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

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ClinicalTrials.gov Identifier: NCT01720563
Recruitment Status : Terminated (Change study drug dosage form)
First Posted : November 2, 2012
Last Update Posted : November 4, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2012
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Control
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

Outcome Measures

Primary Outcome Measures :
  1. Fatigue status by Brief Fatigue Inventory (BFI) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Karnofsky Performance Scale (KPS) [ Time Frame: 8 weeks ]
  3. Incidences of myelosuppression [ Time Frame: 8 weeks ]
  4. Serum inflammatory cytokines and c-reactive protein [ Time Frame: 8 weeks ]
  5. Weight loss [ Time Frame: 8 weeks ]
  6. Incidence of adverse events [ Time Frame: 8 weeks ]
  7. Tumor response [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720563

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

Responsible Party: PhytoHealth Corporation
ClinicalTrials.gov Identifier: NCT01720563     History of Changes
Other Study ID Numbers: PH-CP021
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Signs and Symptoms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents