Safety Assessment of Lactobacillus Fermented Extract in Cancer Patients Undergoing Chemotherapy

NCT00606970 | Withdrawn Early Phase 1

• 3 other identifiers: Seigen Safety Trial: CancerWIRB Study No. 1085894WIRB Pr. No. 20062258
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Project: Assessment of the safety of dietary supplement lactobacillus fermented extract in cancer patients undergoing chemotherapy Nausea and vomiting are significant causes of nutritional depletion and result in further deterioration of the physical and mental status. Support of gastrointestinal function may alleviate nausea and vomiting from chemotherapy and will not only reduce the discomfort experienced by the patient but will allow better tolerance of the treatment. This study will assess orally administered Seigen alpha EV during chemotherapy for its safety and effects on the nutritional depletion deriving from the chemotherapy. It will also look at its effect on the immune system in patients undergoing chemotherapy.

Conditions

Cancer

Keywords

Chemotherapy; Breast Cancer; Colon Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Change in self-rated symptoms and assessed signs

  3 months

Secondary Outcomes (1)

• Affect on treatment results

  3 months maximum

Study Arms (2)

Intervention group

EXPERIMENTAL

Seigen Alpha EV Treatment

Dietary Supplement: Seigen Alpha EV

2

PLACEBO COMPARATOR

Identically packaged placebo packets taken 3x daily for 3 months maximum

Dietary Supplement: Placebo Comparator

Interventions

Seigen Alpha EV DIETARY_SUPPLEMENT

Orally administered Seigen Alpha EV, 1 packet (6 grams)3 times daily, for maximum of 3 months. Each packet is clearly marked for breakfast, lunch, or supper. The contents are to be dissolved in water or liquid and taken orally with meal. Subjects will be required to return any unused packets to study doctor at end of each month.

Also known as: Lactobacillus fermented extract

Intervention group

Placebo Comparator DIETARY_SUPPLEMENT

Identically packaged placebo packets (each 6 grams) taken 3x daily with meals for 3 months maximum.

Also known as: Placebo packaged identically to Seigen Alpha EV

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible subjects have given written informed consent prior to participation
• They must have a life expectancy of greater than 6 months
• They must have biopsy confirmed primary breast, colon or lung cancer
• They are receiving standard chemotherapy in accordance with American Society Clinical Oncology (ASCO) standards and have at least one month remaining in their chemotherapy course
• They must have an Eastern Cooperative Oncology Group (ECOG) performance status \< 2 and are being treated as outpatients.
• Subjects must be between the ages of 18 to 75 years of age.
• Subjects must be able to communicate in English.

You may not qualify if:

• Have received radiotherapy within the last 4 weeks
• Have acute gastrointestinal problems e.g. acute gastrointestinal infection, gastric or duodenal ulcer, history of bowel obstruction, diverticulitis, Crohn's disease, ulcerative colitis, or chronic diarrhea
• Presence or clinical evidence of CNS metastases
• Receiving corticosteroids
• Have severe concomitant disease
• Have severe dysphagia, esophagitis or xerostoma

Sponsors & Collaborators

• New Hope Medical Center: lead

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Colonic Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ed Fujimoto, PhD

  New Hope Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 7, 2013

Record last verified: 2013-05