Breast CancerNCT02217033
Effects of 'R' (Electro-kinetic Beverage) on Insomnia, Fatigue, and Depression in Breast Cancer Patients Having Adjuvant Chemo
A study testing 'R' (Electro-kinetically altered beverage) in people with Breast Cancer, run by South Sound Care Foundation at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects of consuming "R" on quality of life in the areas of insomnia, fatigue, and depression in female breast cancer patients receiving multi-cycle adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 'R' (Electro-kinetically altered beverage)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, non-smokers ≥ 18 years of age
- Histologically or cytologically confirmed diagnosis of Stage I or II adenocarcinoma of the breast and a candidate for adjuvant chemotherapy
- Scheduled to receive 4 cycles of adjuvant Taxotere and Cytoxan chemotherapy (TC): docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on Day 1 of each 21-day cycle
- Eastern Cooperative Oncology Group Status (ECOG) performance status of ≤ 1
- No prior treatment for breast cancer other than surgery
- Adequate baseline organ function as evidenced by:
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- Hemoglobin ≥ 9 g/dL
- Absolute neutrophil count ≥ 1.5 x 109 cells/mm3
- Platelet count ≥ 100,000 cells/mm3
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
- Alkaline phosphatase ≤ 1.5 x ULN
- No history of other malignancies within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma or squamous cell carcinoma of the skin that have been previously treated with curative intent
- Women of childbearing potential who commit to using two forms of highly effective non-hormonal contraception either by the subject and/or partner during the study
- Negative urine pregnancy test at screening
- Negative urine drug screen (UDS) for drugs of abuse including cotinine (nicotine) at screening
- Subjects must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent
Who cannot join
- Preexisting diagnosed psychiatric disorder as defined by The Diagnostic and Statistical Manual (DSM) of Mental Disorders (published by the American Psychiatric Association). Subjects with a diagnosis of depression will be allowed to enter into study as long as they have been treated with medication for ≥ 6 months and/or depression is considered to be well controlled
- Pregnant or lactating
- Diabetes
- Concomitant use of any sleeping agents during the course of the study (Anti- anxiety medications will be allowed)
- Steroid therapy other than the standard prescribed therapy of either of the following during the course of the study:
- Dexamethasone 4-12 mg IV on Day 1 of any cycle
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- Dexamethasone 4-12 mg PO on Day 2 and Day 3 of any cycle
- Anti-estrogen therapy other than the standard prescribed therapy of one of the following:
- Tamoxifen/Nolvadex 20 mg PO daily
- Anastrazole/Arimidex 1 mg PO daily
- Letrozole/Femara 2.5 mg PO daily
- Exemestane/Aromasin 25 mg PO daily
- Use of any other antiemetic regimen other than the following (with the exception of PO antiemetics):
- Emend /Aprepitant150 mg IV on Day 1 of any cycle
- Aloxi/Palonosetron 0.25 mg IV on Day 1 of any cycle
- Dexamethasone 8 mg IV on Day 1 of any cycle
- Dexamethasone 8 mg PO on Day 2 and Day 3 of any cycle
- Zofran/Ondansetron 12 mg IV on Day 1 of any cycle
- Kytrile/Granisetron 1-2 mg IV on Day 1 of any cycle
- Therapy with any immunomodulatory or immunosuppressive drugs within 6 months prior to enrollment
- Known history of positive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and Hepatitis C antibody
- Any change in the initially prescribed chemotherapy
- Use of herbal remedies, dietary supplements or mega-vitamins, with the exception of a multi-vitamin
- Investigator deems the subject to be unable or unwilling to comply with the requirements of the protocol
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
NWMS Bonney Lake - Medical Oncology
Bonney Lake, Washington, 98391
NWMS Federal Way - Medical Oncology
Federal Way, Washington, 98003
NWMS Gig Harbor - Medical Oncology
Gig Harbor, Washington, 98332
NWMS Lakewood - Medical Oncology
Lakewood, Washington, 98499
Rainier Hematology-Oncology, WA
Puyallup, Washington, 98373
NWMS Tacoma - Medical Oncology & Infectious Diseases
Tacoma, Washington, 98405
About this study
Official title: A Pilot Study Evaluating the Effect of 'R' (Electro-Kinetically Altered Beverage) on Insomnia, Fatigue and Depression in Breast Cancer Patients Receiving Adjuvant Chemotherapy
The purpose of this study is to evaluate the effects of consuming "R" on quality of life in the areas of insomnia, fatigue, and depression in female breast cancer patients receiving multi-cycle adjuvant chemotherapy.
