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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Kotsanis Institute
Sponsor:
Collaborator:
The Best Answer for Cancer Foundation
Information provided by (Responsible Party):
Constantine A. Kotsanis, The Kotsanis Institute
ClinicalTrials.gov Identifier:
NCT01539148
First received: February 16, 2012
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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.


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by The Kotsanis Institute:

Primary Outcome Measures:
  • Quality of Life Study [ Time Frame: yearly ] [ Designated as safety issue: No ]
    MDASI Survey, FACIT


Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539148

Contacts
Contact: Beverly Kotsanis 817-481-6342 DrKotsanis@gmail.com

Locations
United States, Texas
The Kotsanis Institute Recruiting
Grapevine, Texas, United States, 76051
Contact: Beverly Kotsanis    817-481-6342    DrKotsanis@gmail.com   
Sponsors and Collaborators
Constantine A. Kotsanis
The Best Answer for Cancer Foundation
Investigators
Principal Investigator: Constantine A. Kotsanis, MD The Kotsanis Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Constantine A. Kotsanis, Principle Investigator, M.D., The Kotsanis Institute
ClinicalTrials.gov Identifier: NCT01539148     History of Changes
Other Study ID Numbers: 10.03.0010
Study First Received: February 16, 2012
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Kotsanis Institute:
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

ClinicalTrials.gov processed this record on August 26, 2014