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Cancer-related FatiguePhase 2NCT01720563

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

A Phase 2 study testing Astragalus polysaccharides 500 mg and Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks in people with Cancer-related Fatigue, run by PhytoHealth Corporation at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Cancer-related Fatigue
What is being tested?
Astragalus polysaccharides 500 mg and Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteTaiwan
Study dates
Dec 2012to Apr 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

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

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.

Being tested
Astragalus polysaccharides 500 mg, Placebo, Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
Keywords
Cancer-related fatigue, astragalus polysaccharides, concurrent chemoradiotherapy, squamous cell carcinoma of head and neck
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Astragalus polysaccharides 500 mgDrug

    Also called PG2 Injection 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

  • PlaceboDrug

    500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT

  • Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeksProcedure or surgery

Study groups in NCT01720563
Study groupRoleWhat they receive
ControlPlacebo comparatorPlacebo
Receives: Drug: Placebo; Procedure: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
TreatmentExperimentalAstragalus polysaccharides 500 mg
Receives: Drug: Astragalus polysaccharides 500 mg; Procedure: Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue status by Brief Fatigue Inventory (BFI)

    Measured: 8 weeks

Secondary outcomes (7)

  1. Symptoms/Quality of Life Assessments by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 and H&N 35 questionnaires

    Measured: 8 weeks

  2. Karnofsky Performance Scale (KPS)

    Measured: 8 weeks

  3. Incidences of myelosuppression

    Measured: 8 weeks

  4. Serum inflammatory cytokines and c-reactive protein

    Measured: 8 weeks

  5. Weight loss

    Measured: 8 weeks

  6. Incidence of adverse events

    Measured: 8 weeks

  7. Tumor response

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionApr 2014
  4. Study completionApr 2014

Why it stopped: Change study drug dosage form

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01720563
Sponsor's protocol ID
PH-CP021
Status last verified
Jun 2025
First submitted
29 Oct 2012
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Astragalus polysaccharides 500 mg and Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks in people with Cancer-related Fatigue, run by PhytoHealth Corporation at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Change study drug dosage form). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue status by Brief Fatigue Inventory (BFI) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01720563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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