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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT05486260
Eligibility Criteria:
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 pathology that may interfere with treatment.
* Patients suffering from alcoholism or substance abuse that may interfere with adherence to treatment.
* Patients with serious gastrointestinal diseases.
* Patients who reject the consumption of DMB.
* Pregnant or lactating women.
* Assessment that, in the clinician's opinion, prevents the patient from participating (severity, etc.)
Withdrawal Criteria:
\- Intolerance to the consumption of DMB or Placebo
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05486260
Study Brief:
Protocol Section:
NCT05486260