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

Cancer-related Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01720563
• Other study ID #: PH-CP021
• Status: Terminated
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: April 2014

Study information

• Verified date: November 2023
• Source: PhytoHealth Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Carcinoma
• Carcinoma, Squamous Cell
• Fatigue
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
PhytoHealth Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue status by Brief Fatigue Inventory (BFI)		8 weeks
Secondary	Symptoms/Quality of Life Assessments by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 and H&N 35 questionnaires		8 weeks
Secondary	Karnofsky Performance Scale (KPS)		8 weeks
Secondary	Incidences of myelosuppression		8 weeks
Secondary	Serum inflammatory cytokines and c-reactive protein		8 weeks
Secondary	Weight loss		8 weeks
Secondary	Incidence of adverse events		8 weeks
Secondary	Tumor response		8 weeks