Evaluating Chinese Medicine Oral Rinse for Irradiated Oral Mucositis in Head & Neck Cancer Patients

NCT05664906 | Unknown Phase 1 DMC

• 1 other identifier: CM Rinse_OMRT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 60% and 90% of patients with head and neck (H\&N) cancers receiving standard radiotherapy (RT) and chemoradiotherapy (chemo-RT) will develop oral mucositis respectively. Oral mucositis (OM) is one of the dose-limiting adverse events which can also lead to emotional and nutritional problems. Clinically, it is usually observed by the end of first week of RT (after 10 Gy) and reaches peak damage in 14-21 days or by the end of treatment. Healing then takes approximately 2 to 3 weeks after completion of RT. For the Chinese Medicine (CM) interventions, many studies have been reviewed on the efficacy of mouthwash or internal herbal decoction to OM. Although some positive results were observed, most of them were performed by applying different assessment tools and lack of quality of life (QOL) or self-reported symptoms assessment. In addition, the intervention time and follow-up period were usually insufficient (stopped at the end of RT), therefore they could not review the long-term efficacy of CM according to normal progression of OM and the safety of using CM. Therefore, we hope this pilot study can evaluate the efficacy and safety of CM in a strict protocol.

Conditions

Head and Neck Neoplasms; Oral Mucositis (Ulcerative) Due to Radiation; Chinese Medicine Oral Rinse

Outcome Measures

Primary Outcomes (1)

• Comparison of the proportion of the most severe modified WHO Mucositis Grades

  * Comparison of the proportion of the most severe modified WHO Mucositis Grades among intervention and control groups during RT. * Grades of the OM will be assessed by a Registered Chinese medicine practitioner (CMP) at baseline and day 7 (±1d) of every week during the RT, the most severe grades during the treatment will be regarded for data analysis. * Modified WHO Mucositis Grading Scale: Grade 0 (none) - normal; Grade 1 (mild) - soreness/erythema; Grade 2 (moderate) - erythema, ulcer/pseudo-membranes, can eat solids (erythema with ulcers less than 1 cm); Grade 3 (severe) - ulcer/pseudo-membrane, (erythema with ulcers more than 1cm) requires liquid diet only; Grade 4 (life-threatening) - ulcer with hemorrhage and necrosis, alimentation not possible; cancer treatment that results in or contribute to death is reported separately.

  From baseline to week 12 after the end of RT during post intervention period

Secondary Outcomes (6)

• 10cm visual analogue scale (VAS) of oral pain

  Day 3 and day 7 (±1d) of every week during intervention period, end of week 4, week 8 and week 12 after the end of RT during post intervention period.

• Oral Mucositis Daily Questionnaire (OMDQ) (validated Chinese version with modification)

  Day 3 and day 7 (±1d) of every week during intervention period, once a week during post intervention period, end of week 4, week 8 and week 12 after the end of RT during post intervention period.

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (Head and Neck) (EORTC QLQ-C30) (Hong Kong Cantonese version)

  Day 7 (±1d) of every week during intervention period, end of week 4, week 8 and week 12 after the end of RT during post intervention period.

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (Head and Neck) (EORTC QLQ-H&N35) (Hong Kong Cantonese version)

  Day 7 (±1d) of every week during intervention period, end of week 4, week 8 and week 12 after the end of RT during post intervention period.

• Body mass index (BMI)

  From baseline to week 12 after the end of RT during post intervention period

Study Arms (2)

Intervention Group: Chinese Medicine Oral Rinse and Standard Care

ACTIVE COMPARATOR

* Prescription and oral rinsing with Chinese Medicine Oral Rinse Formula-I (CMORF-I) which mainly consists of the Nong's concentrated CM granules of Wu Wei Xiao Du Yin and other ingredients. * Standard care will be following the indications provided by patient's western medical doctor. * Patients should not take any other TCM and non-prescribed medication and nutritional supplements during the intervention period.

Drug: Chinese Medicine Oral Rinse Formula-I (CMORF-I); Other: Standard Care

Control Group: Placebo and Standard Care

PLACEBO COMPARATOR

* Placebo: The placebo consists of an inert substance, made of starch filler, flavor and colorings. It is also manufactured under GMP standard. To ensure blinding, the CMORF-I formula and placebo will be indistinguishable in appearance, smell and favour. * Standard care will be following the indications provided by patient's western medical doctor. * Patients should not take any other TCM and non-prescribed medication and nutritional supplements during the intervention period.

