Study on Swallowing and Quality of Life in Advanced Head and Neck Cancer Patients Using Cisplatin and Drug Combination

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What is this study about?

This clinical trial focuses on patients with advanced head and neck cancer, specifically those with oropharyngeal cancer. The study aims to understand how different approaches to feeding tube placement affect patients’ ability to swallow and their overall quality of life after receiving a combination of chemotherapy and radiation therapy. The chemotherapy treatment involves the use of cisplatin, a medication given through an injection into a vein. The study will compare two groups of patients: one group will receive a feeding tube before starting treatment (prophylactic), and the other group will receive a feeding tube only if it becomes necessary during treatment (reactive).

In addition to cisplatin, the study involves the use of iomeprol, barium sulfate, and fludeoxyglucose (18F). Iomeprol and fludeoxyglucose (18F) are solutions for injection, while barium sulfate is taken orally. These substances are used to help visualize the body during imaging tests, which are part of the study’s assessments. The purpose of the study is to evaluate patient-reported outcomes, such as swallowing ability and quality of life, six months after completing treatment. This will help determine the best approach to managing feeding needs in patients undergoing treatment for head and neck cancer.

Participants in the study will be monitored over a period of time, with regular assessments to track their progress and any side effects they may experience. The study will also collect information on the impact of treatment on patients’ nutritional status and overall health. By comparing the two groups, researchers hope to find the most effective way to support patients’ nutritional needs and improve their quality of life during and after cancer treatment.

1 randomization

Upon joining the study, you will be randomly assigned to one of two groups: the prophylactic PEG tube group or the reactive PEG tube group. This assignment is done by chance, like flipping a coin, to ensure fairness in the study.

2 treatment initiation

You will begin treatment for advanced head and neck cancer. This includes chemotherapy and radiotherapy. The chemotherapy involves receiving cisplatin through an intravenous (IV) line. The exact dosage and frequency will be determined by your healthcare provider based on your specific needs.

3 imaging and diagnostic tests

During the treatment, you will undergo various imaging tests such as DECT and PET-CT to monitor the response of the tumor to the treatment. These tests help in assessing the effectiveness of the therapy.

4 questionnaire completion

You will be asked to complete several questionnaires to report your experiences and quality of life. These include the MD Anderson Dysphagia Inventory (MDADI), HRQOL questionnaires, and others related to oral and salivary health. These questionnaires help in understanding the impact of the treatment on your daily life.

5 adverse event monitoring

Throughout the study, any side effects or adverse events you experience will be closely monitored. This includes any reactions to the treatment, which will be recorded and assessed according to established criteria.

6 end of treatment assessment

At the end of the treatment, your overall health and the status of the cancer will be evaluated. This includes checking for loco-regional control, distant recurrence, and other outcomes related to the cancer.

7 follow-up

You will continue to be monitored for a period after the treatment to assess long-term outcomes and any late side effects. This follow-up is crucial for understanding the full impact of the treatment on your health.

Who Can Join the Study?

Must be at least 18 years old.
Women who can have children must agree to use a highly effective method of birth control before starting the study, during the study, and for at least 6 months after the last dose of the medication called cisplatin.
Men with partners who can have children must agree to use a condom during the study and for at least 6 months after the last dose of cisplatin.
Must have adequate bone marrow function, which means:
- Enough white blood cells (called neutrophils) to fight infections.
- Enough hemoglobin in the blood, which carries oxygen.
- Enough platelets to help the blood clot.
Must have adequate liver function, which means:
- Normal levels of bilirubin, a substance made by the liver.
- Normal levels of liver enzymes called AST and ALT.
- Normal levels of alkaline phosphatase, another liver enzyme.
Must have adequate kidney function, which means:
- Normal levels of creatinine, a waste product filtered by the kidneys.
- Good creatinine clearance, which measures how well the kidneys are working.
Must have peripheral neuropathy (nerve damage) that is mild (grade 1 or less).
Must have hearing impairment that is mild (grade 1 or less).
Must complete all necessary screening tests within 15 days before being randomly assigned to a group in the study.
Must sign an Informed Consent Form before any study-related procedures.
Must be able to understand and complete questionnaires, as judged by the study doctor.
Must have an ECOG performance status of 2 or less, which measures daily living abilities.
Both females and males can participate.
Must have a newly diagnosed, confirmed type of cancer called squamous cell carcinoma in specific areas like the mouth, throat, or voice box.
Must be a candidate for treatment aimed at curing the cancer, including radiation and medication.
Must not have had any previous or current cancer treatment for head and neck cancer, such as chemotherapy or surgery.
Must have biopsy results available at the time of screening.
Must have results of HPV/p16 testing available for throat cancer at the time of screening.
Women who can have children must have a negative pregnancy test within 7 days before the first treatment.

Who Cannot Join the Study?

Patients who do not have oropharyngeal cancer cannot participate. Oropharyngeal cancer is a type of cancer that occurs in the part of the throat called the oropharynx.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Institut Jules Bordet	Anderlecht	Belgium
CHU Saint Pierre	Brussels	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	02.08.2021

Trial locations

Investigated drugs:

Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. It works by stopping or slowing the growth of cancer cells, which grow and divide quickly. In this trial, chemotherapy is used as part of the treatment for advanced head and neck cancer. The goal is to help shrink the tumor and make it easier to treat with other therapies, like radiation.

Radiotherapy, also known as radiation therapy, is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, radiotherapy is used alongside chemotherapy to treat advanced head and neck cancer. The radiation targets the cancer cells in the head and neck area, aiming to destroy them while minimizing damage to surrounding healthy tissue.

Percutaneous Endoscopic Gastrostomy (PEG) Tube is a procedure where a tube is placed into the stomach through the abdominal wall. This tube allows for direct feeding into the stomach, which can be necessary for patients who have difficulty swallowing due to their cancer or its treatment. In this trial, the PEG tube is used either before (prophylactic) or after (reactive) the start of chemo-radiotherapy to help maintain nutrition and improve quality of life for patients with advanced head and neck cancer.

Investigated diseases:

Oropharyngeal cancer

Oropharyngeal Cancer – Oropharyngeal cancer is a type of cancer that occurs in the oropharynx, which is the middle part of the throat. It typically begins in the cells lining the throat and can affect areas such as the back of the tongue, the soft palate, the tonsils, and the walls of the pharynx. The disease often starts as a small, painless growth or sore that does not heal. As it progresses, it may cause symptoms like difficulty swallowing, a persistent sore throat, or changes in voice. The cancer can spread to nearby tissues and lymph nodes, and in advanced stages, it may affect other parts of the body. The progression of oropharyngeal cancer can vary, with some cases growing slowly while others may advance more rapidly.

Trial ID:

2023-506258-19-00

Protocol code:

IJB-RT-HNC-001

NCT ID:

NCT04019548

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Swallowing and Quality of Life in Advanced Head and Neck Cancer Patients Using Cisplatin and Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?