CancerPhase 2NCT02077621
Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer
A Phase 2 study testing PG2 in people with Cancer and Surgery, run by PhytoHealth Corporation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- What is being tested?
- PG2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2014to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have cancer and are scheduled for palliative abdominal surgery for cancer
- Age > 20 years older
- Patients who signed the informed consent form
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Phase II Clinical Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer
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.
Read the 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).
- Being tested
- PG2, Placebo
- Keywords
- cancer-related fatigue, Palliative Abdominal Surgery, HRQL
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG2Drug
Also called PG2 injection 500mg
Powder for Injection, 500 mg PG2/500 ml normal saline
PlaceboDrug
500 mL normal saline
| Study group | Role | What they receive |
|---|---|---|
| PG2 | Experimental | 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 Receives: Drug: PG2 |
| Placebo | Placebo comparator | Control group:
Placebo (500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline fatigue status
qustionnaires
Measured: a day before surgery and day 1,2,7,28,56,84 after surgery
Secondary outcomes (8)
Length of hospital stay
Measured: 13 weeks
Postoperative complications
patients were observed for surgical and nonsurgical complication
Measured: 13 weeks
Health-related Quality of Life (HRQL)
Measured: a day before surgery and for day 7,28,56,84 after surgery
Inflammatory biomarkers: Serum IFN-r, IL-1b, IL-4, IL-6, IL-10 and TNF-a
Measured: Before operation and on day 1, and day 7 after operation
The duration of antibiotic therapy
Measured: 13 weeks
Mortality during the hospital stay
Measured: 13 weeks
Weight loss
patients will be measured during follow-up period
Measured: 13 weeks
Body composition
such as protein, mineral, body fat mass
Measured: a day before surgery and for day 28 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startFeb 2014 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020
Why it stopped: Study reevaluation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin-Ming Wu, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077621
- Sponsor's protocol ID
- PH-CP020
- Status last verified
- Jun 2025
- First submitted
- 24 Feb 2014
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase II Clinical Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer
- ClinicalTrials.gov ID
- NCT02077621
- Acronym / sponsor ID
- PH-CP020
- Keywords
- cancer-related fatigue, Palliative Abdominal Surgery, HRQL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study reevaluation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2014 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PG2 | Experimental | Drug: PG2Treatment Group: PG2 (500 mg in 500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery |
| Placebo | Placebo comparator | Drug: PlaceboControl group: Placebo (500 ml saline), 1 dose a day before surgery and 1 dose a day for 3 days after surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have cancer and are scheduled for palliative abdominal surgery for cancer
- Age > 20 years older
- Patients who signed the informed consent form
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG2Also: PG2 injection 500mgPowder for Injection, 500 mg PG2/500 ml normal saline | Drug | PG2 |
| Placebo500 mL normal saline | Drug | Placebo |
Primary outcome
change from baseline fatigue status
Time frame: a day before surgery and day 1,2,7,28,56,84 after surgery
qustionnaires
8 secondary outcomes
Length of hospital stay
Time frame: 13 weeks
Postoperative complications
Time frame: 13 weeks
Health-related Quality of Life (HRQL)
Time frame: a day before surgery and for day 7,28,56,84 after surgery
Inflammatory biomarkers: Serum IFN-r, IL-1b, IL-4, IL-6, IL-10 and TNF-a
Time frame: Before operation and on day 1, and day 7 after operation
The duration of antibiotic therapy
Time frame: 13 weeks
Mortality during the hospital stay
Time frame: 13 weeks
Weight loss
Time frame: 13 weeks
Body composition
Time frame: a day before surgery and for day 28 after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Ming Wu, M.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG2 in people with Cancer and Surgery, run by PhytoHealth Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline fatigue status (time frame: a day before surgery and day 1,2,7,28,56,84 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.