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

NCT01720563 | Terminated Phase 2

• 1 other identifier: PH-CP021
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer-related Fatigue

Keywords

Cancer-related fatigue; astragalus polysaccharides; concurrent chemoradiotherapy; squamous cell carcinoma of head and neck

Outcome Measures

Primary Outcomes (1)

• Fatigue status by Brief Fatigue Inventory (BFI)

  8 weeks

Secondary Outcomes (7)

• 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

• Weight loss

  8 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo

Drug: Placebo; Procedure: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks

Treatment

EXPERIMENTAL

Astragalus polysaccharides 500 mg

Drug: Astragalus polysaccharides 500 mg; Procedure: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks

Interventions

Astragalus polysaccharides 500 mg DRUG

PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT

Also known as: PG2 Injection 500 mg

Treatment

Placebo DRUG

500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT

Control

Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks PROCEDURE

Control; Treatment

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Chemoradiotherapy; Cisplatin; Tegafur; Uracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Fluorouracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hung-Ming HM Wang, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 2, 2012
• Study Start: December 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

TW (1)