Clinical trial NCT02077621: Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer
Official title: The Phase II Clinical Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cancer
Surgery
Fatigue
Keywords: cancer-related fatigue
Palliative Abdominal Surgery
HRQL
Lead sponsor: PhytoHealth Corporation
Sponsor class: INDUSTRY
First posted: 2014-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PG2 has been approved in Taiwan to treat cancer-related fatigue for advanced cancer patients. The primary objective of this study is to evaluate the efficacy of PG2 on fatigue relief in patients undergoing palliative abdominal surgery for cancer. The secondary endpoints, including the length of hospital stay, postoperative complications, HRQL, inflammatory biomarkers, the duration of antibiotic therapy, mortality during the hospital stay, weight loss and body composition, will be evaluated among these patients.

Detailed description: This will be a double-blind, randomized, and placebo-controlled study. At least 40 evaluable patients who are scheduled for palliative abdominal surgery for cancer will be randomly assigned to the control or treatment group. Each group will have at least 20 patients and be treated as follows: 1) control group: patients will accept placebo 1 dose a day (POD-1) before surgery and 1 dose a day for 3 days after surgery (POD+0 to POD+2); 2) treatment group: patients will accept PG2 1 dose a day (POD-1) before surgery and 1 dose a day for 3 days after surgery (POD+0 to POD+2).

Eligibility criteria: Inclusion Criteria:

* Patients who have cancer and are scheduled for palliative abdominal surgery for cancer
* Age \> 20 years older
* Patients who signed the informed consent form

Exclusion Criteria:

* Patients, at screening, has levels greater than 2.5 times the upper limit of normal liver function of alanine aminotransferase or aspartate aminotransferase.
* Patients has a severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2.5 times the upper limit of normal for range); or the subject is on dialysis.
* Patients have ongoing infection, respiratory tract dysfunction, cardiac dysfunction or immune disorder that, in the opinion of the investigator, may interfere with conduct of the study.
* Patients who are not suitable for undergoing surgery (e.g. congenital hemostatic disorders) by the investigator's judgment.
* Patients have enrolled or have not yet completed other investigational drug trials within 1 month before screening.
* Female patients are pregnant or breast-feeding.
* Patients who require preoperative nutritional support
* Patients with serious comorbidities (American Society of Anesthesiologists Risk Class of 4 or 5).
* Patients who is unwilling or unable to answer the quality of life questionnaires i.e. the BFI-T and EORTC QLQ-C30.

Primary outcomes:
measure: change from baseline fatigue status
timeFrame: a day before surgery and day 1,2,7,28,56,84 after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 13 weeks
measure: Postoperative complications
timeFrame: 13 weeks
measure: Health-related Quality of Life (HRQL)
timeFrame: a day before surgery and for day 7,28,56,84 after surgery
measure: Inflammatory biomarkers: Serum IFN-r, IL-1b, IL-4, IL-6, IL-10 and TNF-a
timeFrame: Before operation and on day 1, and day 7 after operation
measure: The duration of antibiotic therapy
timeFrame: 13 weeks
measure: Mortality during the hospital stay
timeFrame: 13 weeks
measure: Weight loss
timeFrame: 13 weeks
measure: Body composition
timeFrame: a day before surgery and for day 28 after surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Ming Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: