Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer

July 9, 2018 updated by: Midwestern Regional Medical Center

A Comparison Study to Assess the Value of Naturopathic Medicine Given Immediately and Continuously or Delayed Until Cycle 3 in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer

This study is examine the effect of the addition of naturopathic on immunologic and/or inflammatory parameters and/or quality of life in women receiving neoadjuvant chemotherapy for breast cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  • Biopsy proven diagnosis of invasive adenocarcinoma of the breast
  • Recommendation for neoadjuvant chemotherapy.
  • Left Ventricular Ejection Fraction (LVEF) assessment by multigated acquisition scan or echocardiogram within 3 months of entering study
  • Blood counts:
  • Absolute Neutrophil Count ≥1200 cells/mm^3
  • Platelet count ≥100,000/mm^3
  • Hemoglobin ≥10g/dL
  • Serum creatinine ≤ Upper Limit of Normal (ULN) for the laboratory range
  • Total bilirubin ≤ ULN for the laboratory range, unless the patient has an elevation >ULN to 1.5 times the ULN resulting from Gilbert's disease or similar syndrome
  • Alkaline phosphatase less than or equal to 2.5 x ULN; and
  • Aspartate aminotransferase (AST) less than or equal to 1.5 x ULN for the laboratory range
  • If skeletal pain present or alkaline phosphatase >ULN (but less than or equal to 2.5x ULN), bone scan or Positron Emission Tomography (PET) scan must not demonstrate metastatic disease
  • AST or alkaline phosphatase greater than ULN, no metastatic disease liver identified by CT, MRI or PET scan
  • Able to swallow oral medication
  • Willing to forego naturopathic treatment for the first 2 treatment cycles
  • Willing to start and continue naturopathic interventions as prescribed
  • Willing to forego the use of nutritional or botanical supplements during the study

Exclusion Criteria:

  • Stage 4 disease
  • Present treatment with Warfarin.
  • Synchronous bilateral invasive breast cancer
  • Treatment including radiation, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to entering study
  • Any sex hormonal therapy e.g. birth control, ovarian hormone replacement therapy, etc. during participation in the study)
  • Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators
  • Prior history of breast cancer, including Ductal Carcinoma In Situ (subjects with a history of Lobular Carcinoma In Situ are eligible)
  • Prior therapy with chemotherapy or targeted therapy agents for any malignancy
  • Cardiac disease that would preclude the use of the certain drugs. This includes but is not confined to:
  • Active cardiac disease
  • Angina pectoris requiring treatment
  • Ventricular arrhythmias except controlled benign premature ventricular contractions
  • Conduction abnormality requiring a pacemaker
  • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled by medication
  • Clinical significant valvular disease
  • History of cardiac disease
  • Myocardial infarction
  • Congestive heart failure
  • Cardiomyopathy
  • Uncontrolled hypertension, (blood pressure above 150/90 mm/Hg on antihypertensive treatment)
  • History or current symptomatic interstitial pneumonitis or pulmonary fibrosis
  • Sensory/motor neuropathy ≥ grade 2
  • Malabsorption syndrome, ulcerative colitis, resection the stomach or small bowel, or other disease significantly affecting gastrointestinal function
  • Other non-malignant systemic disease precluding treatment with study regimens or required follow up
  • Contraindication of corticosteroids
  • Administration of an investigational agent within 30 days prior to entering study.
  • Administration of therapeutic doses of the supplements being studied including maitake, melatonin and Coenzyme Q10 in the previous 30 days.
  • Administration of therapeutic doses of immune modulating botanicals in the previous 30 days.
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Immediate and Continuous Dosing
Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.
Biological: Reishi mushroom extract
Reishi mushroom preparation produced water-ethanol extraction.
Other Names:
  • Ganoderma lucidum
Drug: Coenzyme Q10
Preparation of coenzyme Q10
Other Names:
  • Ubiquinone
  • Ubidecarenone
Drug: Melatonin
Preparation of melatonin
Other Names:
  • N-acetyl-5-methoxy tryptamine
Active Comparator: Delayed Dosing
Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy.
Biological: Reishi mushroom extract
Reishi mushroom preparation produced water-ethanol extraction.
Other Names:
  • Ganoderma lucidum
Drug: Coenzyme Q10
Preparation of coenzyme Q10
Other Names:
  • Ubiquinone
  • Ubidecarenone
Drug: Melatonin
Preparation of melatonin
Other Names:
  • N-acetyl-5-methoxy tryptamine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Subject Reported Quality of Life Score
Time Frame: Initial visit and study visits at 3-week intervals up to 4 months
Subject quality of life as measured by a self-administered questionnaire (0 to 10 Likert scale with 0=No Effect to 10=Worst Effect) at each study visit. The symptoms or impact on activities scored included: Pain, Fatigue, Nausea, Sleep Disturbance, Distress, Shortness of Breath, Memory/Recall Problems, Appetite, Drowsiness, Dry Mouth, Sadness, Vomiting, Numbness, General Activities, Mood, Work, Relationships, Walking or Enjoyment.
Initial visit and study visits at 3-week intervals up to 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentration of C-reactive Protein in Serum (mg/L)
Time Frame: Initial visit and study visits at 3-week intervals up to 4 months
The serum concentration of C-reactive protein will be measured by approved methods.
Initial visit and study visits at 3-week intervals up to 4 months
Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter)
Time Frame: Initial visit and study visits at 3-week intervals up to 4 months
The serum concentration of circulating tumor cells will be measured by approved methods.
Initial visit and study visits at 3-week intervals up to 4 months
Sedimentation Rate of Erythrocytes in Blood (mm/hr)
Time Frame: Initial visit and study visits at 3-week intervals up to 4 months
The erythrocyte sedimentation rate will be measured by approved methods.
Initial visit and study visits at 3-week intervals up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Midwestern Regional Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christina Shannon, ND, Midwestern Regional Medical Center, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 3, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MZ2014018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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