Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01596634
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed colorectal carcinoma
* There are no restrictions on the amount or types of prior therapy
* Eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial
* Any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either:
* 1\) developed since the initiation of oxaliplatin-based therapy, or
* 2\) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating oxaliplatin-based therapy
* Patients must have normal baseline self-reported taste perception prior to the development of colorectal carcinoma
* Life expectancy of \>= 3 months
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately 2 mL in 15-20 min)
* Patients known to be human immunodeficiency virus (HIV)-positive
* Patients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositis
* Patients who are known to be pregnant or who are breastfeeding are excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01596634
Study Brief:
Protocol Section:
NCT01596634