Quercetin and Chemoradiotherapy versus Chemoradiotherapy Alone in p53-Mutated and Wild-Type Head and Neck Cancers

Combination of Quercetin with Chemoradiotherapy versus Chemoradiotherapy Alone in p53-Mutated and Wild-Type Head and Neck Cancers: An Interventional Pilot Study at a Tertiary Care Hospital in Prayagraj - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085926

Enrollment

100

Registered

2025-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R888- Abnormal findings in other body fluids and substances

Interventions

Intervention1: Quercetin LPX 1000: Quercetin LPX 1000 is a unique and highly bioavailable formulation that combines Quercetin 95% extracted from Sophora Japonica tree bark, Bromelain from Pineapple, a

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: i) Adults aged 18 or older with a confirmed diagnosis of a solid tumor. ii) Known p53 status (wild-type or mutated) based on biopsy. iii) Status of Case report for (CRF), WHO Toxicity Criteria, RECIST Criteria, Dysphagia Scoring System, UW-QOL v4 questionnaire and general questions to assess the overall quality of life. iv) Adequate organ function assessed by clinical & laboratory investigations and ability to provide informed consent.

Exclusion criteria

Exclusion criteria: i) Prior treatment with quercetin. ii) Uncontrolled comorbid conditions. iii) Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
Intervention with dosage forms of Qu+CRT (SoC) in p53 mutation positive Head and Neck Cancer and correlation with clinicopathological factors. Molecular Analysis: Pre- and post-treatment biopsies will be analyzed for markers of changes in p53 expression. Overall the role of intervention in restoring the mutation status of p53 and in stabilizing the status of p53 in wild type head and neck cancers. Timepoint: 4 weeks after the intervention status of p53 will be analysed using molecular methods.The study will go on till the estimated sample size is not achieved in arround 1 to 2 years.	—

Measure

Time frame

Intervention with dosage forms of Qu+CRT (SoC) in p53 mutation positive Head and Neck Cancer and correlation with clinicopathological factors. Molecular Analysis: Pre- and post-treatment biopsies will be analyzed for markers of changes in p53 expression. Overall the role of intervention in restoring the mutation status of p53 and in stabilizing the status of p53 in wild type head and neck cancers. Timepoint: 4 weeks after the intervention status of p53 will be analysed using molecular methods.The study will go on till the estimated sample size is not achieved in arround 1 to 2 years.

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Secondary

Measure	Time frame
Data Analysis: Statistical Methods: Description of statistical tests & software to be used (e.g., ANOVA, t-tests). Comparative Analysis: Assess differences in treatment efficacy based on p53 mutation status. Efficacy Analysis: Kaplan-Meier survival curves will be generated to evaluate Overall Survival (OS) & Progression Free Survival (PFS), with preliminary comparisons made between treatment arms. Subgroup Analysis: Exploratory analysis will be conducted to examine the effect of Qu in p53 mutated & wild type head & neck cancer. Timepoint: After 28 to 30 weeks of study, till the sample size is complete, data analysis will be done for the study.	—

Measure

Time frame

Data Analysis: Statistical Methods: Description of statistical tests & software to be used (e.g., ANOVA, t-tests). Comparative Analysis: Assess differences in treatment efficacy based on p53 mutation status. Efficacy Analysis: Kaplan-Meier survival curves will be generated to evaluate Overall Survival (OS) & Progression Free Survival (PFS), with preliminary comparisons made between treatment arms. Subgroup Analysis: Exploratory analysis will be conducted to examine the effect of Qu in p53 mutated & wild type head & neck cancer. Timepoint: After 28 to 30 weeks of study, till the sample size is complete, data analysis will be done for the study.

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Countries

India

Contacts

Public ContactDr Virendra Singh

Moti Lal Nehru Medical College Prayagraj

singhv2003@gmail.com8726913670

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026