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

This study is currently recruiting participants.
Verified October 2012 by PhytoHealth Corporation
Sponsor:
Information provided by (Responsible Party):
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT01720563
First received: October 29, 2012
Last updated: April 18, 2013
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer-related Fatigue
 Drug: Astragalus polysaccharides 500 mg
Drug: Placebo
Procedure: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PhytoHealth Corporation:

Primary Outcome Measures:
  • Fatigue status by Brief Fatigue Inventory (BFI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Karnofsky Performance Scale (KPS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Incidences of myelosuppression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Serum inflammatory cytokines and c-reactive protein [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Tumor response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Placebo
 Drug: 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
Experimental: Treatment
Astragalus polysaccharides 500 mg
 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
Other Name: PG2 Injection 500 mg
Procedure: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720563

Contacts
Contact: Hsiao-Chien HC Cheng, MS 886-2-25453697 ext 334 hccheng@phytohealth.com.tw

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Principal Investigator: Hung-Ming HM Wang, MD            
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
Principal Investigator: Hung-Ming HM Wang, MD Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: PhytoHealth Corporation
ClinicalTrials.gov Identifier: NCT01720563     History of Changes
Other Study ID Numbers: PH-CP021
Study First Received: October 29, 2012
Last Updated: April 18, 2013
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by PhytoHealth Corporation:
Cancer-related fatigue
astragalus polysaccharides
concurrent chemoradiotherapy
squamous cell carcinoma of head and neck

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Fatigue
Laryngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Signs and Symptoms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
 Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Cisplatin
Leucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013