CompletedNot Applicable

Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer

Mexico40 participantsStarted 2010-12

Plain-language summary

One of the most widely used treatments for non-small cell lung cancer (NSCLC) is the combination of paclitaxel-cisplatin. These drugs may contribute to taste alterations like dysgeusia. Which alters the feeding of cancer patients, contributing to the anorexia, weight loss and malnutrition, which leads to a prognostic impact in a lower patient response to chemotherapy, radiotherapy and surgical treatment as well as increased toxic effects, impacting treatment discontinuation and therefore, morbidity and survival of patients. The objective of this study is to describe the threshold of perception and recognition of basic tastes in patients with NSCLC before treatment with platin and paclitaxel-based chemotherapy and after the second cycle, and analyze the effect in the developement of dysgeusia, as well as the association between these and the nutritional status and quality of life.

Who can participate

Age range

18 Years – 90 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: * Patients over 18 years old with INCan histopathological diagnosis of Lung Cancer Stage III or IV * ECOG score ≤ 2 * Candidates for first-line chemotherapy based 1 st Paclitaxel / cisplatin 200 mg/m2 and 75 every 3 weeks * Signed informed consent (and ethical scientific committee No. (010/023 (IMO) (CB/618 Exclusion Criteria: * Patients who withdraw their consent and not want to continue with the evaluation of the study * Common cold or hay fever, recent dental procedure, evidence of gingival inflammation or infection or oral mucosa * People diagnosed with epilepsy or some other neurological disorders associated * Concomitant radiotherapy in head and neck.

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

Dysgeusia (UMAMI Perception)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (UMAMI Recognition)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (SWEET Perception)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (SWEET Recognition)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (BITTER Perception)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (BITTER Recognition)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (UMAMI Dilutions Dichotomized)

Timeframe: pre - post chemotherapy (6 weeks)

Trial details

NCT IDNCT01540045

SponsorInstituto Nacional de Cancerologia de Mexico

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-12

Results submitted2013-07-23

View on ClinicalTrials.gov More Non-Small Cell Lung Cancer trials

Plain-language summary

Who can participate

Age range

18 Years – 90 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.

What they're measuring

Dysgeusia (UMAMI Perception)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (UMAMI Recognition)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (SWEET Perception)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (SWEET Recognition)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (BITTER Perception)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (BITTER Recognition)

Timeframe: Change from Baseline in threshold of perception at 6 weeks

Dysgeusia (UMAMI Dilutions Dichotomized)

Timeframe: pre - post chemotherapy (6 weeks)