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

19 Participants Needed

Trial Summary

What is the purpose of this trial?

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 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.

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.

What evidence supports the effectiveness of the drug Lovaza + Curcumin for lung nodule reduction?

Curcumin, a component of the treatment, has shown potential in reducing inflammation and has been studied for its effects on lung cancer, suggesting it might help with lung-related conditions. However, most evidence comes from laboratory or animal studies, and its effectiveness in humans, especially for lung nodules, is not well-established. ^{1 2 3 4 5}

Is the combination of Lovaza and Curcumin generally safe for humans?

Curcumin is considered generally safe by the US FDA, but it may increase lung tumor growth and inflammation in certain conditions, particularly in smokers or ex-smokers. Additionally, curcumin has shown little toxicity to normal tissues in combination with other treatments in some studies. ^{6 7 8 9 10}

How is the drug Lovaza + Curcumin unique for lung nodule reduction?

The combination of Lovaza (an omega-3 fatty acid) and Curcumin (a compound from turmeric) is unique because it targets lung nodules with both anti-inflammatory and potential anti-tumor effects, leveraging Curcumin's ability to affect cancer cell pathways and enhance chemotherapy, while Lovaza may support overall health with its omega-3 content. ^{2 5 8 9 11}

Research Team

Nagi Kumar, PhD

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Curcumin use in pulmonary diseases: State of the art and future perspectives. [2018]

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

Versatile role of curcumin and its derivatives in lung cancer therapy. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Curcumin: An age-old anti-inflammatory and anti-neoplastic agent. [2023]

4. England 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. [2018]

5. United States 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. [2022]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. [2018]

7. England 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. [2019]

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

Curcumin as an inhibitor of cancer. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Lung tumor promotion by curcumin. [2021]

10. China pubmed.ncbi.nlm.nih.gov

Synergistic antitumor efficiency of docetaxel and curcumin against lung cancer. [2022]

11. Poland pubmed.ncbi.nlm.nih.gov

[Preventive role of curcumin in lung cancer]. [2013]