Clinical effectiveness of a Supportive Oral Radiation Protection (SORP) management protocol in patients with head and neck cancer undergoing radiotherapy: A randomized controlled trial

Introduction

Head and neck cancer (HNC), an umbrella term for malignancies of larynx and hypopharynx, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, oral cavity, and salivary gland, accounts for about half a million cases annually, ranking it as the sixth most common cancer globally.1 Radiotherapy (RT) has a vital role in the treatment for head and neck cancer (HNC) either as a primary and only treatment modality or in conjunction with surgery and/or chemotherapy, sometimes as palliation to ease symptoms of advanced cancer such as pain, bleeding, dysphagia and to treat recurrent lesion.2 A conventional (RT) protocol involves a daily radiation fraction of 2 Gray (Gy) for 5 days per week and is continued for 6-7 weeks. Ionizing radiation causes damage to normal tissues located in the radiation portals.3 Thus, this therapy often complex and frequently associated with significant short-and long-term complications including mucositis, candidiasis, dysgeusia, dysphagia, weight loss, malnutrition, hypo-salivation, increased risk of dental caries, increased risk of progression of periodontal disease, dental hypersensitivity, infections, mucosal atrophy, trismus, neuropathic pain, osteoradionecrosis and a general feeling of malaise.4 Approximately all (90-97%) patients getting irradiation to the head and neck area develop a certain grade of mucositis. Although Radiation caries seems to be inevitable, the rate of caries can be minimized by following a stringent diet regime, regular follow-ups, oral hygiene maintenance along with professional oral prophylaxis at scheduled appointments.5 Osteoradionecrosis (ORN) of the jaw is defined as a non-healing exposure of the bone with necrosis, which starts with a breach in the oral mucosa and persists for at least 3 months in a patient who has undergone previous radiotherapy.6 Radiation produce an electronic backscatter, which may damage the surrounding soft tissue. To prevent post radiation complications, besides conventional care, in the clinical setting, home care shall also be included in the form of a spacer retainer. The polymerising acrylic resin being durable and adjustable shall be used to fabricate the spacers. 7

There is currently no consensus-based protocol for the oral management of patients undergoing radiotherapy with head and neck cancer. It has been shown that oral care alone does not sufficiently lower the incidence of severe oral mucositis in patients with head and neck cancer who are receiving radiotherapy, whereas a systematic and comprehensive oral care protocol may indirectly improve treatment compliance by decreasing the infection risk. Although oral care is essential for radiotherapy-induced oral mucositis, it cannot prevent severe oral mucositis by itself. Non-pharmacological interventions can provide positive effects on improving oral health in patients with HNC undergoing RT. However, no intervention combined with multicomponent oral care strategies has been designed to determine its effect on oral health for patients with HNC.

Aim of the study

To provide comprehensive dental treatment for oral cancer patients prior to radiation, during radiation and post radiation to evaluate their outcomes, outline a management strategy for these patients and emphasize the need for obtaining a dental clearance for all HNC patients undergoing RT.

Objectives of the study

-      To assess the oral health related quality of life in patients undergoing radiotherapy for Head and Neck Cancer (HNC)

-   To determine the effect of follow-up SORP management protocol designed to improve oral health in patients with HNC receiving radiotherapyand to develop and establish a protocol for patients with head and neck cancer undergoing radiotherapy.

-    To compare and evaluate the SORP management protocol and Conventional Care Program (CCP) on oral health in patients with head and neck cancer undergoing radiotherapy

Materials and Methods

Study design:

Double arm, parallel-group, Clinical trial

Study setting:

- Department of Radiation Oncology, Goa Medical College and Hospital

• Department of Public Health Dentistry, Goa Dental College & Hospital

Study tools:

*-*European Organization for Research and Treatment of Cancer Quality of Life Questionnaire              H&N35 (EORTC QLQ-H&N35)

• World Health Organization Oral Toxicity Scale (WHO Oral Toxicity Scale)

-The oral hygiene status will be recorded by WHO Dentition status;2013, OHI-S Index (Greene          and Jack R. Vermillion;1960), and gingival index (Loe H. and Silness J. 1963)

Sample size:

X1= 15.08, X2= 19.23

SD1= 5.24, SD2= 6.52

α-error at 5% = 1.96

power of test at 80% = 0.842

Effect size: 0.72

Final Sample Size: 25 (each group),

Total sample Size: 50

Sampling Technique

-       A simple random sampling technique. (Table of random numbers)

-  Allocation concealment using SNOSE (sequentially numbered, opaque, sealed envelope) technique

Procedure for measurements including process for standardization

**-**QoL will be evaluated using questionnaires prepared by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire H&N35 (EORTC QLQ-H&N35). The results of the QoL questionnaires will be analysed according to the specific scoring manual provided by the EORTC, all scores will be expressed on a scale ranging between 0 to 100.

• The EORTC QLQ-H&N35 questionnaire consists of 7 multi-item symptom scales (pain, sensory problems, social contact problems, swallowing, social eating problems, speech problems, and reduced sexuality) and 11 single-item symptom scales (nutritional supplement use, mouth opening problems, teeth problems, coughing, painkiller use, weight loss, weight gain, sticky saliva, feeding tube, dry mouth, and feeling ill). Most items were rated on a 4-point scale ranging from 1 (“not at all”) to 4 (“very much”); 5 components used a binary response set (“yes” or “no”). Higher scores in the symptom scale amount to a higher level of symptomatology and a poor QoL.8

-   Procedure for measurements including the process of standardization, standard protocol will be adapted to record indices, and WHO Oral Toxicity Scale.

Statistical Analysis

-  Descriptive Statistics will be calculated.

-   Mann-Whitney U test/Unpaired T test will be applied to assess significance difference between 2 group using SPSS v.21, with level of significance p < 0.05.

• McNemar test will be used to assess the changes in scale before and after intervention.

-   Repeated measure ANOVA will be applied to assess the oral hygiene over period of time.

Tangible outcome

-  The primary outcome will be to improve oral health status of cancer patients which will be evident clinically with reduced dental caries and gingival scores.

•  Prevention of Complications: Early intervention and preventive measures can significantly reduce the risk of severe oral complications.

-   Improved Quality of Life: By managing oral symptoms, patients can maintain better nutritional intake, experience less pain, and have a more positive treatment experience.

•   Enhanced Treatment Compliance: The oral complications are minimized; patients are more likely to complete their prescribed cancer treatment regimens.