Effect of Dried Miracle Berry on the Olfactory-gustative Perception in Malnourished Cancer Patients

Plain-language summary

This study examines the effect of dried miracle berry on smell and taste perception in malnourished cancer patients. It enrolled cancer patients over 18 who had weight loss and taste disturbances and were receiving chemotherapy or chemo-radiotherapy. It was a study without a phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Intervention

DMB lowest dose, DMB highest dose, Strawberry lyophilisate

Start date

6/23/2022

Estimated completion

9/30/2023

Countries

Spain

Related genes

Locations

• Madrid, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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