Other: Standard Care; Other: Placebo

Interventions

Chinese Medicine Oral Rinse Formula-I (CMORF-I) DRUG

* Prescription of Chinese Medicine Oral Rinse Formula-I (CMORF-I) * Instruction to rinse: 1. The above amount of concentrated CM granules will be divided and packed in 4 bags per day. 2. Dissolve 1 bag of concentrated CM granules with 150ml 80'C boiled hot water, and wait for 20 mins to cool down. 3. Clean the mouth thoughtfully by rinsing with 150ml of distilled water for 2 minutes. 4. Rinse the mouth thoughtfully with one-third of the dissolved and cooled CM oral rinse, gargle, expel after 3 minutes, do not swallow and repeat twice. 5. To ensure better contact of the CM oral rinse in all parts and folds of the oral cavity, our research assistant and CMP will guide the patients to fully agitate the mouth, use the tongue to stir repeatedly among the teeth, cheeks and palate surface, and to raise the tip of the tongue for a moment and tilt the head back. 6. 4 times a day (half an hour after every meal, half an hour before sleep), from baseline to 2 weeks after RT.

Also known as: CMORF-I

Intervention Group: Chinese Medicine Oral Rinse and Standard Care

Standard Care OTHER

• Standard care including normal saline or medical mouthwash, optional analgesics and antibiotics will be offered by hospital.

Control Group: Placebo and Standard Care; Intervention Group: Chinese Medicine Oral Rinse and Standard Care

Placebo OTHER

Placebo granules, instruction is the same as CMORF-I.

Control Group: Placebo and Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are aged ≥18, with known diagnosis of non-metastatic hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, and salivary gland cancer.
• are the first time to receive RT to the primary tumor in the area of the head or face, neck, or oral cavity.
• start RT recently within 14 days.
• are assessed by CMPs for the condition of oral mucositis according to modified World Health Organization (WHO) Mucositis Grades with Grade ≦1.
• have Karnofsky Performance Status (KPS) ≥ 60 (patients require occasional assistance, but is able to care for most personal needs will be 60 or above).
• are able to read or understand and sign the consent form.

You may not qualify if:

• receive concurrent chemo-radiation.
• have known medication on bacterial or fungal infections of oropharynx at recruitment.
• have other known diseases such as serious and uncontrolled Diabetes mellitus (with symptom of delayed wound healing over the past half year) or hyperthyroidism (with symptom of serious oral dryness over the past half year), known connective vascular disorders or known Human Immunodeficiency Virus (HIV) infections etc.
• have known history of allergy to CMORF-I ingredients or Glucose-6-Phosphate Dehydrogenase (G6PD) patients.
• are known pregnant or breastfeeding.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Hong Kong Institute of Integrative Medicine

Hong Kong, Hong Kong

Location

Related Publications (53)

• World Health Organization. WHO Handbook for Reporting the Results of Cancer Treatment. Geneva: WHO Offset Publications, 1979; 48:15-22

  BACKGROUND

• National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE 4.03) from: https://ctep.cancer.gov/protocolDevelopment/adverse_effects.htm

  BACKGROUND

• Chinese Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China (English Edition) Vol. 1. Beijing, China: China Medical Science Press; 2015.

  BACKGROUND

• Sutherland SE, Browman GP. Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients: a proposed classification scheme of interventions and meta-analysis of randomized controlled trials. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):917-30. doi: 10.1016/s0360-3016(00)01456-5.

  PMID: 11240232 RESULT

• Lichtman SM. Physiological aspects of aging. Implications for the treatment of cancer. Drugs Aging. 1995 Sep;7(3):212-25. doi: 10.2165/00002512-199507030-00006.

  PMID: 8535051 RESULT

• Ps SK, Balan A, Sankar A, Bose T. Radiation induced oral mucositis. Indian J Palliat Care. 2009 Jul;15(2):95-102. doi: 10.4103/0973-1075.58452.

  PMID: 20668585 RESULT

• Luo DH, Hong MH, Guo L, Cao KJ, Deng MQ, Mo HY. [Analysis of oral mucositis risk factors during radiotherapy for nasopharyngeal carcinoma patients and establishment of a discriminant model]. Ai Zheng. 2005 Jul;24(7):850-4. Chinese.

  PMID: 16004814 RESULT

• Saito N, Imai Y, Muto T, Sairenchi T. Low body mass index as a risk factor of moderate to severe oral mucositis in oral cancer patients with radiotherapy. Support Care Cancer. 2012 Dec;20(12):3373-7. doi: 10.1007/s00520-012-1620-7. Epub 2012 Oct 7.

