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Cancer Vaccine
Botanical Supplement for Lung Cancer
Phase 3
Waitlist Available
Led By Henry S Sacks, MD, Ph.D
Research Sponsored by Sun Farm Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0-1
Ability and willingness to eat solid food and SV/placebo
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after one month of treatment
Awards & highlights
Study Summary
This trial is testing whether a dietary supplement consisting of botanicals with known anti-cancer and/or immune-enhancing properties can prolong the survival time of stage IIIB/IV non-small cell lung cancer patients. The supplement will be given to patients in a double-blind fashion, meaning that neither the patients nor the trial staff will know who is receiving the supplement and who is receiving a placebo.
Who is the study for?
Adults over 18 with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) who can eat solid food and follow study guidelines. They must not have had other cancers except certain skin or cervical cancers, be in good physical condition, and not pregnant. Excluded if they have significant liver, kidney, bone marrow issues, severe neuropathy or infections, heart disease within a year, drug abuse history or are on immune-suppressing drugs.Check my eligibility
What is being tested?
The trial is testing whether a dietary supplement made of vegetables and herbs called Selected Vegetables and Herbs Mix (SV) can extend the lives of patients with late-stage NSCLC. Participants will either receive SV or a placebo alongside their normal diet in a double-blind study where neither they nor the researchers know who gets what until after the trial.See study design
What are the potential side effects?
Since SV is composed of various natural ingredients like soybeans and ginseng among others, potential side effects may include allergic reactions to any component in the mix. However specific side effects are not listed as it's presumed to be non-toxic.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I can eat solid food and take the study drug or placebo.
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I am willing and able to give my consent.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after one month of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after one month of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival Time
Secondary outcome measures
Quality of Life
Toxicity of SV
Tumor response
Trial Design
2Treatment groups
Placebo Group
Group I: Study 1: Chemotherapy plus SV or PlaceboPlacebo Group1 Intervention
For newly diagnosed patients who will be receiving or have received less than 4 weeks of a standard chemotherapy regimen.
Group II: Study 2: SV vs Placebo without chemotherapyPlacebo Group1 Intervention
For those who have stopped or refuse standard chemotherapy but will receive best supportive care.
Find a Location
Who is running the clinical trial?
Sun Farm CorporationLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,633 Total Patients Enrolled
Henry S Sacks, MD, Ph.DPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have not had chemotherapy in the last 5 years.I have had radiation therapy on the tumor that can be measured or is active.My lung cancer was diagnosed as stage IIIB/IV less than two months ago.I've had a fever over 38.5°C for a week or chronic diarrhea for 15 days in the last month.My hemoglobin level is below the normal range for my gender.I can eat solid food and take the study drug or placebo.I am willing and able to give my consent.My liver tests are within normal limits.My kidney function is reduced, with creatinine levels above normal.I am older than 18 years.I have only been diagnosed with NSCLC, except for non-spreading skin cancer or cervical pre-cancer.I am willing and able to follow the study's requirements.I do not have serious heart conditions like uncontrolled high blood pressure, recent heart attacks, or severe heart rhythm problems.I do not have severe nerve damage.I am not pregnant or breastfeeding and agree to prevent pregnancy during the study.I do not have any active infections, except for common herpes viruses.I have a serious health condition that may limit my life to under 2 years, not including my lung cancer.I am not currently using illicit drugs or immune-suppressing medications, except possibly for necessary treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Study 1: Chemotherapy plus SV or Placebo
- Group 2: Study 2: SV vs Placebo without chemotherapy
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this remedy carry a lot of risk for patients?
"This therapeutic intervention is classified as a Phase 3 trial, meaning that while there is some evidence affirming its efficacy, there is also extensive data supporting its safety. Our analysts have rated the safety of this treatment as a 3."
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