Dataset Information

Evaluating Ayurvedic mouthwash and soda-salt mouthwash for oral mucositis in head and neck cancer: A randomized controlled trial.

ABSTRACT:

Background

Patients undergoing radiotherapy (RT) or concurrent chemo-radiation (CCRT) for head and neck squamous cell carcinoma (HNSCC) often suffer from side effects such as mucositis, xerostomia, pharyngitis, laryngitis, and pain, which are being managed symptomatically by alcohol-based mouthwashes.

Objectives

To determine the effectiveness of Ayurvedic mouthwash "Draksha Guduchyadi Kashaya" in reducing the severity of oral side effects of chemo-radiation.

Material and methods

This concurrent parallel randomized controlled study was conducted at Sir Sunderlal Hospital, BHU, on 70 HNSCC patients scheduled to undergo RT/CCRT. Patients who met the inclusion-exclusion criteria were enrolled, and 35 were randomly assigned to either the intervention group (Ayurveda) or the control group using a simple random technique (lottery method). Blinding was not implemented in this study. Patients in the intervention group (Ayurveda) were instructed to perform kavala with 50 ml of "Draksha Guduchyadi Kashaya" for 2 min, ten times daily, while the control group performed 2-min gargling with soda-salt mouthwash ten times daily.

Results

Out of the 70 patients enrolled, data from 60 patients were analyzed, revealing statistically significant differences in the onset of mucositis (p = 0.049), pharyngitis (p = 0.034), laryngitis (p = 0.009) and intensity of variables such as mucositis (p = 0.000), xerostomia (p = 0.046), pharyngitis (p = 0.002), laryngitis (p = 0.035), and pain (p = 0.000). These findings indicate that Ayurvedic mouthwash may be beneficial in managing the oral side effects of chemo-radiation in HNSCC.

Conclusion

This AYUSH financially supported trial (Reg No: CTRI/2020/04/024672) demonstrates promise as a safe and cost-effective alternative for managing oral complications of RT/CCRT, offering complementary treatment for comprehensive cancer care.

SUBMITTER: Saniya CK

PROVIDER: S-EPMC10698543 | biostudies-literature | 2023 Nov-Dec

REPOSITORIES: biostudies-literature

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Publications

Evaluating Ayurvedic mouthwash and soda-salt mouthwash for oral mucositis in head and neck cancer: A randomized controlled trial.

Saniya C K CK Rao Mangalagowri V MV Patil Rajkala R Choudhary Sunil S Singh Om Prakash OP Dhiman K S KS

Journal of Ayurveda and integrative medicine 20231128 6

<h4>Background</h4>Patients undergoing radiotherapy (RT) or concurrent chemo-radiation (CCRT) for head and neck squamous cell carcinoma (HNSCC) often suffer from side effects such as mucositis, xerostomia, pharyngitis, laryngitis, and pain, which are being managed symptomatically by alcohol-based mouthwashes.<h4>Objectives</h4>To determine the effectiveness of Ayurvedic mouthwash "Draksha Guduchyadi Kashaya" in reducing the severity of oral side effects of chemo-radiation.<h4>Material and method ...[more]

PMID: 38029523

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Project description:BackgroundPredicting the occurrence and/or severity of oral mucositis (OM) before commencing radiotherapy (RT) remains very difficult. The aim of this prospective trial was to investigate whether the ex-vivo radiation sensitivity of oral keratinocytes from head and neck (H&N) cancer patients correlates with severe OM.MethodsOral microbiopsies of healthy gingival mucosa were collected from 63H&N cancer patients undergoing (chemo)RT, of which 58 samples were useable. Keratinocytes from these microbiopsies underwent ex-vivo proliferation, irradiation, and subsequently the cell spreading assay. Tubes with the cell suspension were placed within the irradiation chamber of a 137Cs Gammacell 40 Exactor (Best Theratronics, Canada) and exposed to 0, 2, 4, 6, or 8 Gy at a dose rate of 0.63 Gy min-1. Cell suspension was then immediately pipetted into custom-made polydimethylsiloxane (PDMS) rings.The effect of demographic and clinical parameters on the cell spreading assay were also analyzed. Systematic clinical recording of OM was conducted twice a week by a specially trained examiner.ResultsMost patients had node-positive disease and cancer of the oropharynx or oral cavity. The vast majority of patients received adjuvant RT and concurrent chemotherapy. Overall, 34 (58.6 %) participants developed grade 3 OM after a median dose of 32 Gy. No patient experienced a grade ≥ 4 event. There was a correlation between the cell spreading assay area and grade 3 OM (p < 0.05), equivalent to approximately 0.5 Gy dose. Demographic and clinical parameters had no significant impact on the cell spreading assay (p > 0.05 for all).ConclusionsIt is necessary to establish reliable predictors of severe OM before treatment in H&N cancer to allow early management of treatment-related sequelae. This prospective trial illustrates that the intrinsic ex-vivo radiosensitivity of oral keratinocytes could be correlated with RT-induced OM in patients with H&N cancer. This novel predictor requires validation in larger prospective cohorts.

