CompletedNot Applicable

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

United States23 participantsStarted 2018-06-19

Plain-language 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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Grade of Xerostomia

Timeframe: Baseline

Grade of Xerostomia

Timeframe: Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)

Grade of Xerostomia

Timeframe: Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)

Grade of Xerostomia

Timeframe: Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)

Grade of Xerostomia

Timeframe: Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)

Prevalence of Xerostomia

Timeframe: Baseline

Prevalence of Xerostomia

Timeframe: Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)

Prevalence of Xerostomia

Timeframe: Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)

Trial details

NCT IDNCT03552965

SponsorUniversity of Arkansas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-09

Results submitted2025-02-26

View on ClinicalTrials.gov More Squamous Cell Carcinoma of the Head and Neck trials

Plain-language summary

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Grade of Xerostomia

Timeframe: Baseline

Grade of Xerostomia

Timeframe: Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)

Grade of Xerostomia

Timeframe: Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)

Grade of Xerostomia

Timeframe: Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)

Grade of Xerostomia

Timeframe: Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)

Prevalence of Xerostomia

Timeframe: Baseline

Prevalence of Xerostomia

Timeframe: Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)

Prevalence of Xerostomia

Timeframe: Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)