CancerIPTLDAZCAMNCT02598479
A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer
An observational study of Cancer, run by Best Answer for Cancer Foundation at 1 site in United States.
Trial summary
The IPTLD QoL Broad Study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- IPTLD and nutrition therapy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2018
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 who have chosen to receive IPTLD with nutrition therapy
Who may be able to join
- diagnosis of cancer,
- age older than 18 years,
- requesting IPTLD and nutrition therapy
Who cannot join
- diagnosis other than cancer,
- age younger than 18 years,
- requesting conventional chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Center for Advanced Medicine
Scottsdale, Arizona, 85258
About this study
Official title: The IPTLD QoL Broad Study A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer
The IPTLD QoL Broad Study.
Read the detailed description
A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer.
- Conditions
- Cancer
- Being tested
- IPTLD and nutrition therapy
- Keywords
- Cancer, Insulin Potentiation Low Dose Chemotherapy, IPT, IPTLD, Nutrition therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPTLD and nutrition therapyOther
The measurement of Quality of Life in patients who choose to use Insulin Potentiation Low Dose Therapy and Nutritional Therapy in the treatment of cancer
| Study group | Role | What they receive |
|---|---|---|
| IPTLD and nutrition therapy | Patients presenting to the Arizona Center for Advanced Medicine for the treatment of cancer using Insulin Potentiation Low Dose Chemotherapy and Nutrition Therapy Receives: Other: IPTLD and nutrition therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Quality of Life measured by questionnaires
Improvement in Quality of Life using Insulin Potentiation Low Dose Chemotherapy and Nutrition Therapy for the Treatment of Cancer, as measured by MD Anderson's MDASI questionnaires
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2018
- Study completionAug 2018
Why it stopped: The IRB which was overseeing the study stopped overseeing it
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Best Answer for Cancer Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha M Grout, MD, MD(H), Principal investigator, Arizona Center for Advanced Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598479
- Sponsor's protocol ID
- Protocol V1- 08-12-2015
- Acronym
- IPTLDAZCAM
- Status last verified
- Aug 2018
- First submitted
- 4 Nov 2015
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IPTLD QoL Broad Study A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer
- ClinicalTrials.gov ID
- NCT02598479
- Acronym / sponsor ID
- IPTLDAZCAM / Protocol V1- 08-12-2015
- Conditions
- Cancer
- Keywords
- Cancer, Insulin Potentiation Low Dose Chemotherapy, IPT, IPTLD, Nutrition therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The IRB which was overseeing the study stopped overseeing it
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Best Answer for Cancer FoundationUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 6 Nov 2015 (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 IPTLD QoL Broad Study.
Detailed description
A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPTLD and nutrition therapy | – | Other: IPTLD and nutrition therapyPatients presenting to the Arizona Center for Advanced Medicine for the treatment of cancer using Insulin Potentiation Low Dose Chemotherapy and Nutrition Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who have chosen to receive IPTLD with nutrition therapy
Key inclusion criteria (3 listed)
- diagnosis of cancer,
- age older than 18 years,
- requesting IPTLD and nutrition therapy
Key exclusion criteria (3 listed)
- diagnosis other than cancer,
- age younger than 18 years,
- requesting conventional chemotherapy
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 |
|---|---|---|
| IPTLD and nutrition therapyThe measurement of Quality of Life in patients who choose to use Insulin Potentiation Low Dose Therapy and Nutritional Therapy in the treatment of cancer | Other | IPTLD and nutrition therapy |
Primary outcome
Improvement in Quality of Life measured by questionnaires
Time frame: 5 years
Improvement in Quality of Life using Insulin Potentiation Low Dose Chemotherapy and Nutrition Therapy for the Treatment of Cancer, as measured by MD Anderson's MDASI questionnaires
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
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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.
Martha M Grout, MD, MD(H) principal investigator
Arizona Center for Advanced Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Best Answer for Cancer Foundation at 1 site 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Improvement in Quality of Life measured by questionnaires (time frame: 5 years). 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 28 Aug 2018.