Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer

• Sponsor: PhytoHealth Corporation (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT02077621
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 82
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Surgery; Fatigue	Drug: PG2; Drug: Placebo	Phase 2

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Phase II Clinical Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer
• Anticipated Study Start Date: Feb 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PG2 Treatment Group: PG2 (500 mg in 500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery	Drug: PG2; Powder for Injection, 500 mg PG2/500 ml normal saline; Other Names: PG2 injection 500mg
Placebo Comparator: Placebo Control group: Placebo (500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery	Drug: Placebo; 500 mL normal saline

Outcome Measures

Primary Outcome Measures

1. change from baseline fatigue status [a day before surgery and day 1,2,7,28,56,84 after surgery]

   qustionnaires

Secondary Outcome Measures

1. Length of hospital stay [13 weeks]

2. Postoperative complications [13 weeks]

   patients were observed for surgical and nonsurgical complication

3. Health-related Quality of Life (HRQL) [a day before surgery and for day 7,28,56,84 after surgery]

4. Inflammatory biomarkers: Serum IFN-r, IL-1b, IL-4, IL-6, IL-10 and TNF-a [Before operation and on day 1, and day 7 after operation]

5. The duration of antibiotic therapy [13 weeks]

6. Mortality during the hospital stay [13 weeks]

7. Weight loss [13 weeks]

   patients will be measured during follow-up period

8. Body composition [a day before surgery and for day 28 after surgery]

   such as protein, mineral, body fat mass

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• PhytoHealth Corporation

Investigators

• Principal Investigator: Jin-Ming Wu, M.D., National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PhytoHealth Corporation
• ClinicalTrials.gov Identifier: NCT02077621
• Other Study ID Numbers: PH-CP020
• First Posted: Mar 4, 2014
• Last Update Posted: Jun 15, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by PhytoHealth Corporation: cancer-related fatigue; Palliative Abdominal Surgery; HRQL
• Additional relevant MeSH terms: Fatigue

Study Results

No Results Posted as of Jun 15, 2022