Breast CancerPhase 2/3NCT02286778

Eradication of Malignant Carcinoma in the Breast Tissue

A Phase 2/3 study testing Acetogenins in people with Breast Cancer, run by Optimal Health Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to confirm the findings of an early study and expand our knowledge of treating Malignant Carcinoma in the Breast Tissue Using an ATP (Adenosine-5'-Triphosphate) Inhibitor. Read more about this study

Who is it for?: Ages 35 to 75 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: Acetogenins
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: No sites listed yet
Study dates: Feb 2016to 1 Aug 2017
Phase: Phase 2/3
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 35 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of breast cancer
Referred to the study by their treating physician

Who cannot join

Any type of treatment for breast cancer before starting the study

About this study

Official title: The Eradication of Malignant Carcinoma in the Breast Tissue Using an ATP (Adenosine-5'-Triphosphate) Inhibitor

Conditions: Breast Cancer
Being tested: Acetogenins, Placebo
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcetogeninsDietary supplement
Acetogenins BID for 12 months
PlaceboDietary supplement

Study groups in NCT02286778
Study group	Role	What they receive
Acetogenins	Active comparator	Dietary Supplement: Acetogenins BID for 12 months Receives: Dietary Supplement: Acetogenins
Placebo	Placebo comparator	Dietary Supplement: No Acetogenins BID for 12 months Receives: Dietary Supplement: Placebo
Control	No intervention	Control subjects will not receive the Acetogenins or the placebo. They will be evaluated every other month to monitor disease progress.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants tumor free
assessed by MRI
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 20161 Aug 2017

First posted10 Nov 2014 (estimated)
Study startFeb 2016
Primary completionJan 2017
Study completion1 Aug 2017

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02286778
Sponsor's protocol ID: F-9892131B
Status last verified: Aug 2017
First submitted: 3 Nov 2014
Last updated: 3 Aug 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Eradication of Malignant Carcinoma in the Breast Tissue Using an ATP (Adenosine-5'-Triphosphate) Inhibitor
ClinicalTrials.gov ID: NCT02286778
Acronym / sponsor ID: F-9892131B
Conditions: Breast Cancer
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Optimal Health ResearchUniversity, hospital or other
Study start: Feb 2016
Primary completion: Jan 2017 (actual)
Study completion: 1 Aug 2017 (actual)
First posted: 10 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Acetogenins	Active comparator	Dietary Supplement: AcetogeninsDietary Supplement: Acetogenins BID for 12 months
Placebo	Placebo comparator	Dietary Supplement: PlaceboDietary Supplement: No Acetogenins BID for 12 months
Control	No intervention	–Control subjects will not receive the Acetogenins or the placebo. They will be evaluated every other month to monitor disease progress.

Who may qualify

Ages: 35 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Clinical diagnosis of breast cancer
Referred to the study by their treating physician

Key exclusion criteria (1 listed)

Any type of treatment for breast cancer before starting 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
AcetogeninsAcetogenins BID for 12 months	Dietary supplement	Acetogenins
Placebo	Dietary supplement	Placebo

Primary outcome

Number of participants tumor free
Time frame: 12 months
assessed by MRI

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

John A Shaw, MD principal investigator

Optimal Health Research

Steven Osguthorpe, ND principal investigator

Optimal Health Research

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Acetogenins in people with Breast Cancer, run by Optimal Health Research.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 3 Aug 2017. 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. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of participants tumor free (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02286778.

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 3 Aug 2017.