A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy

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: Cancer-related Fatigue
• Intervention / Treatment: Drug: Placebo; Procedure: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks; Drug: Astragalus polysaccharides 500 mg

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Placebo	Drug: Placebo; 500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT; Procedure: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
Experimental: Treatment; Astragalus polysaccharides 500 mg	Procedure: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks; Drug: 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: PG2 Injection 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fatigue status by Brief Fatigue Inventory (BFI)	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight loss	8 weeks
Symptoms/Quality of Life Assessments by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 and H&N 35 questionnaires	8 weeks
Karnofsky Performance Scale (KPS)	8 weeks
Incidences of myelosuppression	8 weeks
Serum inflammatory cytokines and c-reactive protein	8 weeks
Incidence of adverse events	8 weeks
Tumor response	8 weeks

Collaborators and Investigators

• Sponsor: PhytoHealth Corporation
• Investigators: Principal Investigator: Hung-Ming HM Wang, MD, Chang Gung Memorial Hospital

Study record dates

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): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: squamous cell carcinoma of head and neck; Cancer-related fatigue; concurrent chemoradiotherapy; astragalus polysaccharides
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Fatigue; Carcinoma, Squamous Cell; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Micronutrients; Protective Agents; Antidotes; Vitamin B Complex; Vitamins; Leucovorin; Tegafur
• Other Study ID Numbers: PH-CP021