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Head and Neck NeoplasmsPhase 1/2NCT05664906

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

A Phase 1/2 study testing Chinese Medicine Oral Rinse Formula-I (CMORF-I) in people with Head and Neck Neoplasms and Oral Mucositis (Ulcerative) Due to Radiation, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chinese Medicine Oral Rinse Formula-I (CMORF-I)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteHong Kong
Study dates
31 Jan 2023to 30 Nov 2024
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

KWOK YIN AU, Doctor of Medicine contact

+852 28733100

davidau@cuhk.edu.hk

Hong Kong1 site

  • Hong Kong Institute of Integrative Medicine

    Hong Kong

    KWOK YIN AU, PhD, +852 28733100, davidau@cuhk.edu.hk

Other trials in Hong Kong

About this study

Official title: Evaluating Efficacy and Safety of Chinese Medicine Oral Rinse in Treating and Preventing Irradiated Oral Mucositis in Head-and-Neck Cancer Patients - a Pilot Trial

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.

Read the detailed description

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.

The risk of OM is especially high in NPC patients who receive concomitant chemotherapy, receive a total dose over 5,000 Gy, treat with altered fractionation radiation schedules, have bad oral hygiene status, do not use antibiotic at early stage mucositis, have smoking history, drink alcohol, have problems in nutritional status like anorexia, malnutrition, lack of vitamins, restriction of food due to specific dietary requirements, have haematological disease or non-ideal hematological status, have advanced localization of tumors and stage, receive immunotherapy, have pre-existing dry mouth (Xerostomia), have episodes of OM during prior treatment cycles and low BMI, etc.

According to some weighed guidelines such as The Multinational Association of Supportive Care in Cancer and International Society for Oral Oncology (MASCC/ISOO) guidelines for the management of OM, recent systematic reviews and researches, there are mainly several sections for intervention: (1) Basic oral care, (2) Anti-inflammatory agents, (3) Photobiomodulation, (4) Cryotherapy, (5) Antimicrobials, coating agents, anesthetics, and analgesics, (6) Growth factors and cytokines, and (7) Natural and miscellaneous. We can summarize several suggestions for the prevention of OM in H\&N cancer adults receiving RT from the above protocols: multiagent combination oral care protocols (increasing the awareness of good oral hygiene), professional dental care (a desirable option before or during cancer therapy for local and systemic infections from odontogenic sources), benzydamine mouthwash (as the anti-inflammaotary agents for moderate dose of RT (<50 Gy)) and intraoral photobiomodulation therapy using low-level laser therapy. Over the years, the number of interventions studied for OM and their quality of study design have been dramatically increasing. However, since there are still some advantages and disadvantages for some suggested agents, some clinical settings have not yet been recommended with appropriate intervention. Natural and miscellaneous agents are also reviewed in the past years while honey is suggested for prevention of OM in patients with H\&N cancer who receive treatment with either RT or chemo-RT. However, if honey is applied repeatedly on a daily basis for a longer period, we have to be cautions with its deleterious effects. A strict oral hygiene protocol has to be followed to prevent dental caries.

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.

Being tested
Chinese Medicine Oral Rinse Formula-I (CMORF-I), Standard Care, Placebo
Medical subject headings
Head and Neck Neoplasms, Stomatitis, Ulcer

What participants receive

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

  • Chinese Medicine Oral Rinse Formula-I (CMORF-I)Drug

    Also called CMORF-I

    • 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.

  • Standard CareOther

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

  • PlaceboOther

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

Study groups in NCT05664906
Study groupRoleWhat they receive
Intervention Group: Chinese Medicine Oral Rinse and Standard CareActive 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.
Receives: Drug: Chinese Medicine Oral Rinse Formula-I (CMORF-I); Other: Standard Care
Control Group: Placebo and Standard CarePlacebo 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.
Receives: Other: Standard Care; Other: Placebo

What is being measured

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

  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.

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

Secondary outcomes (6)

  1. 10cm visual analogue scale (VAS) of oral pain

    It is a measurement of oral pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" on the left and "worst pain" on the right.

    Measured: 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.

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

    It is a measurement of self-reported quality of life. It contains 10 items, for most questions in the OMDQ, a higher score indicated a worsening in symptom severity or more interference with functional activity. For the question pertaining to overall health, a higher score indicates better overall health status.

    Measured: 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.

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

    It is a specific measurement of self-reported quality of life for Head and Neck cancer patients. It consists of 30 questions that indicate the extent to which you have experienced these symptoms or problems during the past week. Scoring from 1 "Not at all" to 4 "Very much".

    Measured: 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.

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

    It is a specific measurement of self-reported quality of life for Head and Neck cancer patients. It consists of 35 questions that indicate the extent to which you have experienced these symptoms or problems during the past week. Scoring from 1 "Not at all" to 4 "Very much".

    Measured: 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.

  5. Body mass index (BMI)

    It is a measurement of the amount of body fat based on height and weight that applies to adult men and women. It can assess and monitor the risk of OM to a certain extent.

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

  6. Number of analgesic and antibiotics use daily

    It can assess and monitor the conditions of OM.

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

Timeline

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

  1. First posted27 Dec 2022
  2. Study start31 Jan 2023 (estimated)
  3. Primary completion31 May 2024 (estimated)
  4. Study completion30 Nov 2024 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05664906
Sponsor's protocol ID
CM Rinse_OMRT
Status last verified
Dec 2022
First submitted
6 Nov 2022
Last updated
27 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

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

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

  • 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.

    PubMed 11240232

  • 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.

    PubMed 8535051

  • 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.

    PubMed 20668585

  • 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.

    PubMed 16004814

  • 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.

    PubMed 23052923

  • 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.

    PubMed 32786044

  • 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.

    PubMed 18485252

  • 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.

    PubMed 32056010

  • 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.

    PubMed 18973181

  • 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.

    PubMed 16415901

  • 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.

  • 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.

    PubMed 15108222

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Chinese Medicine Oral Rinse Formula-I (CMORF-I) in people with Head and Neck Neoplasms and Oral Mucositis (Ulcerative) Due to Radiation, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Dec 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 Hong Kong. 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 combined 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.

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?

Results are not available in the source record.

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

Contact KWOK YIN AU, Doctor of Medicine (+852 28733100, davidau@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the proportion of the most severe modified WHO Mucositis Grades (time frame: From baseline to week 12 after the end of RT during post intervention period). 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 NCT05664906, which also lists 53 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 27 Dec 2022.

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