Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT05273307|
Recruitment Status : Recruiting
First Posted : March 10, 2022
Last Update Posted : June 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Taste Dysfunction||Dietary Supplement: Miraculin Dietary Supplement: Miracle Fruit Placebo Cube||Phase 3|
This is a Phase III, single-center, double-blinded, placebo-controlled, randomized controlled trial.
I. To determine if the use of miracle fruit during radiation therapy for head and neck cancer patients can reduce the effect of subjective taste alteration influence on dietary intake.
I. To characterize changes in weight, quality of nutritional intake, patient-reported taste dysfunction and quality of life, frequency of significant medical events or treatment complications, and association between oral cavity radiation dose and dysgeusia.
Eligible participants will be randomized in a one-to-one ratio prior to beginning radiation treatment into one of two study arms and will be stratified according to treatment with or without concurrent chemotherapy.
ARM 1: Participants will receive a commercially available food/natural product (Miracle Fruit Farm miracle fruit cube), 1 cube by mouth three times a day before meals
ARM 2: Participants will receive a Miracle Fruit Farm placebo cube, 1 cube by mouth three times a day before meals
Participants may continue study treatment for 60 days from the time of initiating treatment and will be followed post-treatment for 180 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Packaging and labeling of test and control treatments will be identical and performed by Miracle Fruit Farm to maintain blinding conditions.|
|Primary Purpose:||Supportive Care|
|Official Title:||Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy: A Double-blinded, Placebo-controlled, Randomized Phase III Trial|
|Actual Study Start Date :||March 4, 2022|
|Estimated Primary Completion Date :||April 30, 2024|
|Estimated Study Completion Date :||April 30, 2025|
Experimental: Miracle Fruit
Participants will receive 1 Miracle Fruit Farm miracle fruit cube by mouth three times a day before meals
Dietary Supplement: Miraculin
Placebo Comparator: Miracle Fruit Placebo
Participants will receive 1 placebo cube by mouth three times a day before meals
Dietary Supplement: Miracle Fruit Placebo Cube
Other Name: Placebo
- Change in Taste Assessment scores over time [ Time Frame: 21 days ]The Taste Assessment is a two-item questionnaire used to determine the overall experiences of the participant taste sensation in the past 7 days; with one item asking about taste alteration and another asking about the interference of taste alteration with dietary intake. Scores for each item are obtained by responses to a Likert scale ranging from 1= "not at all" to 5="a lot", with greater scores indicating a greater taste alteration or interference.
- Change in body weight over time [ Time Frame: Up to 6 months ]Participants weight will be measured over the course of the study to be used in assessing whether miracle fruit affects maintenance of nutritional status during treatment.
- Change in Diet Diversity Scores over time [ Time Frame: Up to 6 months ]The Diet Diversity Score is a measure developed by the Food and Agriculture Organization of the United Nations as a rapid tool to assess nutrient adequacy of an individual's diet. The individual is asked to record all foods and drinks consumed in the previous day, which are then reviewed by the investigator and sorted into a list of nine food groups. The presence of a consumed food in a food group is assigned a score of one and if no food was consumed in a certain food group, then a score of zero is assigned. The individual Diet Diversity Score is then scored on a scale of 0-9 by adding the score from each food group. A higher score corresponds to higher diet diversity.
- Change in Chemotherapy-induced taste alteration scale (CiTAS) scores over time [ Time Frame: Up to 6 months ]The CiTAS consists of an 18-item survey designed to evaluate four different domains of taste alteration: Decline in basic taste (5 items), discomfort (6 items) , phantogeusia and parageusia (3 items), and general taste alterations (4 items). Each item response score ranges from 1 = no difficulty or absence of the disturbance to 5 = maximum difficulty or disturbance. Scores for each domain can be calculated taking the cumulative score of all items within each domain and dividing by number of items with higher scores indicating a greater level of difficulty or disturbance.
- Change in the Bernhardson Questionnaire scores over time [ Time Frame: Up to 6 months ]The Bernhardson Questionnaire is a two-item survey with assess taste and smell changed in chemotherapy patients and the impact it may have on quality of life. Each item is scored on a Likert scale of 1="not at all" to 4="very much", with an option of "N/A (no taste in change)". The total score is obtained by summing the item scores for a total of 8 possible with higher scores indicating a greater impact to quality of life.
- Change in the European Organization for Research and Treatment of Head and Neck (EORTC QLQ-H&N35) scores over time [ Time Frame: Up to 6 months ]The EORTC QLQ-H&N35 measures the impact symptoms experienced by head and neck cancer participants have on their quality of life. The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. The overall score consists of responses to the 35 items with responses ranging from 1="not at all" to 4="very much". The raw score is calculated by estimating the mean of each subscale with a resulting total range of 1-4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A higher score indicates a lower quality of life.
- Change in EuroQol five-dimensional Questionnaire (EQ-5D) scores over time [ Time Frame: Up to 6 months ]EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension by selecting one of the following responses: no problems (0), slight problems (1), mild problems (2), moderate problems (3), or severe problems (4) with a particular dimension. Lower scores indicate less issues/problems with that particular health dimension.
- Proportion of participants requiring percutaneous gastric tubes (PEG) over time [ Time Frame: Up to 6 months ]The proportion of participants who reported requiring the implementation of a PEG will be reported by treatment group over time.
- Proportion of participants requiring hospital admission over time [ Time Frame: Up to 6 months ]The proportion of participants who require hospitalizations related to lack of nutrition or failure to thrive will be reported by treatment group over time.
- Number of participants who returned unused product [ Time Frame: At 60 days ]Participants in each group will be requested to return any unused product at the end of treatment. The total number of participants who returned unused product during the treatment period will be reported by group.
- Number of participants who returned weekly recall items [ Time Frame: At 60 days ]Participants in each group will be requested to answer a weekly recall item as too how compliant they were in taking the study product 3 times a day each day and return this survey at the end of treatment. The total number of participants who returned the weekly recall surveys during the treatment period will be reported by group.
- Percentage of participants compliant with study treatment [ Time Frame: At 60 days ]Percent compliance by group will be calculated using the number of days on therapy divided by number of days should be on therapy multiplied by 100, using the weekly recall item and returning remaining study doses as verification of compliance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273307
|Contact: Jamese Johnson||(415) 476-3048||Jamese.Johnson@ucsf.edu|
|Principal Investigator:||Sue Yom, MD, PhD||University of California, San Francisco|