  PMID: 23052923 RESULT

• Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.

  PMID: 32786044 RESULT

• Rashad UM, Al-Gezawy SM, El-Gezawy E, Azzaz AN. Honey as topical prophylaxis against radiochemotherapy-induced mucositis in head and neck cancer. J Laryngol Otol. 2009 Feb;123(2):223-8. doi: 10.1017/S0022215108002478. Epub 2008 May 19.

  PMID: 18485252 RESULT

• Yarom N, Hovan A, Bossi P, Ariyawardana A, Jensen SB, Gobbo M, Saca-Hazboun H, Kandwal A, Majorana A, Ottaviani G, Pentenero M, Nasr NM, Rouleau T, Lucas AS, Treister NS, Zur E, Ranna V, Vaddi A, Barasch A, Lalla RV, Cheng KKF, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer / International Society of Oral Oncology (MASCC/ISOO). Systematic review of natural and miscellaneous agents, for the management of oral mucositis in cancer patients and clinical practice guidelines - part 2: honey, herbal compounds, saliva stimulants, probiotics, and miscellaneous agents. Support Care Cancer. 2020 May;28(5):2457-2472. doi: 10.1007/s00520-019-05256-4. Epub 2020 Feb 13.

  PMID: 32056010 RESULT

• Elting LS, Keefe DM, Sonis ST, Garden AS, Spijkervet FK, Barasch A, Tishler RB, Canty TP, Kudrimoti MK, Vera-Llonch M; Burden of Illness Head and Neck Writing Committee. Patient-reported measurements of oral mucositis in head and neck cancer patients treated with radiotherapy with or without chemotherapy: demonstration of increased frequency, severity, resistance to palliation, and impact on quality of life. Cancer. 2008 Nov 15;113(10):2704-13. doi: 10.1002/cncr.23898.

  PMID: 18973181 RESULT

• Stiff PJ, Erder H, Bensinger WI, Emmanouilides C, Gentile T, Isitt J, Lu ZJ, Spielberger R. Reliability and validity of a patient self-administered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT). Bone Marrow Transplant. 2006 Feb;37(4):393-401. doi: 10.1038/sj.bmt.1705250.

  PMID: 16415901 RESULT

• GU, Y., GONG, L., & Yan, H. (2014). Reliability and validity of Chinese version of Oral Mucositis Daily Questionnaire (OMDQ). Chinese Journal of Nursing, 49(1), 108-112.

  RESULT

• Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.

  PMID: 15108222 RESULT

• Stokman MA, Burlage FR, Spijkervet FK. The effect of a calcium phosphate mouth rinse on (chemo) radiation induced oral mucositis in head and neck cancer patients: a prospective study. Int J Dent Hyg. 2012 Aug;10(3):175-80. doi: 10.1111/j.1601-5037.2012.00574.x.

  PMID: 23046006 RESULT

• Roopashri G, Jayanthi K, Guruprasad R. Efficacy of benzydamine hydrochloride, chlorhexidine, and povidone iodine in the treatment of oral mucositis among patients undergoing radiotherapy in head and neck malignancies: A drug trail. Contemp Clin Dent. 2011 Jan;2(1):8-12. doi: 10.4103/0976-237X.79292.

  PMID: 22114446 RESULT

• Shang X, Pan H, Li M, Miao X, Ding H. Lonicera japonica Thunb.: ethnopharmacology, phytochemistry and pharmacology of an important traditional Chinese medicine. J Ethnopharmacol. 2011 Oct 31;138(1):1-21. doi: 10.1016/j.jep.2011.08.016. Epub 2011 Aug 16.

  PMID: 21864666 RESULT

• Li Y, Li W, Fu C, Song Y, Fu Q. Lonicerae japonicae flos and Lonicerae flos: a systematic review of ethnopharmacology, phytochemistry and pharmacology. Phytochem Rev. 2020;19(1):1-61. doi: 10.1007/s11101-019-09655-7. Epub 2019 Nov 22.

  PMID: 32206048 RESULT

• Li Y, Cai W, Weng X, Li Q, Wang Y, Chen Y, Zhang W, Yang Q, Guo Y, Zhu X, Wang H. Lonicerae Japonicae Flos and Lonicerae Flos: A Systematic Pharmacology Review. Evid Based Complement Alternat Med. 2015;2015:905063. doi: 10.1155/2015/905063. Epub 2015 Jul 16.

