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
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- PhytoHealth Corporation
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Fatigue status by Brief Fatigue Inventory (BFI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Control
Placebo
Intervention: Placebo (Drug)
Control
Placebo
Intervention: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks (Procedure)
Treatment
Astragalus polysaccharides 500 mg
Intervention: Astragalus polysaccharides 500 mg (Drug)
Treatment
Astragalus polysaccharides 500 mg
Intervention: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks (Procedure)
Outcomes
Primary Outcomes
Fatigue status by Brief Fatigue Inventory (BFI)
Time Frame: 8 weeks
Secondary Outcomes
- 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)