Trial · NCT01687413
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Disease-free Survival (DFS) | 1 year | |
| Primary | Locoregional Control | Up to 2 years | Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins. |
| Secondary | Rate of Distant Metastasis | Up to 2 years | Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone. |
| Secondary | Disease Specific Survival | 1 year | |
| Secondary | Number of Complications/Acute Toxicity by Organ Class | Approximately 18 weeks | -Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
| Secondary | Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory | Baseline, 1 month, 6 months, 12 months, and 24 months | * Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5 * The lower the score the lower the quality of life |
| Secondary | Change in Cognitive Function as Measured by Cognitive Failures Questionnaire | Baseline, 1 month, 12 months, and 24 months | * 25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering * Answers range from 0 = never to 4 = very often * The higher the score the worse the cognitive failures the participant has experienced |
| Secondary | Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII) | Baseline, 12 months, and 24 months | -The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from "not at all" to "a lot". The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot). |
| Secondary | Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire | Baseline, 1 month, 6 months, 12 months, and 24 months | * It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness. * The higher the score the worse the participant's xerostomia |
| Secondary | Change in Hearing as Measured by Hearing Handicap Inventory - Adult | Baseline, 1 month, and 12 months | * 11 item questionnaire to identify issues with hearing * Answers are yes = 4, sometimes = 2, and no = 0 * The higher the score the more issues the participant has with hearing |
| Secondary | Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity | Baseline, 1 month, 6 months, and 12 months | * 1 question that asks about taste acuity * Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity * The higher the score the worse the participant's taste acuity |
| Secondary | Change in Quality of Life as Measured by Speech Handicap Index | Baseline and 12 months | * 31 questions regarding participant's speech and the effects of speech on his/her life * The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4 * The higher the score the worse the participant's speech is affecting his/her life |
| Secondary | Change in Quality of Life as Measured by EORTC QLQ-C30 | Baseline, 1 month, 6 months, 12 months, and 24 months | * 30 questions designed to assess the quality of life of cancer patients * The first 28 questions have answers that range from 1=not at all to 4 = very much. The higher score indicates a worse quality of life * The last 2 questions have answers that range from 1 = very poor to 7 = excellent. The higher score indicates a better quality of life |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01687413/registered