ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 119 for:    dry mouth | Recruiting Studies

Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03035825
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
Mahidol University
Srinakharinwirot University
Ministry of Health, Thailand
Information provided by (Responsible Party):
Dental Innovation Foundation Under Royal Patronage

Brief Summary:
This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.

Condition or disease Intervention/treatment Phase
Cancer of Head Neck Radiation-Induced Xerostomia Dry Mouth Dietary Supplement: Oral moisturizing jelly Other: Artificial saliva Not Applicable

Detailed Description:
Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This randomized control trial intends to determine if continuous use of oral moisturizing jelly may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy intake and reduce umami taste recognition threshold.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial for Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients With Xerostomia
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral Moisturizing Jelly
Daily intake of oral moisturizing jelly 5 times/day for two months
Dietary Supplement: Oral moisturizing jelly
Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth

Active Comparator: Artificial saliva
Daily use of non-edible oral lubricating gel 5 times/day for two months
Other: Artificial saliva
A non-edible oral lubricating gel for dry mouth patients
Other Name: Dry mouth gel




Primary Outcome Measures :
  1. Changes in subjective dry mouth score compared to baseline [ Time Frame: Baseline, 1 and 2 months after intervention ]
    Evaluation of subjective dry mouth score by questionaire


Secondary Outcome Measures :
  1. Changes in objective dry mouth score compared to baseline [ Time Frame: Baseline, 1 and 2 months after intervention ]
    Evaluation of objective dry mouth score by oral examination

  2. Changes in salivary pH compared to baseline [ Time Frame: Baseline, 1 and 2 months after intervention ]
    Evaluation of salivary pH using pH indicator paper

  3. Changes in salivary buffering capacity compared to baseline [ Time Frame: Baseline, 1 and 2 months after intervention ]
    Evaluation of salivary buffering capacity using a commercial saliva check buffer kit

  4. Changes in Candidal counts of saliva compared to baseline [ Time Frame: Baseline, 1 and 2 months after intervention ]
    Evaluation of number of fungal colonies of Candida spp. in saliva by culture

  5. Changes in energy intake compared to baseline [ Time Frame: Baseline, 1 and 2 months after intervention ]
    Evaluation of energy intake per day using dietary record and analysis

  6. Changes in subjective swallow ability compared to baseline [ Time Frame: Baseline, 1 and 2 months after intervention ]
    Evaluation of subjective swallow ability using EAT-10 questionaire

  7. Changes in appetite compared to baseline [ Time Frame: Baseline, 1 and 2 months after intervention ]
    Evaluation of appetite using questionnaire

  8. Changes in tolerance to spicy food [ Time Frame: Baseline, 1 and 2 months after intervention ]
    Evaluation of tolerance to spicy food using questionnaire

  9. Changes in umami taste recognition threshold compared to baseline [ Time Frame: Baseline, 1 and 2 months after intervention ]
    Evaluation of umami taste recognition threshold using filter paper disc method



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month.
  2. If undergoing chemotherapy, have to finish for at least 2 weeks.
  3. Have subjective dry mouth scores at least 3
  4. Can perform oral intake without aspiration
  5. Can communicate well

Exclusion Criteria:

  1. Has recurrence of cancer
  2. Has mucositis more than grade 1
  3. Has oral infection such as candidiasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035825


Contacts
Contact: Aroonwan Lam-ubol, DDS, PhD 6681-9363145 aroonwanlam@gmail.com
Contact: Dunyaporn Trachootham, DDS, PhD dif.dunyaporn@gmail.com

Locations
Thailand
Chonburi Cancer Hospital Recruiting
Chonburi, Thailand, 20000
Contact: Onong Mungkung, DDS       o.mungkung@gmail.com   
Sponsors and Collaborators
Dental Innovation Foundation Under Royal Patronage
Mahidol University
Srinakharinwirot University
Ministry of Health, Thailand
Investigators
Principal Investigator: Aroonwan Lam-ubol, DDS, PhD Srinakarinwirot University

Responsible Party: Dental Innovation Foundation Under Royal Patronage
ClinicalTrials.gov Identifier: NCT03035825     History of Changes
Other Study ID Numbers: DIF-05
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases