Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 12
- 主要终点
- Patient-generated Subjective Global Assessment (PG-SGA) Score
研究概览
简要总结
The study investigates taste disorders that commonly occur during or after cancer treatment, often leading to issues such as malnutrition and treatment discontinuation. Although many non-pharmacological recommendations exist, it is unclear which methods are suitable for which individuals.
This randomized study aims to compare the effectiveness of individualized dietary recommendations (Gustabor group) with the current standard of care -general recommendations (Control group). Participants will undergo an objective assessment of taste disorders using taste strips and questionnaires. Based on the results, the Gustabor group will receive both general and specific dietary suggestions. These will be accomapnied by AI-generated recipe suggestions tailored to specific taste disorders (e.g., more cold foods in cases of metallic taste). The control group will receive the current standard: a flyer containing general dietary advice for oncology patients previously shown to be beneficial for managing taste alterations. The primary endpoint is the PG-SGA score within 12 weeks of inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suffering from one of the following tumor entities: Multiple myeloma, melanoma, urogenital cancer or malignant tumor of the gastrointestinal tract
- •Mainly oral nutrition
- •Subjectively perceived tumor therapy-related taste disorder
- •At least two clinical presentations planned within 12 weeks with a minimum interval of three weeks
- •Ability to participate in nutritional intervention, including use of the online portal and implementation of recipe suggestions (e.g. resources and access to a kitchen), either independently or with third-party support (e.g. by relatives, outpatient care services).
排除标准
- •Pregnancy
- •Taste disorder explained by other causes (e.g. existing before therapy or COVID disease)
- •Placement in an inpatient care facility
研究组 & 干预措施
Gustabor Group
Gustabor server: Receives general and specific nutrition recommendations, as well as lifestyle tips and recipes based on the patient's individual taste changes and preferences as identified by the AI based web platform
干预措施: Gustabor server (Other)
Control Group
Receives the current standard recommendations for taste disorders from scientifically published measures in form of a printed-out flyer.
干预措施: Standard Recommendations (Other)
结局指标
主要结局
Patient-generated Subjective Global Assessment (PG-SGA) Score
时间窗: Within 12 weeks of inclusion
PG-SGA measures four key areas: weight history, including recent unintentional weight loss; the presence of nutrition-impacting symptoms such as nausea, taste changes, and appetite loss; current food intake compared to normal levels; and functional status, which measures the ability to perform daily activities. Based on the responses, a numeric score is calculated, with higher scores indicating a greater risk of malnutrition and the need for dietary intervention.
次要结局
- Identification of measures that were perceived as helpful(Within 12 weeks of inclusion)
- Correlation of PG-SGA progression with individual taste perceptions, tumor type and ongoing tumor therapy(Within 12 weeks of inclusion)
- Correlation of PG-SGA progression (PG-SGA Questionnaire) with individual taste perceptions (taste strips), tumor type and ongoing tumor therapy (questionnaire)(Within 12 weeks of inclusion)