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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Fatigue status by Brief Fatigue Inventory (BFI)
Time frame: 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
Karnofsky Performance Scale (KPS)
Time frame: 8 weeks
Incidences of myelosuppression
Time frame: 8 weeks
Serum inflammatory cytokines and c-reactive protein
Time frame: 8 weeks
Weight loss
Time frame: 8 weeks
Incidence of adverse events
Time frame: 8 weeks
Tumor response
Time frame: 8 weeks
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