Project description:ImportanceOral mucositis (OM) is a common and debilitating adverse effect observed in patients with head and neck cancer (HNC) receiving radiation therapy (RT). Previous studies examining associations between OM and clinical outcomes were performed in the era of 3-dimensional conformal RT planning with low rates of concurrent chemotherapy, and thus may not reflect current practice.ObjectiveTo prospectively assess patient-reported OM and identify its associations with clinical outcomes and quality of life.Design, setting, and participantsThis cohort study performed at a single institution included 702 consecutive patients who underwent definitive or adjuvant intensity-modulated RT (IMRT) for primary HNC from February 9, 2015, to May 27, 2022. Data were analyzed from November 28, 2022, to August 18, 2023.Main outcomes and measuresSeverity of OM was assessed based on highest reported mouth and throat soreness (MTS) score during radiotherapy according to the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer survey, which was administered weekly during IMRT. Linear mixed models were used to compare mean MTS scores grouped by disease site and chemotherapy regimen. Fisher exact tests and 1-way analysis of variance tests were performed to identify associations between severity of OM and clinical outcomes.ResultsAmong 576 eligible patients, the median age was 62.5 (IQR, 56.3-69.1) years, and 451 patients (78.3%) were men. In terms of race and ethnicity, 6 patients (1.0%) were American Indian or Alaska Native; 2 (0.3%), Asian; 31 (5.4%), Black; 8 (1.4%), Hispanic or Latino; 509 (88.4%), White; and 28 (4.9%), unknown. The most common treatment site was oropharynx (268 [46.5%]), and most patients received concurrent chemotherapy (464 [80.6%]). By the end of treatment, 360 patients (62.5%) developed severe OM and 568 (98.6%) developed some degree of OM. Linear mixed models found no significant differences in OM between HNC disease sites. Groups with greater highest severity of OM reported had higher rates of measured outcomes (listed respectively by MTS score 0, 1, 2, 3, and 4): feeding tube placement (0%, 3.6% [2 of 56], 6.6% [10 of 152], 14.7% [40 of 272], and 21.6% [19 of 88]; P = .001), hospitalization (12.5% [1 of 8], 10.7% [6 of 56], 15.1% [23 of 152], 23.9% [65 of 272], and 28.4% [25 of 88]; P = .02), opiate use (0%, 19.6% [11 of 56], 42.8%[65 of 152], 61.4% [167 of 272], and 64.8% [57 of 88]; P < .001) and experienced greater weight loss (median, -0.7 [IQR, -1.7 to -0.4] kg; median, 3.9 [IQR, 1.1 to 6.1] kg; median, 5.0 [IQR, 2.2 to 7.7] kg; median, 4.7 [IQR, 2.1 to 7.7] kg; and median, 7.7 [IQR, 2.8 to 10.6] kg; P < .001).Conclusions and relevanceIn this cohort study of patients with HNC, 62.5% developed severe OM. Higher severity of OM was associated with feeding tube placement, hospitalization, opiate use, and weight loss. Improvements in OM prevention and management are needed.

Dataset Information

Evaluating Ayurvedic mouthwash and soda-salt mouthwash for oral mucositis in head and neck cancer: A randomized controlled trial.

Background

Objectives

Material and methods

Results

Conclusion

Publications

Evaluating Ayurvedic mouthwash and soda-salt mouthwash for oral mucositis in head and neck cancer: A randomized controlled trial.

Similar Datasets

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