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Breast Neoplasms

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Ubiquinone

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Reishi

Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy.

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 preparation produced water-ethanol extraction.

Reishi mushroom extract

Christina Shannon, ND

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.

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

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

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.

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

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

The erythrocyte sedimentation rate will be measured by approved methods.

Midwestern Regional Medical Center

Adverse event information was solicited from study subjects at each study visit. CTCAE 4.03 was used to grade adverse events.

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

Immediate and Continuous 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

Delayed Dosing

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Director of ClinicalResearch

Worst Pain (Visit 1)

Worst pain (Visit 2)

Worst Pain (Visit 3)

Worst Pain (Visit 4)

Worst Pain (Visit 5)

Worst Fatigue (Visit 1)

Worst Fatigue (Visit 2)

Worst Fatigue (Visit 3)

Worst Fatigue (Visit 4)

Worst Fatigue (Visit 5)

Worst Nausea (Visit 1)

Worst Nausea (Visit 2)

Worst Nausea (Visit 3)

Worst Nausea (Visit 4)

Worst Nausea (Visit 5)

Worst Sleep Disturbance (Visit 1)

Worst Sleep Disturbance (Visit 2)

Worst Sleep Disturbance (Visit 3)

Worst Sleep Disturbance (Visit 4)

Worst Sleep Disturbance (Visit 5)

Worst Sleep Distress (Visit 1)

Worst Sleep Distress (Visit 2)

Worst Sleep Distress (Visit 3)

Worst Sleep Distress (Visit 4)

Worst Sleep Distress (Visit 5)

Worst Shortness of Breath (Visit 1)

Worst Shortness of Breath (Visit 2)

Worst Shortness of Breath (Visit 3)

Worst Shortness of Breath (Visit 4)

Worst Shortness of Breath (Visit 5)

Worst Memory/Recall (Visit 1)

Worst Memory/Recall (Visit 2)

Worst Memory/Recall (Visit 3)

Worst Memory/Recall (Visit 4)

Worst Memory/Recall (Visit 5)

Worst Appetite (Visit 1)

Worst Appetite (Visit 2)

Worst Appetite (Visit 3)

Worst Appetite (Visit 4)

Worst Appetite (Visit 5)

Worst Drowsiness (Visit 1)

Worst Drowsiness (Visit 2)

Worst Drowsiness (Visit 3)

Worst Drowsiness (Visit 4)

Worst Drowsiness (Visit 5)

Worst Dry Mouth (Visit 1)

Worst Dry Mouth (Visit 2)

Worst Dry Mouth (Visit 3)

Worst Dry Mouth (Visit 4)

Worst Dry Mouth (Visit 15

Worst Sadness (Visit 1)

Worst Sadness (Visit 2)

Worst Sadness (Visit 3)

Worst Sadness (Visit 4)

Worst Sadness (Visit 5)

Worst Vomiting (Visit 1)

Worst Vomiting (Visit 2)

Worst Vomiting (Visit 3)

Worst Vomiting (Visit 4)

Worst Vomiting (Visit 5)

Worst Numbness (Visit 1)

Worst Numbness (Visit 2)

Worst Numbness (Visit 3)

Worst Numbness (Visit 4)

Worst Numbness (Visit 5)

Worst Effect on General Activities (Visit 1)

Worst Effect on General Activities (Visit 2)

Worst Effect on General Activities (Visit 3)

Worst Effect on General Activities (Visit 4)

Worst Effect on General Activities (Visit 5)

Worst Mood (Visit 1)

Worst Mood (Visit 2)

Worst Mood (Visit 3)

Worst Mood (Visit 4)

Worst Mood (Visit 5)

Worst Effect on Work (Visit 1)

Worst Effect on Work (Visit 2)

Worst Effect on Work (Visit 3)

Worst Effect on Work (Visit 4)

Worst Effect on Work (Visit 5)

Worst Effect on Relationships (Visit 1)

Worst Effect on Relationships (Visit 2)

Worst Effect on Relationships (Visit 3)

Worst Effect on Relationships (Visit 4)

Worst Effect on Relationships (Visit 5)

Worst Walking (Visit 1)

Worst Walking (Visit 2)

Worst Walking (Visit 3)

Worst Walking (Visit 4)

Worst Walking (Visit 5)

Worst Effect on Enjoyment (Visit 1)

Worst Effect on Enjoyment (Visit 2)

1Worst Effect on Enjoyment (Visit 3)

Worst Effect on Enjoyment (Visit 4)

Worst Effect on Enjoyment (Visit 5)

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.

Subject Reported Quality of Life Score

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

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.

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

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.

Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter)

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.

Sedimentation Rate of Erythrocytes in Blood (mm/hr)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer	NCT02486796	Quality of Life	Reishi mushroom... Coenzyme Q10 Melatonin	18 Years -	Midwestern Regional Medical Center
Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer	NCT02486796	Quality of Life	Reishi mushroom... Coenzyme Q10 Melatonin	18 Years -	Midwestern Regional Medical Center

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