Effects for Oral Mucositis Care During Chemoradiotherapy in Cancer Patients: Evaluation of the Bee Products

Taipei Medical University

Status: Not yet enrolling

Conditions: Oral Mucositis

Treatments: Other: propolis; Other: Usual care; Other: Honey product

Study type: Interventional

Funder types: Other

Identifiers

NCT05625841

N2021100301

Details and patient eligibility

About

Oral mucositis is common among cancer patients receiving radiotherapy and chemotherapy. 80-90% of the patients are suffering from the mucositis pain; poor nutrition and even treatment discontinued. Some self-paid medications like glutamine has been used to prevent mucositis before and during radiotherapy/chemotherapy. Randomized controlled trials have shown that honey and propolis may be used for the management of mucositis. Honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. This study plan to conduct an RCT comparing the effectiveness of honey, honey and green propolis, and usual care in mucositis of cancer patients.

Full description

Outcome Measures

1. Questionnaire collection: oral mucositis grade, pain scale, fatigue scale, dry mouth, nutritional status and quality of life scale.
2. Wearing the smart bracelet: The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status.
3. Saliva sample collection: Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva.
4. Stool and oral flora collection: Test stool and oral flora microbiota.

Enrollment: 135 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosed with a head and neck tumor.
2. receive chemotherapy or radiotherapy.
3. conscious clear and willing to participate in the research.
4. can communicate in Mandarin or Taiwanese.

Exclusion criteria

diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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135 participants in 3 patient groups, including a placebo group

Honey

Experimental group

Description:

Each pack of 10 grams of honey after three meals a day.

Treatment:

Other: Honey product

Honey and propolis

Experimental group

Description:

Each pack contains 0.7ml of propolis + 9.3g of honey after three meals a day.

Treatment:

Other: Honey product

Other: propolis

Usual care

Placebo Comparator group

Description:

General routine oral care.

Treatment:

Other: Usual care