Boswellia Serrata Extract in Treating Patients with Ductal Breast Carcinoma In Situ, Stage I-III Breast Cancer, or Stage I-III Colon Cancer That Are Undergoing Surgery

Status: Active

Description

This phase I trial studies how well Boswellia serrata extract works in treating patients with ductal breast carcinoma in situ, stage I-III breast cancer, or stage I-III colon cancer that are undergoing surgery. Boswellia serrata extract is a supplement made from the Boswellia serrata plant, which helps to reduce inflammation in the body, and may change the make up of the tumors of patients who have breast and colon cancer.

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed ductal carcinoma in situ (DCIS) or invasive breast cancer (stages I, II, or III) with primary tumor(s) >= 1.0 cm on mammogram, ultrasound, magnetic resonance imaging (MRI), or physical exam or histologically confirmed adenocarcinoma of the colon, stages I, II or III with primary tumor >= 1cm visualized by colonoscopy
  • Subject must understand risks and benefits of the protocol and be able to give informed consent
  • Women of child-bearing potential (WOCBP) must agree to use an approved form of birth control and to have a negative pregnancy test result before registration; WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; approved forms of birth control: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) * Progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) * Intrauterine device, intrauterine hormone-releasing system * Bilateral tubal occlusion/ligation * Vasectomized partner * Barrier contraception * Sexual abstinence
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Within 14 days prior to registration: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Within 14 days prior to registration: Platelet count >= 100 x 10^9/L
  • Within 14 days prior to registration: Hemoglobin >= 9 g/dL
  • Within 14 days prior to registration: Albumin >= 2.5 g/dL
  • Within 14 days prior to registration: Bilirubin =< 1.5 x the upper limit of normal (ULN)
  • Within 14 days prior to registration: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), =< 3 x ULN
  • Within 14 days prior to registration: Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockcroft-Gault glomerular filtration rate estimation
  • Ability and capacity to comply with the study and follow-up procedures
  • Subjects must be scheduled for surgery at Medical University of South Carolina (MUSC) no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day 1
  • For breast cancer patients, at least 6 sections of unstained slides should be obtained; if sufficient slides or tissue is unavailable, the patient will be excluded from the trial; for colon cancer patients, confirmation of tissue availability is not required, but documentation that the block is available must be provided to confirm eligibility

Exclusion Criteria

  • Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy
  • Subjects with end-stage kidney disease and/or grade II liver dysfunction
  • Subject has active or history of deep vein thrombosis (DVT)
  • Subject has a history of coagulopathies or hematological disorders
  • Subjects who are pregnant or are lactating
  • Subjects already taking drugs known to be 5-lipoxygenase inhibitors
  • Subjects taking drugs that interact with OATP1B3 (an anion transporter), MRP2 (a multidrug resistant protein), and/or P-glycoprotein (P-Gp)
  • Subjects taking anti-coagulants or platelet inhibitors
  • Subjects with bowel obstruction
  • Subjects undergoing emergency surgery

Locations & Contacts

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Nancy DeMore
Phone: 843-876-0179
Email: demore@musc.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine whether oral administration of Boswellia serrata extract (Boswellia serrata) causes biological changes related to angiogenesis (CD31), apoptosis (deoxyribonucleic acid [DNA] fragmentation), and cell proliferation (Ki67) in primary tumors of breast or colon cancer patients.

SECONDARY OBJECTIVES:

I. To determine the safety and toxicity of oral Boswellia serrata extract in patients with breast or colon cancer.

II. To explore other potential biomarkers involved in tumor proliferation and tumor microenvironment.

OUTLINE:

Patients receive Boswellia serrata extract orally (PO) three times daily (TID) for up to 56 days or until the day of surgery, whichever comes first, in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1-4 weeks.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Medical University of South Carolina

Principal Investigator
Nancy DeMore

Trial IDs

Primary ID 102688
Secondary IDs NCI-2017-01671
Clinicaltrials.gov ID NCT03149081