N/A N=23 Randomized Supportive Care

Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC

Squamous Cell Carcinoma of the Head and Neck

Bottom Line

View on ClinicalTrials.gov: NCT03552965 ↗

Enrolled (actual)

Serious AEs

30.4%

Results posted

May 2025

Primary outcome: Primary: Grade of Xerostomia — 1.14; 1.17 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Robust Radiotherapy planning (Other); Margin-Based Radiotherapy planning (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Arkansas
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Grade of Xerostomia	2.00; 2.38	—
PRIMARY Grade of Xerostomia	2.00; 2.38	—
PRIMARY Grade of Xerostomia	2.00; 2.38	—
PRIMARY Grade of Xerostomia	2.00; 2.38	—
PRIMARY Grade of Xerostomia	2.00; 2.38	—
PRIMARY Prevalence of Xerostomia	50.75; 38.4375	—
PRIMARY Prevalence of Xerostomia	50.75; 38.4375	—
PRIMARY Prevalence of Xerostomia	50.75; 38.4375	—
PRIMARY Prevalence of Xerostomia	50.75; 38.4375	—
PRIMARY Prevalence of Xerostomia	50.75; 38.4375	—

Summary

This is a research study to evaluate the quality of life and amount of dry mouth experienced as a result of radiotherapy in subjects who have squamous cell carcinoma of the head and neck (HN-SQCC). This study will compare the side effects experienced based on the method to plan radiotherapy, Margin Based or Robust.

Eligibility Criteria

Inclusion Criteria

Histological documentation of Squamous-Cell Carcinoma of the Head and Neck (HN-SQCC)
Older than 21 years of age
Subject is eligible for routine chemo-radiotherapy for treatment of HN-SQCC
Informed consent is obtained
Karnofsky performance of at least 70 points

Exclusion Criteria

Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential must agree to refrain from breast feeding and practice adequate contraception
Unable to comply with study procedures
Use of saliva stimulating prescription drugs such as Evoxac or Salagen
Unable to receive standard chemotherapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03552965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.