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

Phase 2

Terminated

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

• Registration Number: NCT01720563
• Lead Sponsor: PhytoHealth Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Study Start: 2012-12
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks	Placebo
Treatment	Astragalus polysaccharides 500 mg	Astragalus polysaccharides 500 mg
Control	Placebo	Placebo
Treatment	Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks	Astragalus polysaccharides 500 mg

Primary Outcome Measures

Name	Time	Method
Fatigue status by Brief Fatigue Inventory (BFI)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Karnofsky Performance Scale (KPS)	8 weeks
Serum inflammatory cytokines and c-reactive protein	8 weeks
Tumor response	8 weeks
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
Incidences of myelosuppression	8 weeks
Incidence of adverse events	8 weeks

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan