B: 2 grams Lovaza®, 1 gram twice a day, AM and PM. 4,000 mgs CUR Curcumin C3 complex® tablets, 2,000 mgs twice a day, AM and PM. 1 placebo capsule twice a day, AM and PM.

Group II: Curcumin C3 complex® +Lovaza® Active Control 2 Interventions

Group A: 4 grams Lovaza®, 2 grams twice a day (BID). 2 grams by mouth daily, AM and PM 8,000 mgs CUR Curcumin C3 complex® tablets, divided into 2 doses. 4 grams by mouth, twice a day, AM and PM.

Group III: Placebo only Active Control 1 Intervention

Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM

Curcumin C3 complex is already approved in United States, European Union, Canada, India for the following indications:

Approved in United States as Curcumin C3 Complex for:

• Dietary Supplement
• Antioxidant

Approved in European Union as Curcumin C3 Complex for:

• Food Supplement
• Antioxidant

Approved in Canada as Curcumin C3 Complex for:

• Natural Health Product
• Antioxidant

Approved in India as Curcumin C3 Complex for:

• Ayurvedic Medicine
• Antioxidant

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

James and Esther King Biomedical Research Program

Collaborator

Trials

15

Recruited

2,200+

Published Research Related to This Trial

Curcumin, a natural compound from turmeric, shows significant antitumor activity against lung cancer by targeting multiple molecular pathways, including those involved in cell growth and survival, which can help reduce cancer cell viability and proliferation.

Curcumin not only enhances the effectiveness of chemotherapy and radiotherapy in lung cancer treatment but also improves the bioavailability of curcumin through nanocarriers, making it a promising adjunct therapy in cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Versatile role of curcumin and its derivatives in lung cancer therapy. Ashrafizadeh, M., Najafi, M., Makvandi, P., et al.[2021]

Curcumin, a natural compound from turmeric, has shown promise as a chemopreventive agent against lung cancer by inhibiting cell growth and promoting cell death in various cancer types, including non-small cell lung cancer.

The compound is not only effective in combating cancer but also possesses anti-inflammatory properties, making it a potentially valuable addition to cancer prevention strategies, especially for those affected by nicotine addiction from smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preventive role of curcumin in lung cancer]. Balcerek, M., Matławska, I.[2013]

Curcumin significantly reduced the incidence and number of adenomas in a colon cancer model in rats, demonstrating its potential as an effective chemopreventive agent, while quercetin increased tumor yield in the same model.

Neither curcumin nor quercetin showed significant effects on tumor incidence or multiplicity in a mammary cancer model, although both agents increased tumor latency, indicating different mechanisms of action in various cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the phytochemicals, curcumin and quercetin, upon azoxymethane-induced colon cancer and 7,12-dimethylbenz[a]anthracene-induced mammary cancer in rats. Pereira, MA., Grubbs, CJ., Barnes, LH., et al.[2019]

Curcumin, a compound found in turmeric, has shown potential therapeutic effects in treating pulmonary diseases by regulating key inflammatory factors, but most evidence comes from in vitro or animal studies rather than human trials.

The main challenge in using curcumin for treatment is its poor bioavailability, which may require the use of adjuvants or specialized delivery methods like nanoparticles to enhance its effectiveness in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin use in pulmonary diseases: State of the art and future perspectives. Lelli, D., Sahebkar, A., Johnston, TP., et al.[2018]

Curcumin, a natural anti-inflammatory compound, has demonstrated efficacy in treating various chronic conditions, including rheumatoid arthritis, inflammatory bowel disease, and several types of cancer, based on numerous experimental and pharmacologic trials.

Despite its potential benefits, there are existing gaps in research and application that have limited the widespread use of curcumin in the medical community, highlighting the need for further investigation into its therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin: An age-old anti-inflammatory and anti-neoplastic agent. Fadus, MC., Lau, C., Bikhchandani, J., et al.[2023]

Curcumin, a compound derived from turmeric, shows promise as a chemopreventive agent against lung cancer, particularly for high-risk groups such as ex-smokers and patients post-surgery.

The review highlights the need for more rationally designed lung cancer chemoprevention trials, as existing models often yield conflicting results, emphasizing the potential of dietary bioactive compounds like curcumin due to their favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating curcumin to the clinic for lung cancer prevention: evaluation of the preclinical evidence for its utility in primary, secondary, and tertiary prevention strategies. Howells, LM., Mahale, J., Sale, S., et al.[2022]

Curcumin I and Curcumin III, compounds from turmeric, have been shown to inhibit cancer development at various stages, including initiation and promotion, in animal models, such as Swiss mice.

Both curcumins demonstrated cytotoxic effects against human chronic myeloid leukemia cells in vitro, indicating their potential as therapeutic agents in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin as an inhibitor of cancer. Nagabhushan, M., Bhide, SV.[2013]

Curcumin (Cum) significantly enhances the antitumor effects of Docetaxel (Doc), a standard chemotherapy for non-small cell lung cancer, showing a synergistic interaction in both in vitro and in vivo studies.

The combination of Cum and Doc demonstrated superior anticancer efficacy with minimal toxicity to normal tissues, suggesting that adding Cum to traditional chemotherapy could be a promising strategy for treating lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic antitumor efficiency of docetaxel and curcumin against lung cancer. Yin, H., Guo, R., Xu, Y., et al.[2022]

A clinical trial involving 201 patients with osteoarthritis showed that both CuraMed® and Curamin® significantly reduced pain-related symptoms compared to a placebo after 12 weeks of treatment.

Curamin®, which combines curcumin with boswellic acid, demonstrated superior efficacy over CuraMed® alone, suggesting that the combination may enhance treatment outcomes due to synergistic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of curcumin and its combination with boswellic acid in osteoarthritis: a comparative, randomized, double-blind, placebo-controlled study. Haroyan, A., Mukuchyan, V., Mkrtchyan, N., et al.[2018]

In a study using a transgenic mouse model of lung cancer, dietary curcumin was found to increase tumor multiplicity and progression to later stage lesions, suggesting it may not be effective as a chemopreventive agent for lung cancer.

The research indicated that curcumin could enhance oxidative damage in lung tissue, particularly in smokers and ex-smokers, leading to the recommendation that ongoing clinical trials should consider excluding these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung tumor promotion by curcumin. Dance-Barnes, ST., Kock, ND., Moore, JE., et al.[2021]

Quercetin-decorated liposomes containing curcumin showed improved effectiveness in increasing the lifespan and body weight of mice with Dalton's ascites lymphoma compared to liposomes without quercetin, indicating enhanced therapeutic potential.

The study demonstrated that these liposomes, with a particle size of approximately 261.8 nm, not only improved the cytotoxicity against cancer cells (HT-29 and HCT-15) but also addressed curcumin's limitations like poor solubility and short biological half-life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. Ravichandiran, V., Masilamani, K., Senthilnathan, B., et al.[2018]

Citations

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Phase II Trial to Modulate Intermediate Endpoint Biomarkers in ... ... curcumin) can help reduce the size of lung nodules. Researchers also want to find out if the combination of Lovaza+Curcumin C3 Complex is safe and tolerable.

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Study Details | NCT03598309 | Phase II Trial to Modulate ... The purpose of this study is to find out if an investigational combination drug called Lovaza (made with fish oils)+Curcumin C3 Complex (made from a root called ...

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Fish Oil and Curcumin in Preventing Lung Nodules from ... This phase II trial studies how well fish oil and curcumin work in preventing lung nodules from growing larger in former and current smokers.

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Lovaza + Curcumin for Lung Nodule Reduction Trial Overview Researchers are testing if Lovaza (fish oil) combined with Curcumin C3 Complex can reduce the size of lung nodules in smokers. The safety and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2691137/

Lung tumor promotion by curcumin - PMC - PubMed Central Curcumin exhibits anti-inflammatory and antitumor activity and is being tested in clinical trials as a chemopreventive agent for colon cancer.

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OMACOR® Omega-3-acid ethyl esters, capsules Omacor® is indicated as an adjunct to diet to reduce very high (≥ 500 mg/dL) triglyceride (TG) levels in adult patients. Usage Considerations. According to ...

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