  PMID: 26257818 RESULT

• Sun S, Jiang P, Su W, Xiang Y, Li J, Zeng L, Yang S. Wild chrysanthemum extract prevents UVB radiation-induced acute cell death and photoaging. Cytotechnology. 2016 Mar;68(2):229-40. doi: 10.1007/s10616-014-9773-5. Epub 2014 Jul 23.

  PMID: 25052044 RESULT

• Luyen BT, Tai BH, Thao NP, Cha JY, Lee HY, Lee YM, Kim YH. Anti-inflammatory components of Chrysanthemum indicum flowers. Bioorg Med Chem Lett. 2015 Jan 15;25(2):266-9. doi: 10.1016/j.bmcl.2014.11.054. Epub 2014 Nov 27.

  PMID: 25497988 RESULT

• Shao Y, Sun Y, Li D, Chen Y. Chrysanthemum indicum L.: A Comprehensive Review of its Botany, Phytochemistry and Pharmacology. Am J Chin Med. 2020;48(4):871-897. doi: 10.1142/S0192415X20500421. Epub 2020 May 20.

  PMID: 32431180 RESULT

• Hwang ES, Kim GH. Safety Evaluation of Chrysanthemum indicum L. Flower Oil by Assessing Acute Oral Toxicity, Micronucleus Abnormalities, and Mutagenicity. Prev Nutr Food Sci. 2013 Jun;18(2):111-6. doi: 10.3746/pnf.2013.18.2.111.

  PMID: 24471119 RESULT

• Schutz K, Carle R, Schieber A. Taraxacum--a review on its phytochemical and pharmacological profile. J Ethnopharmacol. 2006 Oct 11;107(3):313-23. doi: 10.1016/j.jep.2006.07.021. Epub 2006 Jul 22.

  PMID: 16950583 RESULT

• Martinez M, Poirrier P, Chamy R, Prufer D, Schulze-Gronover C, Jorquera L, Ruiz G. Taraxacum officinale and related species-An ethnopharmacological review and its potential as a commercial medicinal plant. J Ethnopharmacol. 2015 Jul 1;169:244-62. doi: 10.1016/j.jep.2015.03.067. Epub 2015 Apr 6.

  PMID: 25858507 RESULT

• Du D, Cheng Z, Chen D. Anti-complement sesquiterpenes from Viola yedoensis. Fitoterapia. 2015 Mar;101:73-9. doi: 10.1016/j.fitote.2014.12.015. Epub 2015 Jan 3.

  PMID: 25562805 RESULT

• Xie C, Kokubun T, Houghton PJ, Simmonds MS. Antibacterial activity of the Chinese traditional medicine, Zi Hua Di Ding. Phytother Res. 2004 Jun;18(6):497-500. doi: 10.1002/ptr.1497.

  PMID: 15287078 RESULT

• Jeong YH, Oh YC, Cho WK, Shin H, Lee KY, Ma JY. Anti-inflammatory effects of Viola yedoensis and the application of cell extraction methods for investigating bioactive constituents in macrophages. BMC Complement Altern Med. 2016 Jun 14;16:180. doi: 10.1186/s12906-016-1142-9.

  PMID: 27301877 RESULT

• Su Y, Zhang Z, Guo C. A new nitroethylphenolic glycoside from Semiaquilegia adoxoides. Fitoterapia. 2004 Jun;75(3-4):420-2. doi: 10.1016/j.fitote.2004.01.016.

  PMID: 15159012 RESULT

• Yang Y, Guo L, Tariq K, Zhang W, Li C, Memon FQ, Chai B, Li Z, Sun J, Chen Y, Zhang G, Li Q, Wang S, Wang L, Lai C, Jiang M, Si H. The Antioxidant Polysaccharide from Semiaquilegia adoxoides (DC.) Makino Adjusts the Immune Response of Mice Infected by Bacteria. Evid Based Complement Alternat Med. 2020 Feb 19;2020:2719483. doi: 10.1155/2020/2719483. eCollection 2020.

  PMID: 32148535 RESULT

• Duan SP, Jin CL, Hao J, Hou LJ, Li AH, Zhu ZP, Gao JH, Pan Y. A study on the inhibitory effect of Radix Semiaquilegiae extract on human hepatoma HEPG-2 and SMMC-7721 cells. Afr J Tradit Complement Altern Med. 2013 Aug 12;10(5):336-40. doi: 10.4314/ajtcam.v10i5.19. eCollection 2013.

