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

• Sponsor: Midwestern Regional Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02486796
• Collaborator: (none)
• Enrollment: 5
• Arms: 2
• Actual Duration (Months): 12.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life	Biological: Reishi mushroom extract; Drug: Coenzyme Q10; Drug: Melatonin	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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
• Actual Study Start Date: Feb 19, 2016
• Actual Primary Completion Date: Mar 3, 2017
• Actual Study Completion Date: Mar 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Subject Reported Quality of Life Score [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.

Secondary Outcome Measures

1. Concentration of C-reactive Protein in Serum (mg/L) [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.

2. Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter) [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.

3. Sedimentation Rate of Erythrocytes in Blood (mm/hr) [Initial visit and study visits at 3-week intervals up to 4 months]

   The erythrocyte sedimentation rate will be measured by approved methods.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Midwestern Regional Medical Center

Investigators

• Principal Investigator: Christina Shannon, ND, Midwestern Regional Medical Center, Inc.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Nov 11, 2015

More Information

Publications

None provided.

• Responsible Party: Midwestern Regional Medical Center
• ClinicalTrials.gov Identifier: NCT02486796
• Other Study ID Numbers: MZ2014018
• First Posted: Jul 1, 2015
• Last Update Posted: Aug 1, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ubiquinone; Coenzyme Q10; Melatonin

Study Results

Participant Flow

Arm/Group Title	Immediate and Continuous Dosing	Delayed Dosing
Arm/Group Description	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin
Period Title: Overall Study
STARTED	3	2
COMPLETED	1	1
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Immediate and Continuous Dosing	Delayed Dosing	Total
Arm/Group Description	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin	Total of all reporting groups
Overall Participants	3	2	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	2 100%	5 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	3 100%	2 100%	5 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	3 100%	2 100%	5 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	3 100%	2 100%	5 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	3 100%	2 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Subject Reported Quality of Life Score
Description	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.
Time Frame	Initial visit and study visits at 3-week intervals up to 4 months

Outcome Measure Data

Analysis Population Description

One subject in the 'Delayed' arm withdrew consent following Study Visit 2. One subject in the 'Immediate' arm did not complete the Quality of Life Questionnaire at Visit 2. One subject in the 'Delayed' arm did not complete the Quality of Life Questionnaire at Visit 5. One subject in the 'Immediate' Arm withdrew consent prior to completing Visit 5.

Arm/Group Title	Immediate and Continuous Dosing	Delayed Dosing
Arm/Group Description	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin
Measure Participants	3	2
Worst Pain (Visit 1)	0.7 (0.9)	2.0 (1.0)
Worst pain (Visit 2)	1.0 (1.0)	1.0 (0.0)
Worst Pain (Visit 3)	0.7 (0.9)	2.0 (0.0)
Worst Pain (Visit 4)	0.5 (0.5)	1.0 (0.0)
Worst Pain (Visit 5)	1.0 (0.0)
Worst Fatigue (Visit 1)	1.0 (0.8)	1.5 (0.5)
Worst Fatigue (Visit 2)	1.0 (1.0)	3.5 (1.5)
Worst Fatigue (Visit 3)	1.3 (1.2)	3.0 (0.0)
Worst Fatigue (Visit 4)	1.5 (0.5)	1.0 (0.0)
Worst Fatigue (Visit 5)	1.0 (0.0)
Worst Nausea (Visit 1)	0.7 (0.9)	0.0 (0.0)
Worst Nausea (Visit 2)	0.0 (0.0)	1.0 (0.0)
Worst Nausea (Visit 3)	0.3 (0.5)	1.0 (0.0)
Worst Nausea (Visit 4)	0.5 (0.5)	0.0 (0.0)
Worst Nausea (Visit 5)	3.0 (0.0)
Worst Sleep Disturbance (Visit 1)	3.3 (0.9)	3.0 (1.0)
Worst Sleep Disturbance (Visit 2)	0.5 (0.5)	1.0 (1.0)
Worst Sleep Disturbance (Visit 3)	1.7 (0.5)	1.0 (0.0)
Worst Sleep Disturbance (Visit 4)	1.0 (0.0)	0.0 (0.0)
Worst Sleep Disturbance (Visit 5)	3.0 (0.0)
Worst Sleep Distress (Visit 1)	2.3 (1.2)	1.0 (0.0)
Worst Sleep Distress (Visit 2)	0.5 (0.5)	1.0 (1.0)
Worst Sleep Distress (Visit 3)	1.0 (0.8)	0.0 (0.0)
Worst Sleep Distress (Visit 4)	0.0 (0.0)	0.0 (0.0)
Worst Sleep Distress (Visit 5)	3.0 (0.0)
Worst Shortness of Breath (Visit 1)	0.0 (0.0)	0.0 (0.0)
Worst Shortness of Breath (Visit 2)	0.0 (0.0)	0.0 (0.0)
Worst Shortness of Breath (Visit 3)	0.0 (0.0)	2.0 (0.0)
Worst Shortness of Breath (Visit 4)	0.0 (0.0)	0.0 (0.0)
Worst Shortness of Breath (Visit 5)	0.0 (0.0)
Worst Memory/Recall (Visit 1)	0.7 (0.9)	2.5 (1.5)
Worst Memory/Recall (Visit 2)	0.5 (0.5)	1.0 (0.0)
Worst Memory/Recall (Visit 3)	1.0 (0.8)	2.0 (0.0)
Worst Memory/Recall (Visit 4)	0.5 (0.5)	3.0 (0.0)
Worst Memory/Recall (Visit 5)	2.0 (0.0)
Worst Appetite (Visit 1)	0.7 (0.5)	1.5 (1.5)
Worst Appetite (Visit 2)	1.0 (1.0)	1.5 (1.5)
Worst Appetite (Visit 3)	2.0 (2.8)	0.0 (0.0)
Worst Appetite (Visit 4)	.05 (.05)	0.0 (0.0)
Worst Appetite (Visit 5)	2.0 (0.0)
Worst Drowsiness (Visit 1)	1.0 (0.8)	1.5 (0.5)
Worst Drowsiness (Visit 2)	1.0 (1.0)	2.5 (1.5)
Worst Drowsiness (Visit 3)	1.0 (0.8)	3.0 (0.0)
Worst Drowsiness (Visit 4)	1.0 (0.0)	1.0 (0.0)
Worst Drowsiness (Visit 5)	1.0 (0.0)
Worst Dry Mouth (Visit 1)	0.0 (0.0)	0.5 (0.5)
Worst Dry Mouth (Visit 2)	0.5 (0.5)	1.5 (1.5)
Worst Dry Mouth (Visit 3)	0.7 (0.9)	0.0 (0.0)
Worst Dry Mouth (Visit 4)	0.5 (0.5)	0.0 (0.0)
Worst Dry Mouth (Visit 15	1.0 (0.0)
Worst Sadness (Visit 1)	1.3 (1.2)	1.5 (1.5)
Worst Sadness (Visit 2)	0.0 (0.0)	1.5 (1.5)
Worst Sadness (Visit 3)	0.3 (0.5)	0.0 (0.0)
Worst Sadness (Visit 4)	0.0 (0.0)	0.0 (0.0)
Worst Sadness (Visit 5)	2.0 (0.0)
Worst Vomiting (Visit 1)	0.0 (0.0)	0.0 (0.0)
Worst Vomiting (Visit 2)	0.0 (0.0)	0.0 (0.0)
Worst Vomiting (Visit 3)	0.0 (0.0)	0.0 (0.0)
Worst Vomiting (Visit 4)	0.0 (0.0)	0.0 (0.0)
Worst Vomiting (Visit 5)	0.0 (0.0)
Worst Numbness (Visit 1)	0.0 (0.0)	0.0 (0.0)
Worst Numbness (Visit 2)	0.5 (0.5)	0.0 (0.0)
Worst Numbness (Visit 3)	0.7 (0.9)	0.0 (0.0)
Worst Numbness (Visit 4)	1.0 (0.0)	0.0 (0.0)
Worst Numbness (Visit 5)	2.0 (0.0)
Worst Effect on General Activities (Visit 1)	0.0 (0.0)	2.0 (1.0)
Worst Effect on General Activities (Visit 2)	1.5 (1.5)	1.0 (0.0)
Worst Effect on General Activities (Visit 3)	1.0 (1.4)	2.0 (0.0)
Worst Effect on General Activities (Visit 4)	0.5 (0.5)	0.0 (0.0)
Worst Effect on General Activities (Visit 5)	1.0 (0.0)
Worst Mood (Visit 1)	1.7 (1.7)	2.0 (2.0)
Worst Mood (Visit 2)	0.5 (0.5)	2.0 (1.0)
Worst Mood (Visit 3)	0.7 (0.5)	0.0 (0.0)
Worst Mood (Visit 4)	0.5 (0.5)	0.0 (0.0)
Worst Mood (Visit 5)	2.0 (0.0)
Worst Effect on Work (Visit 1)	1.7 (1.2)	0.0 (0.0)
Worst Effect on Work (Visit 2)	1.0 (1.0)	0.5 (0.5)
Worst Effect on Work (Visit 3)	0.7 (0.9)	2.0 (0.0)
Worst Effect on Work (Visit 4)	1.0 (0.0)	1.0 (0.0)
Worst Effect on Work (Visit 5)	1.0 (0.0)
Worst Effect on Relationships (Visit 1)	1.0 (1.4)	0.0 (0.0)
Worst Effect on Relationships (Visit 2)	0.0 (0.0)	0.0 (0.0)
Worst Effect on Relationships (Visit 3)	0.7 (0.9)	0.0 (0.0)
Worst Effect on Relationships (Visit 4)	0.5 (0.5)	0.0 (0.0)
Worst Effect on Relationships (Visit 5)	1.0 (0.0)
Worst Walking (Visit 1)	0.7 (0.9)	2.0 (2.0)
Worst Walking (Visit 2)	1.0 (1.0)	0.5 (0.5)
Worst Walking (Visit 3)	0.7 (0.7)	0.0 (0.0)
Worst Walking (Visit 4)	0.5 (0.5)	0.0 (0.0)
Worst Walking (Visit 5)	2.0 (0.0)
Worst Effect on Enjoyment (Visit 1)	0.7 (0.9)	1.5 (0.5)
Worst Effect on Enjoyment (Visit 2)	0.5 (0.5)	1.0 (0.0)
1Worst Effect on Enjoyment (Visit 3)	0.7 (0.9)	2.0 (0.0)
Worst Effect on Enjoyment (Visit 4)	0.5 (0.5)	1.0 (0.0)
Worst Effect on Enjoyment (Visit 5)	1.0 (0.0)

2. Secondary Outcome

Title	Concentration of C-reactive Protein in Serum (mg/L)
Description	The serum concentration of C-reactive protein will be measured by approved methods.
Time Frame	Initial visit and study visits at 3-week intervals up to 4 months

Outcome Measure Data

Analysis Population Description

C-reactive protein was not determined for one subject in the 'Immediate' Arm at Visit 1, one subject in the 'Delayed' Arm at Visit 2 and one subject in the 'Immediate' Arm at Visit 3 due to blood sample not collected. One subject in each arm withdrew consent after visits 2 and 4, respectively.

Arm/Group Title	Immediate and Continuous Dosing	Delayed Dosing
Arm/Group Description	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin
Measure Participants	3	2
Visit 1	0.20 (0.00)	0.15 (0.05)
Visit 2	0.50 (0.12)	0.03 (0.00)
Visit 3	0.30 (0.10)	0.03 (0.00)
Visit 4	0.40 (0.10)	0.03 (0.00)
Visit 5	0.30 (0.00)	0.10 (0.00)

3. Secondary Outcome

Title	Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter)
Description	The serum concentration of circulating tumor cells will be measured by approved methods.
Time Frame	Initial visit and study visits at 3-week intervals up to 4 months

Outcome Measure Data

Analysis Population Description

Circulating tumor cells were not determined for one subject in the 'Immediate' Arm at Visit 1, one subject in the 'Delayed' Arm at Visit 2 and one subject in the 'Immediate' Arm at Visit 3 due to blood sample not collected. One subject in each arm withdrew consent after visits 2 and 4, respectively.

Arm/Group Title	Immediate and Continuous Dosing	Delayed Dosing
Arm/Group Description	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin
Measure Participants	3	2
Visit 1	0.0 (0.0)	0.0 (0.0)
Visit 2	0.0 (0.0)	0.0 (0.0)
Visit 3	0.0 (0.0)	0.0 (0.0)
Visit 4	0.0 (0.0)	0.0 (0.0)
Visit 5	0.0 (0.0)	0.0 (0.0)

4. Secondary Outcome

Title	Sedimentation Rate of Erythrocytes in Blood (mm/hr)
Description	The erythrocyte sedimentation rate will be measured by approved methods.
Time Frame	Initial visit and study visits at 3-week intervals up to 4 months

Outcome Measure Data

Analysis Population Description

Sedimentation rate was not determined for one subject in the 'Immediate' Arm at Visit 1, one subject in the 'Delayed' Arm at Visit 2 and one subject in the 'Immediate' Arm at Visit 3 due to blood sample not collected. One subject in each arm withdrew consent after visits 2 and 4, respectively.

Arm/Group Title	Immediate and Continuous Dosing	Delayed Dosing
Arm/Group Description	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin
Measure Participants	3	2
Visit 1	13.5 (9.5)	17.0 (7.0)
Visit 2	17.3 (8.3)	11.0 (0.0)
Visit 3	20.5 (9.5)	13.0 (0)
Visit 4	14.0 (0.0)	16.0 (0.0)
Visit 5	13.0 (0.0)	18.0 (0.0)

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	Adverse event information was solicited from study subjects at each study visit. CTCAE 4.03 was used to grade adverse events.
Arm/Group Title	Immediate and Continuous Dosing		Delayed Dosing
Arm/Group Description	Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin		Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin
All Cause Mortality
	Immediate and Continuous Dosing		Delayed Dosing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)
Serious Adverse Events
	Immediate and Continuous Dosing		Delayed Dosing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Immediate and Continuous Dosing		Delayed Dosing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.