Effect of Dried Miracle Berry on the Olfactory-gustative Perception in Malnourished Cancer Patients (NCT05486260) | Clinical Trial Compass
CompletedNot Applicable
Effect of Dried Miracle Berry on the Olfactory-gustative Perception in Malnourished Cancer Patients
Spain21 participantsStarted 2022-06-23
Plain-language summary
Cancer is one of the main causes of death globally, being in many countries the first cause of mortality. One of the main side effects of chemotherapy and/or radiotherapy treatment in cancer patients is the alteration of taste and smell, internationally known as these anomalies Taste Smell Alterations (TSA). These alterations are the result of an altered cellular structure, the presence of TSA is associated with reduced quality of life and poor nutrition, due to dietary changes made by these patients.
Synsepalum dulcidicum (dried miracle berry, DMB) is a plant belonging to the Sapotaceae family, made up of around 800 species grouped into around 40 genera. It is an indigenous species to the forest regions of West Africa. Nuts of this specie have been approved as a novel food in accordance with Regulation (EU) 2015/2238 and at the request of the European Commission through the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens. The characteristic component of DMB is miraculin. Miraculin is a glycoprotein whose consumption causes acidic and sour foods, and to a lesser extent bitter, to be perceived as having a sweet taste. In this sense, it is possible that the consumption of DMB before each meal can improve sensory perception after treatment with chemotherapy or radiotherapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women over 18
* Patients with a weight loss \>=5 %
* Patient with malnutrition assessed by Global Leadership Initiative on Malnutrition (GLIM) Criteria
* Patients with taste alterations measured by electrogustometry
* Cancer patients treated with neoadjuvant chemotherapy prior to surgery, chemotherapy or chemo-radiotherapy who are not candidates for surgery.
* Patients with less than or equal to one third of chemotherapy and/or radiotherapy treatment initially scheduled.
* Patients with a life expectancy greater than 3 months.
* Patient with oral intake of food and drinks.
* Adequate cultural level and understanding of the clinical study.
* Agree to voluntarily participate in the study and give their signed written informed consent.
Exclusion Criteria:
* Patients who are participating in other clinical trials.
* Patients with a weight loss \< 5%
* Patients with a parenteral o enteral nutrition
* Patients diagnosed with poorly controlled Diabetes Mellitus (HbA1 c\>8%)
* Patients with uncontrolled high blood pressure.
* Patients with uncontrolled hyper/hypothyroidism.
* Patients with severe digestive toxicity due to treatment with chemo-radiotherapy
* Patients with a life expectancy of less than 3 months.
* Patients diagnosed with severe kidney or liver disease (chronic kidney failure, nephrotic syndrome, cirrhosis).
* Patients with severe dementia, brain metastases, eating behavior disorders, history of serious neurological or psychiatric patho…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Electrogustometry
Timeframe: Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)
2
Sniffing Stick Smell Test
Timeframe: Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)
3
Strips' Test
Timeframe: Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)
4
Taste and Smell Survey
Timeframe: Before chemotherapy, After therapy (3-4 days), Follow up (1 month, 2 months and 3 months after chemotherapy)
Trial details
NCT IDNCT05486260
SponsorInstituto de Investigación Hospital Universitario La Paz