Smartphone Pain App for Assessing Oral Mucositis Pain in Patients

Stopped early

Conditions studied: Oral Mucositis

In brief

This research is being done to evaluate whether or not the Oral Mucositis (OM) Pain App (a smartphone application) is a feasible and valid tool to assess pain from radiation sores (also referred to as "mucositis") when treating head and neck cancers with radiation. The mobile app will be designed to help people better understand the pain from the radiation sores.

Key facts

Study ID

NCT02727062

Run by

Stuart Wong

People needed

18

Starts

2018-02-13

Expected to finish

2019-08-21

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically confirmed malignancy (including non-squamous cell histologies and unknown primary tumors).
• Patient must be undergoing a course of radiation therapy (RT) (with or without chemotherapy) including oral cavity and/or oropharynx to a dose of at least 50 Gy (SBRT is not allowed).
• Prior definitive course of RT is allowed.
• Physical exam demonstrating no preexisting mucositis.
• Ability to complete the questionnaire.
• No current oral infection or ongoing toxicity from prior radiotherapy.
• Zubrod Score/Eastern Cooperative Oncology Group (ECOG) Performance status < 2.
• Age ≥ 18 years.
• Concurrent enrollment on interventional trial is allowed.
• English-speaking and literate.

You may not qualify if…

• Nasopharyngeal cancer
• Paranasal sinus tumors
• Laryngeal cancer
• Pregnant or lactating women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus.

Where it is running

• Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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