Fatigue Clinical Trial
Official title:
PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04959214 -
The Effect Of Progressıve Relaxatıon Exercıses
|
N/A | |
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Completed |
NCT04531891 -
Utility and Validity of a High-intensity, Intermittent Exercise Protocol
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT04960865 -
Kinesio Taping and Calf Muscle Fatigue
|
N/A | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT06421233 -
The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
|
N/A | |
Active, not recruiting |
NCT05344183 -
Immediate and Short-term Effects of Low-level Laser
|
N/A | |
Completed |
NCT04716049 -
Effectiveness of Recovery Protocols in Elite Professional Young Soccer Players
|
N/A | |
Completed |
NCT00060398 -
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05241405 -
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer
|
N/A | |
Active, not recruiting |
NCT06074627 -
Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes
|
N/A | |
Completed |
NCT03943212 -
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis
|
N/A | |
Recruiting |
NCT05567653 -
Effects of Probiotics on Gut Microbiota, Endocannabinoid and Immune Activation and Symptoms of Fatigue in Dancers
|
N/A | |
Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
Not yet recruiting |
NCT05863897 -
e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury
|
N/A | |
Not yet recruiting |
NCT05002894 -
Effect of Pilates Exercises On Fatigue In Post Menopausal Women
|
N/A | |
Recruiting |
NCT04091789 -
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
|
Phase 2 | |
Completed |
NCT02911649 -
Reducing Sedentary Behaviour With Technology
|
N/A | |
Completed |
NCT02321358 -
Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors
|
N/A |