Evaluating swallowing function and quality of life in patients with oropharyngeal cancer after treatment
Patient Reported Outcomes in Term of Swallowing and Quality of Life After Prophylactic Versus Reactive Percutaneous Endoscopic Gastrostomy Tube Placement in Advanced Oropharyngeal Cancer Patients Treated With Definitive Chemo-radiotherapy
This study tests whether placing a feeding tube before or after treatment helps people with oropharyngeal cancer swallow better and improves their quality of life during chemoradiotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jules Bordet Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Brussels and 1 other locations) |
| Trial ID | NCT04019548 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial investigates the swallowing function and quality of life in patients diagnosed with oropharyngeal cancer who are undergoing chemoradiotherapy. Participants are randomly assigned to receive either prophylactic or reactive placement of a percutaneous endoscopic gastrostomy (PEG) tube to support nutrition during treatment. All subjects will receive a standard cisplatin chemotherapy regimen alongside intensity-modulated radiotherapy. The study aims to assess the impact of these interventions on patients' swallowing abilities and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx who are eligible for curative treatment.
Not a fit: Patients with prior anticancer treatments or those not diagnosed with oropharyngeal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve nutritional support and quality of life for patients undergoing treatment for oropharyngeal cancer.
How similar studies have performed: Other studies have shown success with similar approaches in managing nutritional support during cancer treatment, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age ≥ 18 years old
2. ECOG performance status ≤ 2
3. Female and Male
4. Newly diagnosed, histologically confirmed primary squamous cell carcinoma of the oropharynx
5. Candidate for curative intent radiotherapy and systemic treatment
6. No prior or current anticancer treatment for the HNSCC (e.g. neo-adjuvant chemotherapy, surgery)
7. Diagnosis biopsy results
8. HPV/p 16 testing results
9. Serum test (for subjects of childbearing potential) negative within 7 days prior to the 1st CRT administration.
10. Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 6 months after the last administration of cisplatin.
11. Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the cisplatin.
12. Adequate bone marrow function as defined below:
* Absolute neutrophil count (ANC) ≥1500/µL or 1.5x109/L
* Hemoglobin ≥ 9 g/dL
* Platelets ≥100000/µL or 100x109/L
13. Adequate liver function as defined below:
* Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome \< 3 x UNL is allowed
* AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN
* Alkaline phosphatase ≤ 2.5 x ULN
14. Adequate renal function as defined below:
* Creatinine ≤ 1.5 x UNL and creatinine clearance \> 60 mL/min
15. Peripheral neuropathy ≤ grade 1
16. Hear impaired ≤ grade 1
17. Completion of all necessary screening procedures within 15 days prior to randomisation.
18. Signed Informed Consent form (ICF) obtained prior to any study related procedure.
19. Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by principal investigator upon screening
Exclusion Criteria:
1. Severe malnutrition
2. Dysphagia requiring a liquid or puree texture modified diet (grade ≥ 2 (CTCAE\_v.5)
3. Distant metastasis
4. Serious coagulation disorders (INR\>1.5, PTT\>50s, platelets \<50000/mm3)
5. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
6. Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin;
7. Pregnant and/or lactating women.
8. Known hypersensitivity to the study drug (cisplatin) or excipients.
Where this trial is running
Brussels and 1 other locations
- CHU Saint Pierre — Brussels, Belgium (Not_yet_recruiting)
- Institut Jules Bordet — Brussels, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.