CancerIPTLDNCT01539148
A Five-Year Quality of Life Study for Cancer Patients
An observational study of Cancer, run by Constantine A. Kotsanis at 1 site in United States.
Trial summary
The investigator is looking for patients who have been diagnosed with stage 1-4 cancer to enroll in a five year Quality of Life clinical trial study in which the participant has previously elected to use Insulin Potentiation Targeted Low Dose (IPTLD) as a means to treat their illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2015
- 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: The study population will be from patients who have been diagnosed with stage 1-4 cancer that have chosen to use IPTLD and nutritional therapy and have been referred by a physician, word of mouth or through internet website inquiries.
Who may be able to join
- Only patients in active treatment with IPTLD are eligible i.e. patients have consented to treatment with IPTLD.
- Women who are pregnant, or could become pregnant, may not participate in the study.
- Patients 18 years of age or older
- Patients have to be able and willing to complete the various QoL instruments, which will be given upon enrollment and at designated follow-up intervals.
- Patients must have either had the benefits of standard, appropriate therapy and have had that fail, or refuse to receive these therapies after having been informed of the standard of care for their particular stage and diagnosis. This criteria is included for ethical, not clinical reasons.
- In addition, other criteria may be developed that more specifically address: The type, stage, location of the cancer/metastasis. The length of time since diagnosis. Previous treatments attempted and their outcome, Length of time since last treatment and concurrent conventional treatments. Nutritional approaches, other cam treatments, factors that may confound the study results.
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- Ability, commitment of patient to follow IPTLD protocol
- Best Answer for Cancer Foundation and Kotsanis Institute do intend to draw subjects only from within the pool of patients who have elected to undergo IPTLD and nutrition therapy as their treatment of choice; limiting the universe of subjects to IPTLD patients removes the confounding effects of patient treatment choice and possible consideration of other treatment arms from the design.
- The focus is simple: it is to follow IPTLD patients and determine longitudinal impacts of treatment on quality of life experienced by IPTLD patients as a treatment group.
- It is to allow comparison with well-documented QoL results from conventional chemotherapy. This is the original intent, and recruitment efforts for participants will remain within those who are IPTLD patients.
- The initial, baseline QoL testing of IPTLD patients who choose to be in the study will include some questions designed to elicit the reasons the patient decided on IPTLD and nutrition therapy. Documenting these choices can serve two purposes; correlations between reasons, and the attitudes they reveal about factors known to impact QoL, such a positive sense of controlling one's health choices, can be drawn. Further, once these factors are accounted for, some inferences about the extent to which IPTLD and nutrition therapy are responsible for impacts on QoL can be derived.
Who cannot join
- The Medical Director/Principal Investigator will consider excluding specific cancers, for ethical reasons, that are intractable and known to have a rapid course, or which are known to be unresponsive to IPTLD.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Kotsanis Institute
Grapevine, Texas, 76051
Beverly Kotsanis, 817-481-6342, DrKotsanis@gmail.com
About this study
Official title: A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLDSM ) Chemotherapy and Nutrition Therapy in the Treatment of Cancer - The IPTLDSM QoL Broad Study
The investigator is looking for patients who have been diagnosed with stage 1-4 cancer to enroll in a five year Quality of Life clinical trial study in which the participant has previously elected to use Insulin Potentiation Targeted Low Dose (IPTLD) as a means to treat their illness. This study is a quality of life study and not a treatment study. Participants participating in the study will be asked to complete quality of life questionnaires. The questionnaires completed by the patients will measure mood, energy level, ability to function, level of pain, and other measures that indicate how a patient feels about the quality of their daily living.
Read the detailed description
Patients will complete surveys once per month during their participation in the quality of life study, and then a series of follow-up surveys: every two months the second year; every three (3) months the third year and every six months the fourth and fifth year.
- Conditions
- Cancer
- Keywords
- Quality of Life, Qol, Questionnaire, Survey, Insulin Potentiation Targeted Low Dose Chemotherapy, IPTLD, Nutritional Therapy, Chemotherapy, Cancer Treatment, Kotsanis Institute, The Best Answer for Cancer Foundation, Liberty IRB, Texas
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Study
MDASI Survey, FACIT
Measured: yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startMar 2010
- Primary completionMar 2015 (estimated)
- Study completionSep 2015 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Constantine A. Kotsanis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Best Answer for Cancer Foundation
- Responsible party
- Sponsor-investigator, Constantine A. Kotsanis, The Kotsanis Institute
- Investigators
- Constantine A. Kotsanis, MD, Principal investigator, The Kotsanis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539148
- Sponsor's protocol ID
- 10.03.0010
- Acronym
- IPTLD
- Status last verified
- May 2013
- First submitted
- 16 Feb 2012
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLDSM ) Chemotherapy and Nutrition Therapy in the Treatment of Cancer - The IPTLDSM QoL Broad Study
- ClinicalTrials.gov ID
- NCT01539148
- Acronym / sponsor ID
- IPTLD / 10.03.0010
- Conditions
- Cancer
- Keywords
- Quality of Life, Qol, Questionnaire, Survey, Insulin Potentiation Targeted Low Dose Chemotherapy, IPTLD, Nutritional Therapy, Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Constantine A. KotsanisIndustry (pharma, biotech, devices)
- Collaborators
- Best Answer for Cancer Foundation
- Study start
- Mar 2010
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 27 Feb 2012 (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 investigator is looking for patients who have been diagnosed with stage 1-4 cancer to enroll in a five year Quality of Life clinical trial study in which the participant has previously elected to use Insulin Potentiation Targeted Low Dose (IPTLD) as a means to treat their illness. This study is a quality of life study and not a treatment study. Participants participating in the study will be asked to complete quality of life questionnaires. The questionnaires completed by the patients will measure mood, energy level, ability to function, level of pain, and other measures that indicate how a patient feels about the quality of their daily living.
Detailed description
Patients will complete surveys once per month during their participation in the quality of life study, and then a series of follow-up surveys: every two months the second year; every three (3) months the third year and every six months the fourth and fifth year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be from patients who have been diagnosed with stage 1-4 cancer that have chosen to use IPTLD and nutritional therapy and have been referred by a physician, word of mouth or through internet website inquiries.
Key inclusion criteria (11 listed)
- Only patients in active treatment with IPTLD are eligible i.e. patients have consented to treatment with IPTLD.
- Women who are pregnant, or could become pregnant, may not participate in the study.
- Patients 18 years of age or older
- Patients have to be able and willing to complete the various QoL instruments, which will be given upon enrollment and at designated follow-up intervals.
- Patients must have either had the benefits of standard, appropriate therapy and have had that fail, or refuse to receive these therapies after having been informed of the standard of care for their particular stage and diagnosis. This criteria is included for ethical, not clinical reasons.
Key exclusion criteria (1 listed)
- The Medical Director/Principal Investigator will consider excluding specific cancers, for ethical reasons, that are intractable and known to have a rapid course, or which are known to be unresponsive to IPTLD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life Study
Time frame: yearly
MDASI Survey, FACIT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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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.
Constantine A. Kotsanis, MD principal investigator
The Kotsanis Institute
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 Constantine A. Kotsanis 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 11 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: status not confirmed, as of the sponsor's last update on 3 May 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beverly Kotsanis (817-481-6342, DrKotsanis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Study (time frame: yearly). 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 May 2013.