What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as tamoxifen and aromatase inhibitors, have distinct side effect profiles. Tamoxifen can cause hot flashes, vaginal dryness, and an increased risk of blood clots and endometrial cancer. Aromatase inhibitors, like anastrozole, may lead to loss of bone density, fractures, and cardiovascular risks. Chemotherapy often results in nausea, hair loss, fatigue, and an increased risk of infections due to lowered white blood cell counts. Radiation therapy can cause skin irritation, fatigue, and, in some cases, long-term heart and lung issues. These side effects should be discussed with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer, including targeted therapies and immunotherapies. Notable approvals include trastuzumab deruxtecan and trastuzumab emtansine, both of which are used for HER2-positive metastatic breast cancer. Trastuzumab deruxtecan is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells, while trastuzumab emtansine combines trastuzumab with a cytotoxic agent. These treatments exemplify the targeted approach that may be similar to the mechanisms being studied in the N-111 trial.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include targeted therapies such as CDK4/6 inhibitors, PI3K inhibitors, and novel compounds under study aimed at overcoming resistance in HR+ and HER2-negative breast cancer. These therapies focus on specific molecular targets and pathways involved in cancer progression, offering personalized treatment options.

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Dietary Supplement

Diet + N-111 Supplement for Cancer

Phase 1

Waitlist Available

Research Sponsored by Optimal Health Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers

Prostate cancer as determined by a Transrectal Biopsy with associated Prostate-specific antigen blood work

Must not have

Patients without the positive diagnosis of breast or prostate cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of month 3.

Summary

This trial is testing a cancer medication called N-111. It aims to find out if following a vegetarian or non-vegetarian diet affects how well the medication works in cancer patients. The study will compare these diets over a period of time.

Who is the study for?

This trial is for individuals with a confirmed diagnosis of breast cancer via Fine Needle Biopsy or open biopsy and specific blood markers, or prostate cancer confirmed by Transrectal Biopsy with certain blood work. It's not open to those without these specific diagnoses.

What is being tested?

The study examines the effects of two different diets on the treatment outcomes in patients taking N-111, a dietary supplement. Participants will either receive this supplement or a placebo to see which diet works better.

What are the potential side effects?

Since this trial involves dietary supplements rather than drugs, side effects may be minimal but could include digestive discomfort or allergic reactions depending on individual sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with breast cancer through a biopsy.

Select...

My prostate cancer was confirmed by a biopsy and PSA blood test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have breast or prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of month 3.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of month 3.

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of month 3. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Active Comparator: Non-vegetarian N-111 group.

Active Comparator: Vegetarian N-111 group

Secondary study objectives

Placebo Comparator: Non-vegetarian placebo control group

Placebo Comparator: Vegetarian placebo group

Trial Design

6Treatment groups

Active Control

Placebo Group

Group I: Vegetarian control groupActive Control1 Intervention

The group will use a vegetarian diet without the active compactor N-111 or the placebo.

Group II: Non-vegetarian control groupActive Control1 Intervention

he group will use a non-vegetarian diet without the active compactor N-111 or the placebo.

Group III: Non-vegetarian N-111 group.Active Control1 Intervention

The group will use a non-vegetarian diet with the active compactor N-111.

Group IV: Vegetarian N-111 groupActive Control1 Intervention

The group will use a vegetarian diet with the active compactor N-111.

Group V: Non-vegetarian placebo control groupPlacebo Group1 Intervention

The group will use a non-vegetarian diet with a placebo.

Group VI: Vegetarian placebo groupPlacebo Group1 Intervention

The group will use a vegetarian diet with a placebo.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include CDK4/6 inhibitors, HER2-targeted therapies, and hormonal therapies. CDK4/6 inhibitors, such as palbociclib, work by blocking proteins that promote cell division, thereby slowing cancer growth. HER2-targeted therapies, like trastuzumab, bind to the HER2 receptor on cancer cells, inhibiting their growth and survival. Hormonal therapies, such as tamoxifen, block hormones like estrogen that can fuel certain types of breast cancer. Understanding these mechanisms is crucial for breast cancer patients as it helps in selecting the most effective treatment, managing resistance, and improving overall outcomes.

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