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

Primary Purpose

Cancer-related Fatigue

Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Astragalus polysaccharides 500 mg
Placebo
Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
Sponsored by
PhytoHealth Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer-related Fatigue focused on measuring Cancer-related fatigue, astragalus polysaccharides, concurrent chemoradiotherapy, squamous cell carcinoma of head and neck

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

Placebo

Astragalus polysaccharides 500 mg

Outcomes

Primary Outcome Measures

Fatigue status by Brief Fatigue Inventory (BFI)

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
Karnofsky Performance Scale (KPS)
Incidences of myelosuppression
Serum inflammatory cytokines and c-reactive protein
Weight loss
Incidence of adverse events
Tumor response

Full Information

First Posted
October 29, 2012
Last Updated
June 13, 2022
Sponsor
PhytoHealth Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01720563
Brief Title
A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy
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 Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Change study drug dosage form
Study Start Date
December 2012 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhytoHealth Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Fatigue
Keywords
Cancer-related fatigue, astragalus polysaccharides, concurrent chemoradiotherapy, squamous cell carcinoma of head and neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Astragalus polysaccharides 500 mg
Intervention Type
Drug
Intervention Name(s)
Astragalus polysaccharides 500 mg
Other Intervention Name(s)
PG2 Injection 500 mg
Intervention Description
PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
Intervention Type
Procedure
Intervention Name(s)
Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
Primary Outcome Measure Information:
Title
Fatigue status by Brief Fatigue Inventory (BFI)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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
Title
Karnofsky Performance Scale (KPS)
Time Frame
8 weeks
Title
Incidences of myelosuppression
Time Frame
8 weeks
Title
Serum inflammatory cytokines and c-reactive protein
Time Frame
8 weeks
Title
Weight loss
Time Frame
8 weeks
Title
Incidence of adverse events
Time Frame
8 weeks
Title
Tumor response
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Ming HM Wang, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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