Clinical trial NCT01720563: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer-related Fatigue
Keywords: Cancer-related fatigue
astragalus polysaccharides
concurrent chemoradiotherapy
squamous cell carcinoma of head and neck
Lead sponsor: PhytoHealth Corporation
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Fatigue status by Brief Fatigue Inventory (BFI)
timeFrame: 8 weeks
Secondary outcomes:
measure: Symptoms/Quality of Life Assessments by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 and H&N 35 questionnaires
timeFrame: 8 weeks
measure: Karnofsky Performance Scale (KPS)
timeFrame: 8 weeks
measure: Incidences of myelosuppression
timeFrame: 8 weeks
measure: Serum inflammatory cytokines and c-reactive protein
timeFrame: 8 weeks
measure: Weight loss
timeFrame: 8 weeks
measure: Incidence of adverse events
timeFrame: 8 weeks
measure: Tumor response
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Hung-Ming HM Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: