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Head and Neck NeoplasmPhase 1NCT05590650

A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients

A Phase 1 study testing SZKJT(San-Zhong-Kui-Jian-Tang) in people with Head and Neck Neoplasm and Chemoradiotherapy, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to learn about the clinical efficacy of San-Zhong-Kui-Jian-Tang (SZKJT), a formula of Chinese medicine in head and neck cancer patients receiving concurrent chemoradiotherapy (CCRT) treatments. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Head and Neck Neoplasm, Chemoradiotherapy
What is being tested?
SZKJT(San-Zhong-Kui-Jian-Tang)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteTaiwan
Study dates
7 Jul 2018to 25 Dec 2020
Phase
Phase 1
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged from 20- to 65-year-old;
  • firstly diagnosed as head and neck cancer with stage II, III or IV;
  • adjuvant therapy with chemotherapy of Cisplatin or combined with radiotherapy after surgery;
  • or chemotherapy of Cisplatin for those without surgery;
  • wiliness to sign inform consent.

Who cannot join

  • pregnancy;
  • non-Squamous-cell carcinoma;
  • secondary cancer or Carcinoma in situ in 5 years;
  • any evidence of metastasis;
  • abnormality of liver, kidney or bone marrow functions before treatments;
  • unstable vital signs;
Show all 9Show fewer
  • episode of acute infection;
  • unclear consciousness for inform consent;
  • receiving other herbal, complementary or acupuncture therapy.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • China Medical University Hospital

    Taichung, 404327

Other trials in Taiwan

About this study

The goal of this clinical trial is to learn about the clinical efficacy of San-Zhong-Kui-Jian-Tang (SZKJT), a formula of Chinese medicine in head and neck cancer patients receiving concurrent chemoradiotherapy (CCRT) treatments. The main questions it aims to answer are:

  • Can SZKJT improve the completion rate of CCRT?
  • Can SZKJT reduce the adverse effects of CCRT?
  • How SZKJT affect the quality of life in the patients receiving CCRT
  • How about the safety of using SZKJT in the patients receiving CCRT

Participants will be asked to:

  • take SZKJT for 9 weeks during the whole CCRT course
  • take questionnaires of quality of life
Read the detailed description

San-Zhong-Kui-Jian-Tang (SZKJT) is originated from the Secret Treasure of the Orchid Chamber written by Gao Li (AC1180 - 1251). SZKJT contains 16 herbs to treat abnormal swelling or nodules. In the theory of Chinese medicine, SZKJT can clear heat and resolve toxin, which leads to disperse swelling and binds in nodules.

The purpose of this study is to explore the clinical efficacy and safety of SZKJT in improving the completion rate of concurrent chemoradiotherapy (CCRT) in patients with head and neck cancer, and to evaluate the prevention and treatment effects of SZKJT on the side effects of chemoradiotherapy, as well as the improvement of quality of life.

The primary endpoint of the study is the completion rate of CCRT under SZKJT treatment. The secondary endpoints are adverse effects of CTCAE, body constitution questionnaire (BCQ) and the EORTC core quality of life questionnaire (QLQ-C30). Liver and kidney functions are considered as well for adverse effects of SZKJT. We hypothesized that additional SZKJT with CCRT might improve completion rate of CCRT and reduce severity of adverse effects of CCRT.

Being tested
SZKJT(San-Zhong-Kui-Jian-Tang)
Keywords
Head and Neck Neoplasms;, Chemoradiotherapy, Complementary Therapies, Medicine, Chinese Traditional
Medical subject headings
Head and Neck Neoplasms

What participants receive

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

  • SZKJT(San-Zhong-Kui-Jian-Tang)Drug

    Also called Product from Kaiser Pharmaceutical Co. Ltd.

    The SZKJT samples were made and packed by Kaiser Pharmaceutical Co. Ltd. with lot number of 2019023247.

Study groups in NCT05590650
Study groupRoleWhat they receive
SZKJT groupExperimentalPatients who meet the inclusion criteria and agree to receive concomitant treatment with SZKJT.
Receives: Drug: SZKJT(San-Zhong-Kui-Jian-Tang)

What is being measured

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

  1. The completion rate

    We counted the percentage rate of those who achieved and did not reach the CCRT course.

    Measured: We will do an assessment at the seventh week of CCRT. Patients who had completed a seven-week course of treatment and had a cumulative dose of cisplatin greater than 200 mg per m2 will be considered the completion group.

Secondary outcomes (5)

  1. The adverse effects

    We apply Common Terminology Criteria for Adverse Events (CTCAE) to assess the adverse effects of CCRT.

    Measured: The assessment is performed at the eighth week.

  2. The change in Quality of Life

    We assess the patients' quality of life by using the European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire QLQ-C30.

    Measured: The questionnaire is assessed at the baseline and the eighth week.

  3. The Change of Constitutions of traditional Chinese medicine

    We assess the patients' constitutions of traditional Chinese medicine by using Body Constitution Questionnaire (BCQ).

    Measured: The questionnaire is assessed at the baseline and the eighth week.

  4. The change of liver function

    We monitor the liver function of the patients by blood chemistry analysis. The levels of Alanine transaminase (ALT) and Aspartate transaminase (AST) are recorded as units per liter.

