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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

18 Years
Open (Enrolling)

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Trial Information

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

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.

Inclusion Criteria:

- 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.

- 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

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Quality of Life Study

Outcome Description:


Outcome Time Frame:


Safety Issue:


Principal Investigator

Constantine A. Kotsanis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Kotsanis Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2010

Completion Date:

September 2015

Related Keywords:

  • Cancer
  • Quality of Life
  • Qol
  • Questionnaire
  • Survey
  • Insulin Potentiation Targeted Low Dose Chemotherapy
  • Nutritional Therapy
  • Chemotherapy
  • Cancer Treatment
  • Kotsanis Institute
  • The Best Answer for Cancer Foundation
  • Liberty IRB
  • Texas



The Kotsanis InstituteGrapevine, Texas  76051