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

PhytoHealth

Status and phase: Terminated; Phase 2

Conditions: Cancer-related Fatigue

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01720563

PH-CP021

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

17 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

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

Treatment

Experimental group

Description:

Astragalus polysaccharides 500 mg

Treatment:

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

Drug: Astragalus polysaccharides 500 mg