Trial Outcomes & Findings for Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer (NCT NCT02486796)

Last Updated: 2018-08-01

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Initial visit and study visits at 3-week intervals up to 4 months

Results posted on

2018-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	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. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin	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. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin
Overall Study STARTED	3	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin	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. Reishi mushroom extract: Reishi mushroom preparation produced water-ethanol extraction. Coenzyme Q10: Preparation of coenzyme Q10 Melatonin: Preparation of melatonin
Overall Study Withdrawal by Subject	1	1
Overall Study Physician Decision	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Initial visit and study visits at 3-week intervals up to 4 months

Population: 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.

Outcome measures

Outcome measures
Measure	Immediate and Continuous Dosing n=3 Participants 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	Delayed Dosing n=2 Participants 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
Subject Reported Quality of Life Score Worst Vomiting (Visit 3)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Vomiting (Visit 4)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Vomiting (Visit 5)	0.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Numbness (Visit 1)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Numbness (Visit 2)	0.5 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Numbness (Visit 3)	0.7 units on a scale Standard Deviation 0.9	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Numbness (Visit 4)	1.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Numbness (Visit 5)	2.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Effect on General Activities (Visit 1)	0.0 units on a scale Standard Deviation 0.0	2.0 units on a scale Standard Deviation 1.0
Subject Reported Quality of Life Score Worst Effect on General Activities (Visit 2)	1.5 units on a scale Standard Deviation 1.5	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Pain (Visit 1)	0.7 units on a scale Standard Deviation 0.9	2.0 units on a scale Standard Deviation 1.0
Subject Reported Quality of Life Score Worst pain (Visit 2)	1.0 units on a scale Standard Deviation 1.0	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Pain (Visit 3)	0.7 units on a scale Standard Deviation 0.9	2.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Pain (Visit 4)	0.5 units on a scale Standard Deviation 0.5	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Pain (Visit 5)	1.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Fatigue (Visit 1)	1.0 units on a scale Standard Deviation 0.8	1.5 units on a scale Standard Deviation 0.5
Subject Reported Quality of Life Score Worst Fatigue (Visit 2)	1.0 units on a scale Standard Deviation 1.0	3.5 units on a scale Standard Deviation 1.5
Subject Reported Quality of Life Score Worst Fatigue (Visit 3)	1.3 units on a scale Standard Deviation 1.2	3.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Fatigue (Visit 4)	1.5 units on a scale Standard Deviation 0.5	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Fatigue (Visit 5)	1.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Nausea (Visit 1)	0.7 units on a scale Standard Deviation 0.9	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Nausea (Visit 2)	0.0 units on a scale Standard Deviation 0.0	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Nausea (Visit 3)	0.3 units on a scale Standard Deviation 0.5	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Nausea (Visit 4)	0.5 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Nausea (Visit 5)	3.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Sleep Disturbance (Visit 1)	3.3 units on a scale Standard Deviation 0.9	3.0 units on a scale Standard Deviation 1.0
Subject Reported Quality of Life Score Worst Sleep Disturbance (Visit 2)	0.5 units on a scale Standard Deviation 0.5	1.0 units on a scale Standard Deviation 1.0
Subject Reported Quality of Life Score Worst Sleep Disturbance (Visit 3)	1.7 units on a scale Standard Deviation 0.5	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Sleep Disturbance (Visit 4)	1.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Sleep Disturbance (Visit 5)	3.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Sleep Distress (Visit 1)	2.3 units on a scale Standard Deviation 1.2	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Sleep Distress (Visit 2)	0.5 units on a scale Standard Deviation 0.5	1.0 units on a scale Standard Deviation 1.0
Subject Reported Quality of Life Score Worst Sleep Distress (Visit 3)	1.0 units on a scale Standard Deviation 0.8	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Sleep Distress (Visit 4)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Sleep Distress (Visit 5)	3.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Shortness of Breath (Visit 1)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Shortness of Breath (Visit 2)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Shortness of Breath (Visit 3)	0.0 units on a scale Standard Deviation 0.0	2.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Shortness of Breath (Visit 4)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Shortness of Breath (Visit 5)	0.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Memory/Recall (Visit 1)	0.7 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 1.5
Subject Reported Quality of Life Score Worst Memory/Recall (Visit 2)	0.5 units on a scale Standard Deviation 0.5	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Memory/Recall (Visit 3)	1.0 units on a scale Standard Deviation 0.8	2.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Memory/Recall (Visit 4)	0.5 units on a scale Standard Deviation 0.5	3.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Memory/Recall (Visit 5)	2.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Appetite (Visit 1)	0.7 units on a scale Standard Deviation 0.5	1.5 units on a scale Standard Deviation 1.5
Subject Reported Quality of Life Score Worst Appetite (Visit 2)	1.0 units on a scale Standard Deviation 1.0	1.5 units on a scale Standard Deviation 1.5
Subject Reported Quality of Life Score Worst Appetite (Visit 3)	2.0 units on a scale Standard Deviation 2.8	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Appetite (Visit 4)	.05 units on a scale Standard Deviation .05	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Appetite (Visit 5)	2.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Drowsiness (Visit 1)	1.0 units on a scale Standard Deviation 0.8	1.5 units on a scale Standard Deviation 0.5
Subject Reported Quality of Life Score Worst Drowsiness (Visit 2)	1.0 units on a scale Standard Deviation 1.0	2.5 units on a scale Standard Deviation 1.5
Subject Reported Quality of Life Score Worst Drowsiness (Visit 3)	1.0 units on a scale Standard Deviation 0.8	3.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Drowsiness (Visit 4)	1.0 units on a scale Standard Deviation 0.0	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Drowsiness (Visit 5)	1.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Dry Mouth (Visit 1)	0.0 units on a scale Standard Deviation 0.0	0.5 units on a scale Standard Deviation 0.5
Subject Reported Quality of Life Score Worst Dry Mouth (Visit 2)	0.5 units on a scale Standard Deviation 0.5	1.5 units on a scale Standard Deviation 1.5
Subject Reported Quality of Life Score Worst Dry Mouth (Visit 3)	0.7 units on a scale Standard Deviation 0.9	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Dry Mouth (Visit 4)	0.5 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Dry Mouth (Visit 15	1.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Sadness (Visit 1)	1.3 units on a scale Standard Deviation 1.2	1.5 units on a scale Standard Deviation 1.5
Subject Reported Quality of Life Score Worst Sadness (Visit 2)	0.0 units on a scale Standard Deviation 0.0	1.5 units on a scale Standard Deviation 1.5
Subject Reported Quality of Life Score Worst Sadness (Visit 3)	0.3 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Sadness (Visit 4)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Sadness (Visit 5)	2.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Vomiting (Visit 1)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Vomiting (Visit 2)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on General Activities (Visit 3)	1.0 units on a scale Standard Deviation 1.4	2.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on General Activities (Visit 4)	0.5 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on General Activities (Visit 5)	1.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Mood (Visit 1)	1.7 units on a scale Standard Deviation 1.7	2.0 units on a scale Standard Deviation 2.0
Subject Reported Quality of Life Score Worst Mood (Visit 2)	0.5 units on a scale Standard Deviation 0.5	2.0 units on a scale Standard Deviation 1.0
Subject Reported Quality of Life Score Worst Mood (Visit 3)	0.7 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Mood (Visit 4)	0.5 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Mood (Visit 5)	2.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Effect on Work (Visit 1)	1.7 units on a scale Standard Deviation 1.2	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on Work (Visit 3)	0.7 units on a scale Standard Deviation 0.9	2.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on Work (Visit 2)	1.0 units on a scale Standard Deviation 1.0	0.5 units on a scale Standard Deviation 0.5
Subject Reported Quality of Life Score Worst Effect on Work (Visit 4)	1.0 units on a scale Standard Deviation 0.0	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on Work (Visit 5)	1.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Effect on Relationships (Visit 1)	1.0 units on a scale Standard Deviation 1.4	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on Relationships (Visit 2)	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on Relationships (Visit 3)	0.7 units on a scale Standard Deviation 0.9	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Walking (Visit 1)	0.7 units on a scale Standard Deviation 0.9	2.0 units on a scale Standard Deviation 2.0
Subject Reported Quality of Life Score Worst Effect on Relationships (Visit 4)	0.5 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on Relationships (Visit 5)	1.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Walking (Visit 2)	1.0 units on a scale Standard Deviation 1.0	0.5 units on a scale Standard Deviation 0.5
Subject Reported Quality of Life Score Worst Walking (Visit 3)	0.7 units on a scale Standard Deviation 0.7	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Walking (Visit 4)	0.5 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Walking (Visit 5)	2.0 units on a scale Standard Deviation 0.0	—
Subject Reported Quality of Life Score Worst Effect on Enjoyment (Visit 1)	0.7 units on a scale Standard Deviation 0.9	1.5 units on a scale Standard Deviation 0.5
Subject Reported Quality of Life Score Worst Effect on Enjoyment (Visit 2)	0.5 units on a scale Standard Deviation 0.5	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score 1Worst Effect on Enjoyment (Visit 3)	0.7 units on a scale Standard Deviation 0.9	2.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on Enjoyment (Visit 4)	0.5 units on a scale Standard Deviation 0.5	1.0 units on a scale Standard Deviation 0.0
Subject Reported Quality of Life Score Worst Effect on Enjoyment (Visit 5)	1.0 units on a scale Standard Deviation 0.0	—

