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

NCT00523107 | Completed Phase 2

• 1 other identifier: PH-CP012
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue

Keywords

Fatigue; Standard Palliative Care; PG2; QLQ-C30; Compassionate

Outcome Measures

Primary Outcomes (1)

• 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.

  within and between each cycle (4 weeks)

Secondary Outcomes (6)

• The fatigue improvement response rate among patients within and between cycles (by BFI-T)

  within and between cycles (4 weeks)

• The fatigue improvement by multiple BFI-T score levels among patients between two study arms

  within and between cycles (4 weeks)

• The mean fatigue scores change from baseline among patients within and between cycles (by BFI-T)

  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

  within and between cycles (4 weeks)

• Karnofsky performance score

  within and between cycles (4 weeks)

Study Arms (2)

PG2

EXPERIMENTAL

PG2 500 mg / 500 ml normal saline will be given t.i.w for 8 weeks.

Drug: PG2

Placebo

PLACEBO COMPARATOR

500 ml normal saline will be given t.i.w 1-4 weeks, then PG2 500 mg / 500 ml normal saline will be given 5-8 weeks.

Drug: PG2; Drug: Placebo

Interventions

PG2 DRUG

PG2 500 mg / 500 ml normal saline t.i.w. per week

PG2; Placebo

Placebo DRUG

500 ml normal saline t.i.w. per week

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (1)

Mackay Memorial Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuen-Liang Lai, M.D.

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 30, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

TW (1)