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Completed

NCT Number: NCT03552965

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

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.

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Key information

Conditions

Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Salivary Gland Diseases Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases Xerostomia

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

This is a prospective randomized pilot clinical trial, stratified by primary tumor site, to evaluate the degree of xerostomia and quality of life (QOL) in subjects with HN-SQCC treated with radiation therapy under margin-based and robust radiotherapy treatment plans. Margin-based plans will use both biological (biological optimization) and physical objectives whereas robust planning will use physical objectives for sparing of the parotid glands. Intensity-modulated radiation therapy (IMRT) and standard chemotherapy will be used. QOL (quality of life) will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire and EORTC QLQ-H&N35 (head and neck) module before radiotherapy (baseline) and then 3, 6, 9 and 12 months after radiotherapy. Xerostomia will be measured in study subjects using two patient-reported scoring systems completed by each subject before radiotherapy and then 3, 6, 9, and 12 months after radiotherapy: Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) LENT/SOMA grading system and the University of Michigan's Xerostomia Questionnaire (XQ). The data collected by this randomized pilot clinical trial will be used to inform the design of, and decision-making for, future larger studies that seek to compare different methods of radiotherapy planning in the treatment of HN-SQCC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robust Radiotherapy planning

Other

Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue

Margin-Based Radiotherapy planning

Other

Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area

Primary outcomes

  1. Grade of Xerostomia

    Time frame: Baseline

    Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

  2. Grade of Xerostomia

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

    Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

  3. Grade of Xerostomia

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

    Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

  4. Grade of Xerostomia

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

    Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

  5. Grade of Xerostomia

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

    Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

  6. Prevalence of Xerostomia

    Time frame: Baseline

    Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.

  7. Prevalence of Xerostomia

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

    Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.

  8. Prevalence of Xerostomia

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

    Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.

  9. Prevalence of Xerostomia

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

    Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.

  10. Prevalence of Xerostomia

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

    Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

Prospective Randomized Pilot Clinical Trial of Margin-Based Vs. Robust Photon Radiotherapy Planning in Intensity-Modulated Radiation Therapy of Squamous-Cell Carcinoma of the Head and Neck

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Jun 12, 2018
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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