cancer malignancy cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: * Age >=18 and <=70 years * Indication to start chemotherapy for: o Triple negative breast cancer o Testicular cancer o Stage II-IV diffuse large B cell lymphoma - Chemotherapy scheduled during the next 6 weeks - Consuming solid foods and drinks is possible - <=50% of recommended daily intake in kcal consisting of oral nutritional supplements - Oral mucositis grade <=2 (Common Terminology Criteria for Adverse Events, version 5.0) - Ability to comply with all protocol-required actions - Provide written informed consent - For the intervention phase only: subjective change in taste since start of chemotherapy
Exclusion criteria
Exclusion criteria: * Pregnancy - Currently experiencing taste or smell problems - Previous or current radiotherapy of head and neck region - Enteral feeding through tube or parenteral feeding - Participation in another clinical trial aimed at preventing or treating taste and/or smell alterations - Chronic (>1 month) high dose corticosteroids (>10 mg prednisone/day or equivalent).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Food enjoyment, measured by the subsection of the Appetite, Hunger and Sensory Perception Questionnaire (AHSP) after 6 weeks of taste steering compared with standard care. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Food enjoyment and food liking, measured by the questions on food enjoyment and food liking on 9-point hedonic scale; 2) Quality of life: EORTC QLQ-C30; 3) Taste and smell alterations: Chemotherapy-induced Taste Alteration Scale (ciTAS-NL); 4) Risk of malnutrition: Patient-Generated Subjective Global Assessment (PG-SGA); 5) Dry mouth feeling: Xerostomia Inventory (XI) and Regional Oral Dryness Inventory (RODI); 6) Taste and smell function; taste strips and smell sticks 7) Saliva secretion and composition; 8) Body weight. Endpoints will be measured at baseline, when taste alterations occur and after 6 weeks. | — |
Countries
Netherlands
Contacts
Universitair Medisch Centrum Groningen