CompletedPhase 4

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

Taiwan323 participantsStarted 2012-11

Plain-language 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 different doses of PG2 treatment 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(European Organization) for Research and Treatment of Cancer 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed the informed consent form * ≧ 20 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 score ≧ 4 * 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 * Uncontrolled systemic disease * Take central nervous system stimulators within 30 days before screening * Have enrolled or have not yet completed other investigational drug trials within 30 days before screening * Karnofsky Performance Scores less than 30 % * Diagnosed as dying status

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fatigue Improvement Response Rate

Timeframe: 4 weeks

Trial details

NCT IDNCT01720550

SponsorPhytoHealth Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06

View on ClinicalTrials.gov More Cancer-related Fatigue trials