Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care

This study has been completed.
Sponsor:
Information provided by:
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT00523107
First received: August 21, 2007
Last updated: June 12, 2009
Last verified: June 2009
  Purpose

The objective of this study is to conduct a trial in the spirit of providing as much as possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and safety of PG2 for relieving fatigue among advanced cancer patients who are under standard palliative care (SPC) at hospice setting and have no further curative options available. Patient's fatigue status, to be measured by the Brief Fatigue Inventory-Taiwanese Form (BFI-T), will be the primary endpoint. The fatigue improvement response rate among patients between two study arms will then be compared as the basis for efficacy evaluation at the end of the first treatment cycle, and will be the primary endpoint. Other endpoints, the fatigue improvement response rate and the mean fatigue scores change from baseline among patients within and between cycles will be included in the secondary efficacy endpoints, and will be compared between two study arms. Patients' quality of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life (QoL) will be also measured by 11 questions (SS11) from EORTC QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints include Karnofsky performance scores, and weight change and its related c-reactive protein level of the patients.

* BFI-T (Brief Fatigue Inventory - Taiwan) : The BFI is a 9-item self-administered questionnaire which was developed by MD Anderson Cancer Center offers assessing levels of fatigue. Subjects rate each item based on how they felt for the preceding week using a 1-10 numeric rating scale (10 being the most unfavorable response). The single construct of the BFI allows for the mean of the nine items to be the overall score. The score is categorized as mild (1-3), moderate (4-6), and severe (7-10). The scale is a reliable instrument that correlates highly with similar fatigue and performance status measures.


Condition Intervention Phase
Fatigue
Drug: PG2
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care

Resource links provided by NLM:


Further study details as provided by PhytoHealth Corporation:

Primary Outcome Measures:
  • The fatigue improvement response rate among patients between two study arms will be compared as the basis for efficacy evaluation at the end of the first treatment cycle. [ Time Frame: within and between each cycle (4 weeks) ]

Secondary Outcome Measures:
  • The fatigue improvement response rate among patients within and between cycles (by BFI-T) [ Time Frame: within and between cycles (4 weeks) ]
  • The fatigue improvement by multiple BFI-T score levels among patients between two study arms [ Time Frame: within and between cycles (4 weeks) ]
  • The mean fatigue scores change from baseline among patients within and between cycles (by BFI-T) [ Time Frame: within and between cycles (4 weeks) ]
  • Symptoms/Quality of Life Assessments: SS11 of EORTC QLQ-C30 includes eleven questions to assess the symptoms/QoL parameters: sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life [ Time Frame: within and between cycles (4 weeks) ]
  • Karnofsky performance score [ Time Frame: within and between cycles (4 weeks) ]
  • Weight change and the related blood c-reactive protein level [ Time Frame: within and between cycles (4 weeks) ]

Enrollment: 91
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: PG2
    Study drugs of PG2 500 mg / 500 ml normal saline or Placebo (500 ml normal saline) will be given to the patient by IV infusion for 3 hours as one dose of the week by 3-3-3-3 dosing regimen (i.e. 3 doses in the 1st week, 3 doses in the 2nd week, 3 doses in the 3rd week and 3 doses in the 4th week). All patients in both arms will then receive PG2 by the same 3-3-3-3 dosing regimen in the second treatment cycle as an assurance to the participating patients that they will receive and potentially benefit from compassionate use of PG2 for at least one treatment cycle.
Detailed Description:

This is a trial to evaluate use of PG2 for fatigue improvement in advanced cancer patients who are under standard palliative care at hospice setting and have no further curative options available. Only patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. All patients will continue the standard palliative care (SPC) during this study.

The main aim of this trial is to compare improvement of patient's fatigue status between patients with or without PG2 treatment. Patient's fatigue status will be assessed by the Brief Fatigue Inventory-Taiwanese (BFI-T) Form. Each patient's fatigue improvement response will be defined as an improvement in the mean fatigue scores by at least 10% from baseline. Other quality of life parameters will be measured by the 11 questions (SS11) of the EORTC QLQ-C30 and by Karnofsky performance scale. Patient's weight change and its related c-reactive protein will be followed. There are two study arms in this trial: 1) the PG2 plus SPC arm; and 2) the Placebo plus SPC arm.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed the informed consent form
  • ≧ 18 years old
  • Have locally advanced or metastatic cancer or inoperable advanced cancer
  • Under standard palliative care (SPC) at hospice setting and have no further curative options available
  • BFI fatigue score ≧ 4
  • Women with childbearing potential must use contraception
  • Life expectancy of at least 3 months as determined by the investigator
  • Willing and able to complete quality of life questionnaires

Exclusion Criteria:

  • Pregnant or breast-feeding females
  • Uncontrolled systemic disease such as active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus
  • Take central nervous system stimulators such as Methylphenidate within last 30 days
  • In other investigational drug trials within last 30 days
  • Karnofsky performance scores < 30%
  • Diagnosed as dying status
  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: NCT00523107

Locations
Taiwan
Mackay Memorial Hospital
Tamshui, Taipei, Taiwan
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
Principal Investigator: Yuen-Liang Lai, M.D. Mackay Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00523107     History of Changes
Other Study ID Numbers: PH-CP012
Study First Received: August 21, 2007
Last Updated: June 12, 2009
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Keywords provided by PhytoHealth Corporation:
Fatigue
Standard Palliative Care
PG2
QLQ-C30
Compassionate

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014