Cancer-related Fatigue
Conditions
Keywords
Cancer-related fatigue, astragalus polysaccharides, concurrent chemoradiotherapy, squamous cell carcinoma of head and neck
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.
Interventions
PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
DRUGPlacebo
500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
PROCEDUREConcurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
Sponsors
PhytoHealth Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue status by Brief Fatigue Inventory (BFI) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Karnofsky Performance Scale (KPS) | 8 weeks |
| Incidences of myelosuppression | 8 weeks |
| Serum inflammatory cytokines and c-reactive protein | 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 |
| Incidence of adverse events | 8 weeks |
| Tumor response | 8 weeks |
| Weight loss | 8 weeks |
Countries
Taiwan
Outcome results
None listed