  PMID: 24311846 RESULT

• Jiang F, Li W, Huang Y, Chen Y, Jin B, Chen N, Ding Z, Ding X. Antioxidant, antityrosinase and antitumor activity comparison: the potential utilization of fibrous root part of Bletilla striata (Thunb.) Reichb.f. PLoS One. 2013;8(2):e58004. doi: 10.1371/journal.pone.0058004. Epub 2013 Feb 28.

  PMID: 23469127 RESULT

• He X, Wang X, Fang J, Zhao Z, Huang L, Guo H, Zheng X. Bletilla striata: Medicinal uses, phytochemistry and pharmacological activities. J Ethnopharmacol. 2017 Jan 4;195:20-38. doi: 10.1016/j.jep.2016.11.026. Epub 2016 Nov 16.

  PMID: 27865796 RESULT

• Xu D, Pan Y, Chen J. Chemical Constituents, Pharmacologic Properties, and Clinical Applications of Bletilla striata. Front Pharmacol. 2019 Nov 1;10:1168. doi: 10.3389/fphar.2019.01168. eCollection 2019.

  PMID: 31736742 RESULT

• Zhang RX, Li MX, Jia ZP. Rehmannia glutinosa: review of botany, chemistry and pharmacology. J Ethnopharmacol. 2008 May 8;117(2):199-214. doi: 10.1016/j.jep.2008.02.018. Epub 2008 Mar 10.

  PMID: 18407446 RESULT

• Lim DW, Kim YT. Dried root of Rehmannia glutinosa prevents bone loss in ovariectomized rats. Molecules. 2013 May 17;18(5):5804-13. doi: 10.3390/molecules18055804.

  PMID: 23685937 RESULT

• Feng JC, Cai ZL, Zhang XP, Chen YY, Chang XL, Wang XF, Qin CB, Yan X, Ma X, Zhang JX, Nie GX. The Effects of Oral Rehmannia glutinosa Polysaccharide Administration on Immune Responses, Antioxidant Activity and Resistance Against Aeromonas hydrophila in the Common Carp, Cyprinus carpio L. Front Immunol. 2020 May 8;11:904. doi: 10.3389/fimmu.2020.00904. eCollection 2020.

  PMID: 32457762 RESULT

• Li HW, Liu P, Zhang HQ, Feng WM, Yan H, Guo S, Qian DW, Duan JA. Determination of bioactive compounds in the nonmedicinal parts of Scrophularia ningpoensis using ultra-high-performance liquid chromatography coupled with tandem mass spectrometry and chemometric analysis. J Sep Sci. 2020 Nov;43(22):4191-4201. doi: 10.1002/jssc.202000723. Epub 2020 Oct 12.

  PMID: 32975375 RESULT

• Ren D, Shen ZY, Qin LP, Zhu B. Pharmacology, phytochemistry, and traditional uses of Scrophularia ningpoensis Hemsl. J Ethnopharmacol. 2021 Apr 6;269:113688. doi: 10.1016/j.jep.2020.113688. Epub 2020 Dec 16.

  PMID: 33338592 RESULT

• Wang J, Huang L, Ren Q, Wang Y, Zhou L, Fu Y, Sai C, Pella SS, Guo Y, Gao LN. Polysaccharides of Scrophularia ningpoensis Hemsl.: Extraction, Antioxidant, and Anti-Inflammatory Evaluation. Evid Based Complement Alternat Med. 2020 Dec 15;2020:8899762. doi: 10.1155/2020/8899762. eCollection 2020.

  PMID: 33381217 RESULT

• Wang Z, He C, Peng Y, Chen F, Xiao P. Origins, Phytochemistry, Pharmacology, Analytical Methods and Safety of Cortex Moutan (Paeonia suffruticosa Andrew): A Systematic Review. Molecules. 2017 Jun 7;22(6):946. doi: 10.3390/molecules22060946.

  PMID: 28590441 RESULT

• Zhang L, Li DC, Liu LF. Paeonol: pharmacological effects and mechanisms of action. Int Immunopharmacol. 2019 Jul;72:413-421. doi: 10.1016/j.intimp.2019.04.033. Epub 2019 Apr 25.

  PMID: 31030097 RESULT

• Li P, Shen J, Wang Z, Liu S, Liu Q, Li Y, He C, Xiao P. Genus Paeonia: A comprehensive review on traditional uses, phytochemistry, pharmacological activities, clinical application, and toxicology. J Ethnopharmacol. 2021 Apr 6;269:113708. doi: 10.1016/j.jep.2020.113708. Epub 2020 Dec 24.

