Effects of Selected Vegetable and Herb Mix (SV) on Advanced Non-small Cell Lung Cancer

NCT00246727 | Unknown Phase 3 DMC

• 1 other identifier: SV-001 and SV-002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of these two studies is to test the hypothesis that the daily ingestion of a dietary supplement, Selected Vegetables and Herbs Mix (SV), which consists of non-toxic botanicals containing known anti-cancer and/or immune enhancing components, may prolong the survival time of stage IIIB/IV non-small cell lung cancer (NSCLC) patients. Either SV or placebo will be added to their daily diet in a double-blind randomized fashion, so that there will be 2 chances out of 3 of receiving SV and 1 chance out of 3 of receiving placebo.

• Study 1: For newly diagnosed patients who will be receiving or have received less than 4 weeks of, a standard chemotherapy regimen.
• Study 2: For those who have stopped or refuse standard chemotherapy but will receive best supportive care.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Survival Time

  Median Survival Time (MST)

Secondary Outcomes (3)

• Tumor response

  After one month of treatment

• Quality of Life

  For length of study while on active treatment

• Toxicity of SV

  Annually

Study Arms (2)

Study 1: Chemotherapy plus SV or Placebo

PLACEBO COMPARATOR

For newly diagnosed patients who will be receiving or have received less than 4 weeks of a standard chemotherapy regimen.

Drug: Selected Vegetable and Herb Mix

Study 2: SV vs Placebo without chemotherapy

PLACEBO COMPARATOR

For those who have stopped or refuse standard chemotherapy but will receive best supportive care.

Drug: Selected Vegetable and Herb Mix

Interventions

Selected Vegetable and Herb Mix DRUG

The phytomix consists of 19 vegetable and herbs in a highly concentrated form. These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities. Each batch of raw materials has gone through a very strict quality control (QC) scheme to make sure the product meets our QC standards and devoid of deleterious contaminations, such as heavy metals, pesticides, aflatoxin, and microorganisms. The manufacturing process is tightly controlled to ensure batch-to-batch consistency. The final product, a 20 gram freeze-dried powder, is sealed in a pouch. In our previous studies, patients who ingested phytomix daily for 17-60 months showed no clinical sign of adverse effect.

Study 1: Chemotherapy plus SV or Placebo; Study 2: SV vs Placebo without chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological and radiographic documented stage IIIB/IV NSCLC (squamous, adenocarcinoma, bronchioloalveolar, large cell, undifferentiated or not otherwise specified non-small cell carcinoma) diagnosed less than two months prior to randomization. Patients must have ECOG performance status of 0-1 and life expectancy \>3 months.
• Patients must never have been diagnosed with any malignancy other than the current NSCLC, except for non-metastatic non-melanoma skin cancer, or cancer in situ of the cervix.
• Patients must be \>18 years of age.
• Patients must demonstrate the ability and willingness to eat solid food and SV/placebo.
• Patients must demonstrate the ability and willingness to give informed consent.
• Patients must demonstrate the ability and willingness to follow the study requirements.

You may not qualify if:

• Liver function: bilirubin \> 1.5x upper limit of normal (ULN) and SGOT (AST) \> 2.5x ULN.
• Renal function: Serum creatinine \>1.5x ULN
• Bone marrow function: white blood cell (WBC) \< 4,000/µl; platelet count \< 100,000 mm3; neutrophil count \< 1,500/mm3.
• Hemoglobin \<9 gm/dl for males; \< 8.5 gm/dl for females.
• Unexplained temperature \> 38.5° C for any 7 consecutive days or chronic diarrhea defined as \> 3 stools/day persisting for 15 consecutive days, within the 30 days prior to randomization.
• Prior chemotherapy within 5 years.
• Prior radiation to the area of measurable or active tumor.
• Significant cardiac disease (i.e. uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous year) or serious cardiac arrhythmia requiring medication.
• Evidence of clinically significant neuropathy (\> Grade 1) by physical exam.
• Patients must not be pregnant or breast-feeding. Female patients of child-bearing potential must have a negative pregnancy test performed within 72 hours prior to randomization. Women of child-bearing potential must agree not to become pregnant while participating in the study.
• Active acute infection, except for Herpes viruses (cytomegalovirus \[CMV\], Epstein Barr virus \[EBV\], herpes zoster virus \[HZV\], herpes simplex virus 1 \[HSV 1\]).
• A serious underlying medical condition other than NSCLC such that life expectancy is less than 2 years.
• Psychiatric illness that may affect the patient's compliance with the treatment.
• Current use of illicit drugs, glucocorticoids other than those necessary for concurrent radiotherapy, adrenal failure or septic shock, or other immune-suppressing or immune-modulating drugs. Glucocorticoids for anti-emetic prophylaxis and therapy should only be used as a last resort.
• A known allergy to one or more components of SV, namely soy beans, mushrooms, mung beans, red dates, scallion, garlic, lentil beans, leek, hawthorn fruit, onions, ginseng, angelica root, Chinese licorice, dandelion root, Senegal root, ginger, olives, sesame seed and parsley.

Sponsors & Collaborators

• Sun Farm Corporation: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Henry S Sacks, MD, Ph.D

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry Sacks, MD, Ph.D

CONTACT

212-241-7856; henry.sacks@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2014
• Last Updated: October 31, 2011

Record last verified: 2011-10

Locations

US (1)