Read the detailed description
Female breast cancer patients eligible for adjuvant therapy with four cycles of Taxotere and Cytoxan chemotherapy after surgery will be enrolled for the study.
Eligible subjects will begin to consume either "R" or purified water (placebo) just prior to the 1st cycle of chemotherapy. Subjects will continue to consume either "R" or placebo through Cycle 1, Cycle 2, Cycle 3, Cycle 4, and for an additional 12 weeks after completing chemotherapy.
Study procedures will include clinical lab assessments, analysis of inflammatory markers, RNA biomarkers, adverse events, subject diary, and quality of life measurements for insomnia, fatigue and depression.
- Conditions
- Breast Cancer
- Being tested
- 'R' (Electro-kinetically altered beverage), Placebo (water)
- Keywords
- Breast Cancer, Stage I breast cancer, Stage II breast cancer, Water study, 'R', Electro-kinetically altered beverage, altered beverage, Insomnia, Fatigue, Depression, Adjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms, Sleep Initiation and Maintenance Disorders, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'R' (Electro-kinetically altered beverage)Other
Placebo (water)Other
| Study group | Role | What they receive |
|---|---|---|
| Purified Water | Placebo comparator | In this arm, eligible subjects will begin to consume purified water (placebo) just prior to the 1st cycle of chemotherapy. Subjects will continue to consume the placebo through their chemotherapy and then for an additional 12 weeks after completing chemotherapy.
Subjects will consume a specific volume based on the following weight categories: <150 lb = 2 bottles/day; ≥150 lb and <225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume placebo for a minimum of 168 days. Receives: Other: Placebo (water) |
| 'R' (Electro-kinetically altered beverage) | Experimental | Patients randomized to this arm will begin to consume "R" (Electro-kinetically altered beverage) just prior to the 1st cycle of chemotherapy and continue it through their chemotherapy cycles and then for an additional 12 weeks after completing chemotherapy.
Subjects will consume a specific volume based on the following weight categories: <150 lb = 2 bottles/day; ≥150 lb and <225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume R for a minimum of 168 days. Receives: Other: 'R' (Electro-kinetically altered beverage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of consuming "R" on quality of life in the areas of insomnia in breast cancer patients receiving multi-cycle adjuvant chemotherapy
SleepMed Insomnia Questionnaire: This is a test to assess, in general, how a subject is feeling about their sleep using a "0-4" point scale - with the "0" representing no problem with sleep and "4" representing a big problem with how a subject feels about the quality of their sleep.
Measured: Patients will be followed for up to 25 weeks
The effects of consuming "R" on quality of life in the areas of fatigue in breast cancer patients receiving multi-cycle adjuvant chemotherapy
FACIT Fatigue Scale: A list of questions that asks a patient how fatigued they have felt in the last 7 days.
Measured: Patients will be followed for up to 25 weeks
Secondary outcomes (1)
The effects of consuming "R" on quality of life in the areas of depression in breast cancer patients receiving multi-cycle adjuvant chemotherapy
Beck Depression Inventory-II: A list of statements that ask a subject about the way they have been feeling for the last two weeks.
Measured: Patients will be followed for up to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJan 2013
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: After an interim analysis the Company providing the product decided not to continue with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Sound Care Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francis (Frank) Senecal, MD, South Sound Care Foundation
- Investigators
- Francis (Frank) Senecal, MD, Principal investigator, Northwest Medical Specialties
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217033
- Sponsor's protocol ID
- R822662
- Status last verified
- Apr 2017
- First submitted
- 8 Aug 2014
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Effect of 'R' (Electro-Kinetically Altered Beverage) on Insomnia, Fatigue and Depression in Breast Cancer Patients Receiving Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02217033
- Acronym / sponsor ID
- R822662
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Stage I breast cancer, Stage II breast cancer, Water study, 'R', Electro-kinetically altered beverage, altered beverage, Insomnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After an interim analysis the Company providing the product decided not to continue with the study
- Enrolment
- 16 participants (actual)
- Lead sponsor
- South Sound Care FoundationUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of consuming "R" on quality of life in the areas of insomnia, fatigue, and depression in female breast cancer patients receiving multi-cycle adjuvant chemotherapy.
Detailed description
Female breast cancer patients eligible for adjuvant therapy with four cycles of Taxotere and Cytoxan chemotherapy after surgery will be enrolled for the study.
Eligible subjects will begin to consume either "R" or purified water (placebo) just prior to the 1st cycle of chemotherapy. Subjects will continue to consume either "R" or placebo through Cycle 1, Cycle 2, Cycle 3, Cycle 4, and for an additional 12 weeks after completing chemotherapy.
Study procedures will include clinical lab assessments, analysis of inflammatory markers, RNA biomarkers, adverse events, subject diary, and quality of life measurements for insomnia, fatigue and depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purified Water | Placebo comparator | Other: Placebo (water)In this arm, eligible subjects will begin to consume purified water (placebo) just prior to the 1st cycle of chemotherapy. Subjects will continue to consume the placebo through their chemotherapy and then for an additional 12 weeks after completing chemotherapy. Subjects will consume a specific volume based on the following weight categories: <150 lb = 2 bottles/day; ≥150 lb and <225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume placebo for a minimum of 168 days. |
| 'R' (Electro-kinetically altered beverage) | Experimental | Other: 'R' (Electro-kinetically altered beverage)Patients randomized to this arm will begin to consume "R" (Electro-kinetically altered beverage) just prior to the 1st cycle of chemotherapy and continue it through their chemotherapy cycles and then for an additional 12 weeks after completing chemotherapy. Subjects will consume a specific volume based on the following weight categories: <150 lb = 2 bottles/day; ≥150 lb and <225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume R for a minimum of 168 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female, non-smokers ≥ 18 years of age
- Histologically or cytologically confirmed diagnosis of Stage I or II adenocarcinoma of the breast and a candidate for adjuvant chemotherapy
- Scheduled to receive 4 cycles of adjuvant Taxotere and Cytoxan chemotherapy (TC): docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on Day 1 of each 21-day cycle
- Eastern Cooperative Oncology Group Status (ECOG) performance status of ≤ 1
- No prior treatment for breast cancer other than surgery
Key exclusion criteria (24 listed)
- Preexisting diagnosed psychiatric disorder as defined by The Diagnostic and Statistical Manual (DSM) of Mental Disorders (published by the American Psychiatric Association). Subjects with a diagnosis of depression will be allowed to enter into study as long as they have been treated with medication for ≥ 6 months and/or depression is considered to be well controlled
- Pregnant or lactating
- Diabetes
- Concomitant use of any sleeping agents during the course of the study (Anti- anxiety medications will be allowed)
- Steroid therapy other than the standard prescribed therapy of either of the following during the course of 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 |
|---|---|---|
| 'R' (Electro-kinetically altered beverage) | Other | 'R' (Electro-kinetically altered beverage) |
| Placebo (water) | Other | Purified Water |
Primary outcome
The effects of consuming "R" on quality of life in the areas of insomnia in breast cancer patients receiving multi-cycle adjuvant chemotherapy
Time frame: Patients will be followed for up to 25 weeks
SleepMed Insomnia Questionnaire: This is a test to assess, in general, how a subject is feeling about their sleep using a "0-4" point scale - with the "0" representing no problem with sleep and "4" representing a big problem with how a subject feels about the quality of their sleep.
The effects of consuming "R" on quality of life in the areas of fatigue in breast cancer patients receiving multi-cycle adjuvant chemotherapy
Time frame: Patients will be followed for up to 25 weeks
FACIT Fatigue Scale: A list of questions that asks a patient how fatigued they have felt in the last 7 days.
1 secondary outcome
The effects of consuming "R" on quality of life in the areas of depression in breast cancer patients receiving multi-cycle adjuvant chemotherapy
Time frame: Patients will be followed for up to 25 weeks
Results and safety
The study was stopped early (reason given: After an interim analysis the Company providing the product decided not to continue with the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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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.
Francis (Frank) Senecal, MD principal investigator
Northwest Medical Specialties
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'R' (Electro-kinetically altered beverage) in people with Breast Cancer, run by South Sound Care Foundation at 6 sites in United States.
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 16 inclusion and 24 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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: After an interim analysis the Company providing the product decided not to continue with the study). Results are not available in the source record.
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?
The effects of consuming "R" on quality of life in the areas of insomnia in breast cancer patients receiving multi-cycle adjuvant chemotherapy (time frame: Patients will be followed for up to 25 weeks). The study lists 2 primary outcomes in all. 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 18 Apr 2017.