    Measured: The lab data of biochemistry analysis is collected at the baseline and the eighth week.

  5. The change of renal function

    We monitor the renal function of the patients by blood chemistry analysis. The levels of blood urine nitrogen (mg/dL) and creatinine (mg/dL) are recorded. Glomerular filtration rate (GFR) is estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021).

    Measured: The lab data of biochemistry analysis is collected at the baseline and the eighth week.

Timeline

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

  1. First posted21 Oct 2022
  2. Study start7 Jul 2018
  3. Primary completion14 Jun 2020
  4. Study completion25 Dec 2020

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 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05590650
Sponsor's protocol ID
CMUH106-REC3-149
Status last verified
Oct 2022
First submitted
16 Oct 2022
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.

    PubMed 15128894

  • Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.

    PubMed 15128893

  • Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefebvre JL. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck. 2005 Oct;27(10):843-50. doi: 10.1002/hed.20279.

    PubMed 16161069

  • Cooper JS, Zhang Q, Pajak TF, Forastiere AA, Jacobs J, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Lustig R, Ensley JF, Thorstad W, Schultz CJ, Yom SS, Ang KK. Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1198-205. doi: 10.1016/j.ijrobp.2012.05.008. Epub 2012 Jun 30.

    PubMed 22749632

  • Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, Glisson B, Trotti A, Ridge JA, Chao C, Peters G, Lee DJ, Leaf A, Ensley J, Cooper J. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003 Nov 27;349(22):2091-8. doi: 10.1056/NEJMoa031317.

    PubMed 14645636

  • Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008.

    PubMed 12506176

  • Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8.

    PubMed 12742264

  • Russo G, Haddad R, Posner M, Machtay M. Radiation treatment breaks and ulcerative mucositis in head and neck cancer. Oncologist. 2008 Aug;13(8):886-98. doi: 10.1634/theoncologist.2008-0024. Epub 2008 Aug 13.

    PubMed 18701763

  • Robertson AG, Robertson C, Perone C, Clarke K, Dewar J, Elia MH, Hurman D, MacDougall RH, Yosef HM. Effect of gap length and position on results of treatment of cancer of the larynx in Scotland by radiotherapy: a linear quadratic analysis. Radiother Oncol. 1998 Aug;48(2):165-73. doi: 10.1016/s0167-8140(98)00038-3.

    PubMed 9783888

  • Robertson C, Robertson AG, Hendry JH, Roberts SA, Slevin NJ, Duncan WB, MacDougall RH, Kerr GR, O'Sullivan B, Keane TJ. Similar decreases in local tumor control are calculated for treatment protraction and for interruptions in the radiotherapy of carcinoma of the larynx in four centers. Int J Radiat Oncol Biol Phys. 1998 Jan 15;40(2):319-29. doi: 10.1016/s0360-3016(97)00716-5.

    PubMed 9457816

  • Groome PA, O'Sullivan B, Mackillop WJ, Jackson LD, Schulze K, Irish JC, Warde PR, Schneider KM, Mackenzie RG, Hodson DI, Hammond JA, Gulavita SP, Eapen LJ, Dixon PF, Bissett RJ. Compromised local control due to treatment interruptions and late treatment breaks in early glottic cancer: Population-based outcomes study supporting need for intensified treatment schedules. Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):1002-12. doi: 10.1016/j.ijrobp.2005.10.010. Epub 2006 Jan 18.

    PubMed 16414205

  • Herrmann T, Jakubek A, Trott KR. The importance of the timing of a gap in radiotherapy of squamous cell carcinomas of the head and neck. Strahlenther Onkol. 1994 Sep;170(9):545-9.

    PubMed 7940126

  • Thomas K, Martin T, Gao A, Ahn C, Wilhelm H, Schwartz DL. Interruptions of Head and Neck Radiotherapy Across Insured and Indigent Patient Populations. J Oncol Pract. 2017 Apr;13(4):e319-e328. doi: 10.1200/JOP.2016.017863. Epub 2017 Mar 7.

    PubMed 28267393

  • Suwinski R, Sowa A, Rutkowski T, Wydmanski J, Tarnawski R, Maciejewski B. Time factor in postoperative radiotherapy: a multivariate locoregional control analysis in 868 patients. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):399-412. doi: 10.1016/s0360-3016(02)04469-3.

    PubMed 12738315

  • Tang HT, Ou SC, Chu CL, Lee AL, Lin HJ, Lin YC, Wang YC, Yang SN, Lien MY. Chinese Herbal Medicine for Concurrent Chemoradiation-Induced Adverse Events in Head and Neck Cancer Patients: A Prospective Feasibility Study. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251326946. doi: 10.1177/15347354251326946. Epub 2025 Mar 24.

    PubMed 40123292

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SZKJT(San-Zhong-Kui-Jian-Tang) in people with Head and Neck Neoplasm and Chemoradiotherapy, run by China Medical University Hospital 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 26 Oct 2022. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The completion rate (time frame: We will do an assessment at the seventh week of CCRT. Patients who had completed a seven-week course of treatment and had a cumulative dose of cisplatin greater than 200 mg per m2 will be considered the completion group.). 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 NCT05590650, which also lists 15 linked publications.

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 26 Oct 2022; AzTrials last refreshed its copy on 3 Nov 2026.

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