A Five-Year Quality of Life Study for Cancer Patients (IPTLD)

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.

Study Overview

• Status: Unknown
• Conditions: Cancer

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Texas
    • Grapevine, Texas, United States, 76051
      • Recruiting
      • The Kotsanis Institute
      • Contact: Beverly Kotsanis; Phone Number: 817-481-6342; Email: DrKotsanis@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 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.

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Study	MDASI Survey, FACIT	yearly

Collaborators and Investigators

• Sponsor: Constantine A. Kotsanis
• Collaborators: Best Answer for Cancer Foundation
• Investigators: Principal Investigator: Constantine A. Kotsanis, MD, The Kotsanis Institute

Publications and helpful links

Helpful Links

• The Kotsanis Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimate): February 27, 2012

Study Record Updates

• Last Update Posted (Estimate): May 3, 2013
• Last Update Submitted That Met QC Criteria: May 1, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Quality of Life; Questionnaire; Survey; Chemotherapy; IPTLD; Cancer Treatment; Nutritional Therapy; Qol; Texas; Insulin Potentiation Targeted Low Dose Chemotherapy; Kotsanis Institute; The Best Answer for Cancer Foundation; Liberty IRB
• Other Study ID Numbers: 10.03.0010