- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01720563
A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy
November 23, 2023 updated by: PhytoHealth Corporation
A Phase II Double-blind and Randomized Trial Comparing Concurrent Chemoradiotherapy Plus PG2 Injection Versus Concurrent Chemoradiotherapy Plus Placebo in Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma
Eighty to 90% of SCCHN (squamous cell carcinoma of head and neck) patients in Taiwan were betel quid chewers.
Thirty to 40% of them experienced mucositis World Health Organization (WHO) grade 3 from cisplatin/flurouracil (FU) in neoadjuvant chemotherapy setting.
This was higher than the 8-11% reported in the Western populations and was related to oral submucous fibrosis from betel quid chewing.Severer toxicities, esp.
mucositis, could be anticipated in patients of betel quid chewing treated by concurrent chemoradiotherapy (CCRT) with cisplatin/FU.PG2 Injection is proved to be safe for clinical use and is effective in stimulating the recovery of hematopoiesis and immunity from chemotherapy-induced myelosuppression.
It also improved the Quality of Life, especially in fatigue, among advanced cancer patients.
This study will be investigated the effect of PG2 Injection in relieving the adverse events of concurrent chemoradiotherapy, such as fatigue, myelosuppression, mucositis, body weight loss, and even the compliance of radiotherapy and chemotherapy in treatment of patients with advanced pharyngeal or laryngeal SCCHN.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taoyuan, Taiwan, 333
- Chang Gung memorial hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histological confirmation of squamous cell carcinoma
- Primary tumor site in the head and neck area
- Stage III or IV disease
- Measurable locoregional disease and no distant metastasis
- No prior cancer treatment
- 20-70 years old
- KPS ≧ 70
- Adequate bone marrow, liver, and renal function
- Fed with gastric tubes but without intestinal malabsorption or obstruction
- Not pregnancy and use a reliable contraceptive method during the study
- Signed informed consent
- Willing and able to complete quality of life questionnaires
Exclusion Criteria:
- Decompensated liver function
- Serious concomitant illness that might be aggravated by chemotherapy
- Active cardiac disease preceding the entry into the study
- Severe uncontrolled hypertension
- Uncontrolled infection
- History of other malignancy
- Pregnant or breast feeding
- Receiving other concomitant chemotherapy, radiotherapy or any other anticancer treatment
- Mental status not suitable for clinical trials
- Intestinal obstruction or malabsorption.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Placebo
|
500 ml saline, t.i.w.
via i.v.
infusion for 2.5-3.5 hours during the CCRT
|
Experimental: Treatment
Astragalus polysaccharides 500 mg
|
PG2 (500 mg in 500 ml saline), t.i.w.
via i.v.
infusion for 2.5-3.5 hours during the CCRT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fatigue status by Brief Fatigue Inventory (BFI)
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight loss
Time Frame: 8 weeks
|
8 weeks
|
Symptoms/Quality of Life Assessments by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 and H&N 35 questionnaires
Time Frame: 8 weeks
|
8 weeks
|
Karnofsky Performance Scale (KPS)
Time Frame: 8 weeks
|
8 weeks
|
Incidences of myelosuppression
Time Frame: 8 weeks
|
8 weeks
|
Serum inflammatory cytokines and c-reactive protein
Time Frame: 8 weeks
|
8 weeks
|
Incidence of adverse events
Time Frame: 8 weeks
|
8 weeks
|
Tumor response
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hung-Ming HM Wang, MD, Chang Gung memorial hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
October 29, 2012
First Submitted That Met QC Criteria
October 31, 2012
First Posted (Estimated)
November 2, 2012
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Fatigue
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Leucovorin
- Tegafur
Other Study ID Numbers
- PH-CP021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer-related Fatigue
-
Buddhist Tzu Chi General HospitalRecruitingGynecologic Cancer | Cancer-related FatigueTaiwan
-
Taipei Medical UniversityNot yet recruitingCancer Related Fatigue
-
German Cancer Research CenterNational Center for Tumor Diseases, HeidelbergRecruitingCancer-related FatigueGermany
-
German Cancer Research CenterGerman Research Foundation; Wuerzburg University Hospital; Baden-Württemberg...RecruitingCancer-related FatigueGermany
-
Taichung Tzu Chi HospitalNot yet recruitingCancer-related Fatigue
-
University of CalgaryCanadian Cancer Society (CCS)Completed
-
German Cancer Research CenterUniversity Hospital HeidelbergWithdrawnCancer-related Fatigue
-
UConn HealthSusan G. Komen Breast Cancer Foundation; Hollfelder foundationTerminatedCancer-related FatigueUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Center for Complementary and Integrative...CompletedCancer Related FatigueUnited States
-
National Cancer Center, KoreaSamsung Medical Center; Seoul National University Hospital; Korea University...UnknownCancer-related FatigueKorea, Republic of
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States