SECONDARY outcome

Timeframe: Initial visit and study visits at 3-week intervals up to 4 months

Population: 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.

The serum concentration of C-reactive protein will be measured by approved methods.

Outcome measures

Outcome measures
Measure	Immediate and Continuous Dosing n=3 Participants 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	Delayed Dosing n=2 Participants 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
Concentration of C-reactive Protein in Serum (mg/L) Visit 1	0.20 mg/dl Standard Deviation 0.00	0.15 mg/dl Standard Deviation 0.05
Concentration of C-reactive Protein in Serum (mg/L) Visit 2	0.50 mg/dl Standard Deviation 0.12	0.03 mg/dl Standard Deviation 0.00
Concentration of C-reactive Protein in Serum (mg/L) Visit 3	0.30 mg/dl Standard Deviation 0.10	0.03 mg/dl Standard Deviation 0.00
Concentration of C-reactive Protein in Serum (mg/L) Visit 4	0.40 mg/dl Standard Deviation 0.10	0.03 mg/dl Standard Deviation 0.00
Concentration of C-reactive Protein in Serum (mg/L) Visit 5	0.30 mg/dl Standard Deviation 0.00	0.10 mg/dl Standard Deviation 0.00

SECONDARY outcome

Timeframe: Initial visit and study visits at 3-week intervals up to 4 months

Population: 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.

The serum concentration of circulating tumor cells will be measured by approved methods.

Outcome measures

Outcome measures
Measure	Immediate and Continuous Dosing n=3 Participants 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	Delayed Dosing n=2 Participants 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
Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter) Visit 2	0.0 cells/ml Standard Deviation 0.0	0.0 cells/ml Standard Deviation 0.0
Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter) Visit 3	0.0 cells/ml Standard Deviation 0.0	0.0 cells/ml Standard Deviation 0.0
Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter) Visit 4	0.0 cells/ml Standard Deviation 0.0	0.0 cells/ml Standard Deviation 0.0
Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter) Visit 5	0.0 cells/ml Standard Deviation 0.0	0.0 cells/ml Standard Deviation 0.0
Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter) Visit 1	0.0 cells/ml Standard Deviation 0.0	0.0 cells/ml Standard Deviation 0.0

SECONDARY outcome

Timeframe: Initial visit and study visits at 3-week intervals up to 4 months

Population: 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.

The erythrocyte sedimentation rate will be measured by approved methods.

Outcome measures

Outcome measures
Measure	Immediate and Continuous Dosing n=3 Participants 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	Delayed Dosing n=2 Participants 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
Sedimentation Rate of Erythrocytes in Blood (mm/hr) Visit 1	13.5 mm/hr Standard Deviation 9.5	17.0 mm/hr Standard Deviation 7.0
Sedimentation Rate of Erythrocytes in Blood (mm/hr) Visit 2	17.3 mm/hr Standard Deviation 8.3	11.0 mm/hr Standard Deviation 0.0
Sedimentation Rate of Erythrocytes in Blood (mm/hr) Visit 3	20.5 mm/hr Standard Deviation 9.5	13.0 mm/hr Standard Deviation 0
Sedimentation Rate of Erythrocytes in Blood (mm/hr) Visit 4	14.0 mm/hr Standard Deviation 0.0	16.0 mm/hr Standard Deviation 0.0
Sedimentation Rate of Erythrocytes in Blood (mm/hr) Visit 5	13.0 mm/hr Standard Deviation 0.0	18.0 mm/hr Standard Deviation 0.0

Adverse Events

Immediate and Continuous Dosing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Dosing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of ClinicalResearch

Midwestern Regional Medical Center, Inc.

Phone: 847-731-1648

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Immediate and Continuous Dosing n=3 Participants 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	Delayed Dosing n=2 Participants 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 n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants