| NCT ID | NCT06669416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Chemotherapy Side Effects |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2024-12-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main questions it aims to answer are: 1. Does completing a standard assessment increase the detection of chemotherapy induced taste changes compared with usual care (no assessment)? What TA are experienced? Are there any patterns in TA symptom occurrence based on age, sex, race/ethnicity, cancer type, chemotherapy agent, etc. 2. Do patients take action to deal with the TA? What strategies are used? Do patients in the intervention group use the assessments to select interventions? 3. Do the interventions lessen TA symptoms and maintain food intake? Is the treatment (in-depth assessment and education) more effective in lessening the intensity of TA than usual care? Which level of assessment is needed to support symptom management to reduce symptom severity? Participants will: Complete baseline assessment before starting their initial chemotherapy infusion (all patients) Participate in baseline patient education based on assigned intervention (usual care vs. treatment) Engage in TA management between chemotherapy infusion clinic visits based on education Visit the clinic for chemotherapy infusions as scheduled; Complete TA assessments and reporting based on intervention; Work with nurse coaches to answer questions and help with the intervention. Complete study data collection on the 4th chemotherapy cycle (but continue intervention) Complete final data collection at 6 months
Eligibility Criteria
Inclusion Criteria: * Medical diagnosis of cancer with types limited to the top cancer types \[Note: Cancer types that are rare will be excluded\] * Initiating chemotherapy (first day/first cycle) at participating clinics * English speaking/reading (without an interpreter) Exclusion Criteria: * Substitute decision-maker (activated) * History of head/neck cancer or irradiation * Known genetic/metabolic disorder impacting taste (preexisting dysgeusia) * Known eating disorder * Receiving enteral or parenteral nutrition (special nutritional needs) * Pregnant women (unique needs) * Patients with medical orders for end of life/hospice care
Contact & Investigator
Mary L Hook, PhD, RN
PRINCIPAL INVESTIGATOR
Aurora Sinai Medical Center
Frequently Asked Questions
Who can join the NCT06669416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy Side Effects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06669416 currently recruiting?
Yes, NCT06669416 is actively recruiting participants. Contact the research team at mary.hook@aah.org for enrollment information.
Where is the NCT06669416 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06669416 clinical trial?
NCT06669416 is sponsored by Wake Forest University Health Sciences. The principal investigator is Mary L Hook, PhD, RN at Aurora Sinai Medical Center. The trial plans to enroll 400 participants.