The Effectiveness of a Thyme and Honey Spray for Oral Toxicities

NCT04880148 | Unknown DMC

• 1 other identifier: 21-HONEY-CUT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Aim: To evaluate the effectiveness of thymus honey on radiation induced-oral mucositis and xerostomia. Background: Oral mucositis and xerostomia are two of the most severe side effects that head and neck cancer patients confront during and after the completion of radiotherapy. Although several medications are used for their treatment, these fail to provide a fully effective and comprehensive management. Honey and thyme have been studied for the management of various treatment-related side effects. Design: Α double blinded randomised controlled trial will be used for this study. Methods: 200 head and neck cancer patients who receive radiotherapy will be included in this study. Patients will be randomised and divided into two equal groups of 100 participants; the intervention group (oral spray with thyme and honey + standard care) and the control group ( placebo spray + standard care). Assessments with xerostomia and oral mucositis scales additionally to 4 self-administered questionnaires will occur in both groups at baseline and then weekly and 6 months following completion of treatment. The duration of the study will be 3 years from the day of approval of this research protocol.

Conditions

Cancer of the Head and Neck; Xerostomia; Oral Mucositis; Radiation Toxicity

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Mucositis Grade (RTOG) at weekly assessments

  The scale includes 5 grades (from 0 to IV). Higher grade denotes more severe mucositis

  Baseline (week 4), week 5, week 6, week 7, week 8 and week 24

• Change from baseline in Xerostomia Grade (CTCAE) at weekly assessments

  he scale includes 5 grades (from 0 to IV). Higher grade denotes more severe xerostomia

  Baseline (week 4), week 5, week 6, week 7, week 8 and week 24

Secondary Outcomes (4)

• Change from baseline in Xerostomia Questionnaire (Dirix et al)

  Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy

• Change from baseline in Oral Mucositis Questionnaire (OMWQ)

  Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy

• Change from baseline in health-related QoL (EORTC QLQ-C30) questionnaire

  Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy

• Change from baseline in health-related QoL (EORTC QLQ-H&N43) questionnaire

  Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy

Study Arms (2)

Thyme and Honey-based oral spray

EXPERIMENTAL

Thyme and Honey-based oral spray

Dietary Supplement: Thyme and Honey-based oral spray

Placebo oral spray

PLACEBO COMPARATOR

Placebo oral spray

Dietary Supplement: Placebo oral spray

Interventions

Thyme and Honey-based oral spray DIETARY_SUPPLEMENT

4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session

Thyme and Honey-based oral spray

Placebo oral spray DIETARY_SUPPLEMENT

4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session

Placebo oral spray

Eligibility Criteria

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

You may qualify if:

• Patients with a confirmed histologic diagnosis of head and neck cancer
• Patients referred to non-palliative radiotherapy to the oral cavity will be included in the study
• Synchronous or induction chemotherapy, or both, will be permitted.
• Patients aged over 18,
• Patients able to provide informed consent,
• Patients having radiotherapy for at least three weeks (lower limit has been set at 50 Gy),
• Patients able to complete records accurately

You may not qualify if:

• Patients with a confirmed and medically treated diabetes mellitus,
• Patients with allergy to honey, thyme or any other ingredient,
• Patients who will refuse to take part in this study and
• Patients with previous radiotherapy or presence of systemic disease.

Sponsors & Collaborators

• Cyprus University of Technology: lead
• German Oncology Center, Cyprus: collaborator
• Bank of Cyprus Oncology Center BOCOC: collaborator

Study Sites (2)

German Oncology Center

Limassol, 4108, Cyprus

RECRUITING

Bank of Cyprus Oncology Center

Nicosia, 2006, Cyprus

NOT YET RECRUITING

Related Publications (4)

• Thrasyvoulou S, Tsitsi T, Katodritis N, Vomvas D, Charalambous M, Charalambous A. Reliability and Validity of the Greek Version of the Oral Mucositis Weekly Questionnaire in the Head and Neck Cancer Context. J Nurs Meas. 2021 Aug 1;29(2):317-333. doi: 10.1891/JNM-D-19-00096. Epub 2021 Mar 19.

  PMID: 33741726 BACKGROUND

• Charalambous A. Hermeneutic phenomenological interpretations of patients with head and neck neoplasm experiences living with radiation-induced xerostomia: the price to pay? Eur J Oncol Nurs. 2014 Oct;18(5):512-20. doi: 10.1016/j.ejon.2014.04.007. Epub 2014 May 27.

  PMID: 24877858 BACKGROUND

• Charalambous M, Raftopoulos V, Paikousis L, Katodritis N, Lambrinou E, Vomvas D, Georgiou M, Charalambous A. The effect of the use of thyme honey in minimizing radiation - induced oral mucositis in head and neck cancer patients: A randomized controlled trial. Eur J Oncol Nurs. 2018 Jun;34:89-97. doi: 10.1016/j.ejon.2018.04.003. Epub 2018 Apr 30.

  PMID: 29784145 RESULT

• Charalambous A, Lambrinou E, Katodritis N, Vomvas D, Raftopoulos V, Georgiou M, Paikousis L, Charalambous M. The effectiveness of thyme honey for the management of treatment-induced xerostomia in head and neck cancer patients: A feasibility randomized control trial. Eur J Oncol Nurs. 2017 Apr;27:1-8. doi: 10.1016/j.ejon.2017.01.001. Epub 2017 Jan 16.

  PMID: 28279391 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Xerostomia; Stomatitis; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Wounds and Injuries

Study Officials

• Andreas Charalambous, PhD

  Cyprus University of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Charalambous, PhD

CONTACT

25002011; andreas.charalambous@cut.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: November 3, 2021
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CY (2)