Cancer BreastPhase 1NCT05410002
Diet Effect on Cancer Treatment Outcome
A Phase 1 study testing Dietary Supplement: N-111 in people with Cancer Breast and Cancer Prostate, run by Optimal Health Research at 3 sites in 2 countries.
Trial summary
The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Cancer Breast, Cancer Prostate
- What is being tested?
- Dietary Supplement: N-111
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Oct 2022to 1 Oct 2024
- Phase
- Phase 1
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers.
- Prostate cancer as determined by a Transrectal Biopsy with associated Prostate- specific antigen blood work.
Who cannot join
- •Patients without the positive diagnosis of breast or prostate cancer.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
India2 sites
KLE Academy of Higher Education & Research
Belagāve, Karnataka, 590010
Indian Institute of Research
Mumbai, 400028
About this study
Official title: A Study on the Effect Diet Has Affecting the Response of Patients Taking N-111 Who Are on a Vegetarian Diet Vs a Non-vegetarian Diet or a Placebo
The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.
Read the detailed description
The study will be evaluated during a double blind, placebo-controlled evaluation of the effect diet has on the response of patients taking N-111 who are on a vegetarian diet vs a non-vegetarian diet or a placebo. This will involve assessing the patients progress or lack thereof over a 3-month period of time as outlined in Outcome Measures section below.
- Conditions
- Cancer Breast, Cancer Prostate
- Being tested
- Dietary Supplement: N-111, Placebo
- Keywords
- Cancer
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: N-111Dietary supplement
Dietary supplement N-111
PlaceboOther
Dietary placebo
| Study group | Role | What they receive |
|---|---|---|
| Vegetarian N-111 group | Active comparator | The group will use a vegetarian diet with the active compactor N-111. Receives: Dietary Supplement: Dietary Supplement: N-111 |
| Non-vegetarian N-111 group. | Active comparator | The group will use a non-vegetarian diet with the active compactor N-111. Receives: Dietary Supplement: Dietary Supplement: N-111 |
| Vegetarian placebo group | Placebo comparator | The group will use a vegetarian diet with a placebo. Receives: Other: Placebo |
| Non-vegetarian placebo control group | Placebo comparator | The group will use a non-vegetarian diet with a placebo. Receives: Other: Placebo |
| Vegetarian control group | No intervention | The group will use a vegetarian diet without the active compactor N-111 or the placebo. |
| Non-vegetarian control group | No intervention | he group will use a non-vegetarian diet without the active compactor N-111 or the placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Comparator: Vegetarian N-111 group
Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
Measured: End of month 3.
Active Comparator: Non-vegetarian N-111 group.
Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
Measured: End of month 3.
Secondary outcomes (2)
Placebo Comparator: Vegetarian placebo group
Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
Measured: End of month 3.
Placebo Comparator: Non-vegetarian placebo control group
Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
Measured: End of month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start12 Oct 2022
- Primary completion1 Apr 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer BreastStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized interventional parallel study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimal Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EA Jeppsen, MD, Study chair, Optimal Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410002
- Sponsor's protocol ID
- N-111012422
- Status last verified
- Oct 2024
- First submitted
- 4 Jun 2022
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effect Diet Has Affecting the Response of Patients Taking N-111 Who Are on a Vegetarian Diet Vs a Non-vegetarian Diet or a Placebo
- ClinicalTrials.gov ID
- NCT05410002
- Acronym / sponsor ID
- N-111012422
- Conditions
- Cancer Breast, Cancer Prostate
- Keywords
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Optimal Health ResearchUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 8 Jun 2022 (actual)
- 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 study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.
Detailed description
The study will be evaluated during a double blind, placebo-controlled evaluation of the effect diet has on the response of patients taking N-111 who are on a vegetarian diet vs a non-vegetarian diet or a placebo. This will involve assessing the patients progress or lack thereof over a 3-month period of time as outlined in Outcome Measures section below.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized interventional parallel study
| Arm | Type | Receives |
|---|---|---|
| Vegetarian N-111 group | Active comparator | Dietary Supplement: Dietary Supplement: N-111The group will use a vegetarian diet with the active compactor N-111. |
| Non-vegetarian N-111 group. | Active comparator | Dietary Supplement: Dietary Supplement: N-111The group will use a non-vegetarian diet with the active compactor N-111. |
| Vegetarian placebo group | Placebo comparator | Other: PlaceboThe group will use a vegetarian diet with a placebo. |
| Non-vegetarian placebo control group | Placebo comparator | Other: PlaceboThe group will use a non-vegetarian diet with a placebo. |
| Vegetarian control group | No intervention | –The group will use a vegetarian diet without the active compactor N-111 or the placebo. |
| Non-vegetarian control group | No intervention | –he group will use a non-vegetarian diet without the active compactor N-111 or the placebo. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers.
- Prostate cancer as determined by a Transrectal Biopsy with associated Prostate- specific antigen blood work.
Key exclusion criteria (1 listed)
- •Patients without the positive diagnosis of breast or prostate cancer.
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 |
|---|---|---|
| Dietary Supplement: N-111Dietary supplement N-111 | Dietary supplement | Non-vegetarian N-111 group., Vegetarian N-111 group |
| PlaceboDietary placebo | Other | Non-vegetarian placebo control group, Vegetarian placebo group |
Primary outcome
Active Comparator: Vegetarian N-111 group
Time frame: End of month 3.
Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
Active Comparator: Non-vegetarian N-111 group.
Time frame: End of month 3.
Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
2 secondary outcomes
Placebo Comparator: Vegetarian placebo group
Time frame: End of month 3.
Placebo Comparator: Non-vegetarian placebo control group
Time frame: End of month 3.
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 Oct 2024.
- 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.
EA Jeppsen, MD study chair
Optimal Health Research
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dietary Supplement: N-111 in people with Cancer Breast and Cancer Prostate, run by Optimal Health Research at 3 sites in 2 countries.
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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, 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.
What does this 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.
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?
Active Comparator: Vegetarian N-111 group (time frame: End of month 3.). 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 3 Oct 2024.