  PMID: 33346027 RESULT

• Stasiak N, Kukula-Koch W, Glowniak K. Modern industrial and pharmacological applications of indigo dye and its derivatives--a review. Acta Pol Pharm. 2014 Mar-Apr;71(2):215-21.

  PMID: 25272640 RESULT

• Qi-Yue Y, Ting Z, Ya-Nan H, Sheng-Jie H, Xuan D, Li H, Chun-Guang X. From natural dye to herbal medicine: a systematic review of chemical constituents, pharmacological effects and clinical applications of indigo naturalis. Chin Med. 2020 Dec 14;15(1):127. doi: 10.1186/s13020-020-00406-x.

  PMID: 33317592 RESULT

• Gu S, Xue Y, Gao Y, Shen S, Zhang Y, Chen K, Xue S, Pan J, Tang Y, Zhu H, Wu H, Dou D. Mechanisms of indigo naturalis on treating ulcerative colitis explored by GEO gene chips combined with network pharmacology and molecular docking. Sci Rep. 2020 Sep 16;10(1):15204. doi: 10.1038/s41598-020-71030-w.

  PMID: 32938944 RESULT

• El-Saber Batiha G, Magdy Beshbishy A, El-Mleeh A, Abdel-Daim MM, Prasad Devkota H. Traditional Uses, Bioactive Chemical Constituents, and Pharmacological and Toxicological Activities of Glycyrrhiza glabra L. (Fabaceae). Biomolecules. 2020 Feb 25;10(3):352. doi: 10.3390/biom10030352.

  PMID: 32106571 RESULT

• Pastorino G, Cornara L, Soares S, Rodrigues F, Oliveira MBPP. Liquorice (Glycyrrhiza glabra): A phytochemical and pharmacological review. Phytother Res. 2018 Dec;32(12):2323-2339. doi: 10.1002/ptr.6178. Epub 2018 Aug 17.

  PMID: 30117204 RESULT

• Isbrucker RA, Burdock GA. Risk and safety assessment on the consumption of Licorice root (Glycyrrhiza sp.), its extract and powder as a food ingredient, with emphasis on the pharmacology and toxicology of glycyrrhizin. Regul Toxicol Pharmacol. 2006 Dec;46(3):167-92. doi: 10.1016/j.yrtph.2006.06.002. Epub 2006 Aug 1.

  PMID: 16884839 RESULT

• Mangal P, Khare P, Jagtap S, Bishnoi M, Kondepudi KK, Bhutani KK. Screening of six Ayurvedic medicinal plants for anti-obesity potential: An investigation on bioactive constituents from Oroxylum indicum (L.) Kurz bark. J Ethnopharmacol. 2017 Feb 2;197:138-146. doi: 10.1016/j.jep.2016.07.070. Epub 2016 Jul 26.

  PMID: 27469197 RESULT

• Harminder, Singh V, Chaudhary AK. A Review on the Taxonomy, Ethnobotany, Chemistry and Pharmacology of Oroxylum indicum Vent. Indian J Pharm Sci. 2011 Sep;73(5):483-90. doi: 10.4103/0250-474X.98981.

  PMID: 22923859 RESULT

• Chen J, Chen J, Lu J. Systematic Elucidation of the Mechanism of Oroxylum indicum via Network Pharmacology. Evid Based Complement Alternat Med. 2020 Jul 14;2020:5354215. doi: 10.1155/2020/5354215. eCollection 2020.

  PMID: 32733583 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis; Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• KWOK YIN AU, Doctor of Medicine

  Hong Kong Institute of Integrative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KWOK YIN AU, Doctor of Medicine

CONTACT

+852 28733100; davidau@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. AU Kwok Yin

Model Details: A randomized controlled pilot study will be employed, participants will receive either CM Oral Rinse granules (CMORF-I) or placebo while they will receive standard care too. Since the duration of RT and recruitment time may vary, the intervention period starts from baseline (14 days within RT starts) to 2 weeks after the end of RT, while the post-intervention period will be 10 weeks starting from 2 weeks after the end of RT with 3 post-intervention follow-up visits (4 weeks, 8 weeks and 12 weeks after the end of RT).

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: December 27, 2022
• Study Start: January 31, 2023
• Primary Completion: May 31, 2024
• Study Completion: November 30, 2024
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)