Quality of LifePhase 1/2NCT02486796
Immediate or Delayed Naturopathic Medicine in Combination With Neo-Adjuvant Chemotherapy for Breast Cancer
A Phase 1/2 study testing Reishi mushroom extract, Coenzyme Q10 and Melatonin in people with Quality of Life, run by Midwestern Regional Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quality of Life
- What is being tested?
- Reishi mushroom extract, Coenzyme Q10 and Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 19 Feb 2016to 3 Mar 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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
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.
- Conditions
- Quality of Life
- Being tested
- Reishi mushroom extract, Coenzyme Q10, Melatonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reishi mushroom extractBiological
Also called Ganoderma lucidum
Reishi mushroom preparation produced water-ethanol extraction.
Coenzyme Q10Drug
Also called Ubiquinone, Ubidecarenone
Preparation of coenzyme Q10
MelatoninDrug
Also called N-acetyl-5-methoxy tryptamine
Preparation of melatonin
| Study group | Role | What they receive |
|---|---|---|
| Immediate and Continuous Dosing | Active comparator | Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. Receives: Biological: Reishi mushroom extract; Drug: Coenzyme Q10; Drug: Melatonin |
| Delayed Dosing | Active comparator | Subjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. Receives: Biological: Reishi mushroom extract; Drug: Coenzyme Q10; Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Reported Quality of Life Score
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.
Measured: Initial visit and study visits at 3-week intervals up to 4 months
Secondary outcomes (3)
Concentration of C-reactive Protein in Serum (mg/L)
The serum concentration of C-reactive protein will be measured by approved methods.
Measured: Initial visit and study visits at 3-week intervals up to 4 months
Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter)
The serum concentration of circulating tumor cells will be measured by approved methods.
Measured: Initial visit and study visits at 3-week intervals up to 4 months
Sedimentation Rate of Erythrocytes in Blood (mm/hr)
The erythrocyte sedimentation rate will be measured by approved methods.
Measured: Initial visit and study visits at 3-week intervals up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start19 Feb 2016
- Primary completion3 Mar 2017
- Study completion3 Mar 2017
Why it stopped: Operational barriers prevent critical specimen analyses from being performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Shannon, ND, Principal investigator, Midwestern Regional Medical Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486796
- Sponsor's protocol ID
- MZ2014018
- Status last verified
- Jul 2018
- First submitted
- 24 Jun 2015
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02486796
- Acronym / sponsor ID
- MZ2014018
- Conditions
- Quality of Life
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Operational barriers prevent critical specimen analyses from being performed.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Midwestern Regional Medical CenterUniversity, hospital or other
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Posted 1 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate and Continuous Dosing | Active comparator | Biological: Reishi mushroom extract, Drug: Coenzyme Q10, Drug: MelatoninSubjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 1 Day 1 of their prescribed neoadjuvant chemotherapy. |
| Delayed Dosing | Active comparator | Biological: Reishi mushroom extract, Drug: Coenzyme Q10, Drug: MelatoninSubjects will be dosed with Reishi mushroom extract, Coenzyme Q10 and Melatonin beginning with Cycle 3 Day 1 of their prescribed neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (29 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reishi mushroom extractAlso: Ganoderma lucidumReishi mushroom preparation produced water-ethanol extraction. | Biological | Delayed Dosing, Immediate and Continuous Dosing |
| Coenzyme Q10Also: Ubiquinone, UbidecarenonePreparation of coenzyme Q10 | Drug | Delayed Dosing, Immediate and Continuous Dosing |
| MelatoninAlso: N-acetyl-5-methoxy tryptaminePreparation of melatonin | Drug | Delayed Dosing, Immediate and Continuous Dosing |
Primary outcome
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.
3 secondary outcomes
Concentration of C-reactive Protein in Serum (mg/L)
Time frame: 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
Sedimentation Rate of Erythrocytes in Blood (mm/hr)
Time frame: Initial visit and study visits at 3-week intervals up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Shannon, ND principal investigator
Midwestern Regional Medical Center, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Reishi mushroom extract, Coenzyme Q10 and Melatonin in people with Quality of Life, run by Midwestern Regional Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Reported Quality of Life Score (time frame: Initial visit and study visits at 3-week intervals up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.