CLINICAL TRIAL

leucoselect phytosome for Lung Cancer

Stage I
Waitlist Available · 18+ · All Sexes · Albuquerque, NM

This study is evaluating whether a special formulation of a grape seed extract may help prevent lung cancer.

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About the trial for Lung Cancer

Eligible Conditions
Lung Neoplasms · Early Stage Lung Cancer (I and II)

Treatment Groups

This trial involves 2 different treatments. Leucoselect Phytosome is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
leucoselect phytosome
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Lesions suspicious for lung cancer
Competent to provide consent
A CBC should be within normal limits for an individual. show original
The liver function test is within normal limits. show original
underestimates true creatinine clearance in patients with chronic kidney disease show original
The patient's performance status is good: 0-1. show original
Histologically proven and surgically resectable clinical I and II stage NSCLC
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2
Screening: ~3 weeks
Treatment: Varies
Reporting: Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether leucoselect phytosome will improve 1 primary outcome, 3 secondary outcomes, and 12 other outcomes in patients with Lung Cancer. Measurement will happen over the course of No greater than 14 days delay in planned surgery..

Delay in the planned surgery of >14 days that is possibly related to study medication (Safety and feasibility).
NO GREATER THAN 14 DAYS DELAY IN PLANNED SURGERY.
Defined as no delay in the planned surgery of >14 days that is possibly related to study medication.
NO GREATER THAN 14 DAYS DELAY IN PLANNED SURGERY.
PGI2.
INTERIM ANALYSIS ON MATCHED, PRE- AND POST-TREATMENT COMPARISONS WILL BE PERFORMED AFTER 10 SUBJECTS HAVE COMPLETED THE TREATMENT PORTION OF THE STUDY, ANTICIPATED TO BE IN YEAR 2
Modulations of this marker of inflammation and immunity in biospecimens.
INTERIM ANALYSIS ON MATCHED, PRE- AND POST-TREATMENT COMPARISONS WILL BE PERFORMED AFTER 10 SUBJECTS HAVE COMPLETED THE TREATMENT PORTION OF THE STUDY, ANTICIPATED TO BE IN YEAR 2
MicroRNA (miR)-19a
INTERIM ANALYSIS ON MATCHED, PRE- AND POST-TREATMENT COMPARISONS WILL BE PERFORMED AFTER 10 SUBJECTS HAVE COMPLETED THE TREATMENT PORTION OF THE STUDY, ANTICIPATED TO BE IN YEAR 2
Modulations of this oncogenic miRNA in serum and tumors.
INTERIM ANALYSIS ON MATCHED, PRE- AND POST-TREATMENT COMPARISONS WILL BE PERFORMED AFTER 10 SUBJECTS HAVE COMPLETED THE TREATMENT PORTION OF THE STUDY, ANTICIPATED TO BE IN YEAR 2
Stage of lung cancer
INTERIM ANALYSIS ON MATCHED, PRE- AND POST-TREATMENT COMPARISONS WILL BE PERFORMED AFTER 10 SUBJECTS HAVE COMPLETED THE TREATMENT PORTION OF THE STUDY, ANTICIPATED TO BE IN YEAR 2
Change of lung cancer stage based on the American Joint Committee on Cancer (AJCC) TNM staging system.
INTERIM ANALYSIS ON MATCHED, PRE- AND POST-TREATMENT COMPARISONS WILL BE PERFORMED AFTER 10 SUBJECTS HAVE COMPLETED THE TREATMENT PORTION OF THE STUDY, ANTICIPATED TO BE IN YEAR 2
Tumor activated caspase 3.
INTERIM ANALYSIS ON MATCHED, PRE- AND POST-TREATMENT COMPARISONS WILL BE PERFORMED AFTER 10 SUBJECTS HAVE COMPLETED THE TREATMENT PORTION OF THE STUDY, ANTICIPATED TO BE IN YEAR 2
Modulations of this marker of apoptosis in tumors.
INTERIM ANALYSIS ON MATCHED, PRE- AND POST-TREATMENT COMPARISONS WILL BE PERFORMED AFTER 10 SUBJECTS HAVE COMPLETED THE TREATMENT PORTION OF THE STUDY, ANTICIPATED TO BE IN YEAR 2
IL-6.
INTERIM ANALYSIS ON MATCHED, PRE- AND POST-TREATMENT COMPARISONS WILL BE PERFORMED AFTER 10 SUBJECTS HAVE COMPLETED THE TREATMENT PORTION OF THE STUDY, ANTICIPATED TO BE IN YEAR 2
Modulations of this marker of inflammation and immunity in biospecimens.
INTERIM ANALYSIS ON MATCHED, PRE- AND POST-TREATMENT COMPARISONS WILL BE PERFORMED AFTER 10 SUBJECTS HAVE COMPLETED THE TREATMENT PORTION OF THE STUDY, ANTICIPATED TO BE IN YEAR 2
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for lung cancer?

Different treatment types are often used, even for patients with the same clinical stage. Common treatment options for lung cancer include surgery, chemotherapy, radiation therapy, targeted treatment, and a combination of these.

Anonymous Patient Answer

Can lung cancer be cured?

Lung cancer cannot be cured. As long as lung cancer continues to cause death, as a result of metastasis, curative treatment is impossible. However, lung cancer treatment may be improved. Some people may have remission of symptoms.

Anonymous Patient Answer

How many people get lung cancer a year in the United States?

Around 50 million Americans develop [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) each year, making lung cancer the most frequent cancer in US men. Approximately 20% of lung cancer deaths and 30% of lung cancer-related death in the United States occur to people with lung cancer.

Anonymous Patient Answer

What is lung cancer?

Lung cancer is a malignancy of the lung. Lung cancer is the most common form of cancer affecting adults and is the most costly form of cancer in terms of lifetime costs. Smoking is often associated with the disease, and a number of other risk factors are being studied.

Anonymous Patient Answer

What are the signs of lung cancer?

Pain, in one or both sides of the chest, is the most common symptom of lung cancer. In severe cases, it could be associated with breathlessness or hemoptysis.\n

Anonymous Patient Answer

What causes lung cancer?

There is a lot of information available about lung cancer risk factors. The main one which leads to the largest percentage of people dying from lung cancer is cigarette smoking. It is not only the number of cigarettes that causes lung cancer, but the length of time that a person have been smoking, for example, 5 pack-years with a 30 pack-year history. Smoking is the strongest and most prevalent risk factor for lung cancer. Even though less than 5 percent of lung cancer cases are caused by passive smoking, such as secondhand smoke in the home and workplace, research conducted shows an association between exposure to secondhand smoke and lung cancer risk. There is also a relationship between passive smoking and emphysema and COPD.

Anonymous Patient Answer

Has leucoselect phytosome proven to be more effective than a placebo?

Results from a recent paper indicates no superiority of leucoselect phytosome over placebo tablets in reduction of pain and swelling rate. However, a possible clinical effect of leucoselect phytosome was evident in reduction of inflammation which may have led to pain and swelling in a quarter of patients.

Anonymous Patient Answer

How quickly does lung cancer spread?

Within the first two years following diagnosis, the tumor is almost always in localized or pT1. The likelihood of metastasis is highest at 4-6 months and decreases at 12 months. The chance of local/distant recurrence at 1 year is highest for T1b, whereas for nodular (pT2) lung cancer, the risk of recurrence is lowest.

Anonymous Patient Answer

What is leucoselect phytosome?

Although it is still hard to prove these claims, these results are encouraging: a product that may potentially help women with breast cancer to avoid chemotherapy-induced ovarian damage and menopausal symptoms by keeping estrogen levels, and possibly also preventing premature menopause in some patients, at a reasonable profit.

Anonymous Patient Answer

Is leucoselect phytosome typically used in combination with any other treatments?

The addition of phytosome in combination with other cancer treatments significantly (p < 0.01) reduced the number of patients who developed CIN 2/3 in comparison to placebo-treated patients. No significant difference was observed in terms of the progression rate, which were the primary outcome measures. No statistically significant difference (p = 0.10) was noticed in the median times to progression/recurrence or progression/recurrence/death of the treated patients compared with the placebo-treated group.

Anonymous Patient Answer

Is leucoselect phytosome safe for people?

The phytosome-containing products are safe and well tolerated by healthy adults. Both the single and repeated administration of phytosome-containing products resulted in the reduction (≥80%) of the phytosome-induced erythema and skin swelling in healthy adults in a 7 days study.

Anonymous Patient Answer

What is the average age someone gets lung cancer?

Approximately 1 of 19 men and 1 of 44 women has lung cancer by age 65, and the average age at the time of diagnosis is between 56 and 57 years. This age range is broader than what has previously been reported. These data suggest that lung cancer is more common in this age range worldwide than previously assumed and warrant consideration of screening this group with lung cancer.

Anonymous Patient Answer
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