Breast CancerNCT04543175
Taste Disorders and Their Relation to BMI, FFQ, and EORTC QLQ-BR23 in Breast Cancer Patients During Chemotherapy.
An observational study of Breast Cancer and Taste Disorders, run by Hospital General de Mexico at 1 site in Mexico.
Trial summary
Taste disorders in cancer patients during chemotherapy could be consider as multifactorial disease, it is related with changes of food consumption. Approximately 36-69% of the patients under chemotherapy suffer oral toxicity or dysgeusia A prospective case- only observational study was conducted in patients of the… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Taste Disorders, Dysgeusia
- What is being tested?
- Taste disorder´s test
- How many people
- 106 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2017to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients of Oncology ward in Hospital General de Mexico between 20 and 60 years old with newly diagnosed breast cancer. and chemotherapy with Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel.
Who may be able to join
- Chemotherapy with Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel.
- Exclusión Criteria:
- No smokers Infections in oral cavity Acute respiratory diseases Gastro- oesophageal reflux disease Other types of cancer.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taste Disorders and Their Relation to Body Mass Index, Food Frequency Questionnaire and Quality of Life in Breast Cancer Patients During Chemotherapy.
Taste disorders in cancer patients during chemotherapy could be consider as multifactorial disease, it is related with changes of food consumption. Approximately 36-69% of the patients under chemotherapy suffer oral toxicity or dysgeusia
A prospective case- only observational study was conducted in patients of the Hospital General de México for two years. A self-reported taste survey was used, and patients scored their results in a Likert scale.
- Conditions
- Breast Cancer, Taste Disorders, Dysgeusia, Ageusia, Quality of Life
- Being tested
- Taste disorder´s test
- Medical subject headings
- Breast Neoplasms, Taste Disorders, Dysgeusia, Ageusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taste disorder´s testOther
Also called Taste disorders
Each patient performed their own test placing three drops with a disposable dropper from each bottle into the center of the tongue for whole-mouth testing.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy breast cancer patients | Newly diagnosed breast cancer patients (clinical stages IA, IIA, IIB, IIIA and IIIB) before and after chemotherapy with the following drugs (Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel were followed until they complete four cycles of chemotherapy. Receives: Other: Taste disorder´s test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of taste disorders and perception of the four basic flavors
to assess the prevalence of taste alterations perception of the four basic flavors (sweet, salty, bitter and acidic) in newly diagnosed breast cancer patients (clinical stages IA, IIA, IIB, IIIA and IIIB) before and after chemotherapy
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Vanessa Fuchs Tarlovsky, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543175
- Sponsor's protocol ID
- DI/13/111/04/0249
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Disorders and Their Relation to Body Mass Index, Food Frequency Questionnaire and Quality of Life in Breast Cancer Patients During Chemotherapy.
- ClinicalTrials.gov ID
- NCT04543175
- Acronym / sponsor ID
- DI/13/111/04/0249
- Conditions
- Breast Cancer, Taste Disorders, Dysgeusia, Ageusia, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Taste disorders in cancer patients during chemotherapy could be consider as multifactorial disease, it is related with changes of food consumption. Approximately 36-69% of the patients under chemotherapy suffer oral toxicity or dysgeusia
A prospective case- only observational study was conducted in patients of the Hospital General de México for two years. A self-reported taste survey was used, and patients scored their results in a Likert scale.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy breast cancer patients | – | Other: Taste disorder´s testNewly diagnosed breast cancer patients (clinical stages IA, IIA, IIB, IIIA and IIIB) before and after chemotherapy with the following drugs (Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel were followed until they complete four cycles of chemotherapy. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients of Oncology ward in Hospital General de Mexico between 20 and 60 years old with newly diagnosed breast cancer. and chemotherapy with Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel.
Key inclusion criteria (3 listed)
- Chemotherapy with Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel.
- No smokers Infections in oral cavity Acute respiratory diseases Gastro- oesophageal reflux disease Other types of cancer.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taste disorder´s testAlso: Taste disordersEach patient performed their own test placing three drops with a disposable dropper from each bottle into the center of the tongue for whole-mouth testing. | Other | Chemotherapy breast cancer patients |
Primary outcome
Prevalence of taste disorders and perception of the four basic flavors
Time frame: 21 days
to assess the prevalence of taste alterations perception of the four basic flavors (sweet, salty, bitter and acidic) in newly diagnosed breast cancer patients (clinical stages IA, IIA, IIB, IIIA and IIIB) before and after chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Taste Disorders, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of taste disorders and perception of the four basic flavors (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.