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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer-related Fatigue

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence of adverse events |  | 8 weeks | 
| Tumor response |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer-related fatigue, astragalus polysaccharides, concurrent chemoradiotherapy, squamous cell carcinoma of head and neck