Mucositis Clinical Trial
Official title:
A Randomized, Double-Blind Pilot Study of N-Acetylcysteine Mucoadherent Rinse Versus Placebo for Thickened Secretions and Mucositis Secondary to Chemoradiotherapy in the Management of Head and Neck Malignancies
This randomized pilot clinical trial studies whether acetylcysteine oral rinse will lessen saliva thickness and painful mouth sores in patients with head and neck cancer undergoing radiation therapy. Side effects from radiation therapy to the head and neck, such as thickened saliva and mouth sores, may interfere with activities of daily living such as eating and drinking, and may also cause treatment to be stopped or delayed. Acetylcysteine rinse may reduce saliva thickness and mouth sores, and improve quality of life in patients with head and neck cancer undergoing radiation therapy.
PRIMARY OBJECTIVES:
I. To determine the effectiveness of N-acetylcysteine (acetylcysteine) in improving saliva
viscosity (as measured by the Groningen Radiotherapy-Induced Xerostomia [GRIX]) in patients
undergoing chemotherapy and radiotherapy for head and neck cancer.
SECONDARY OBJECTIVES:
I. To determine whether N-acetylcysteine (NAC) can improve other GRIX subscale for patients
undergoing chemotherapy and radiotherapy for head and neck cancer.
II. To determine whether NAC can improve patient reported quality of life as measured by the
European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life
Questionnaire (QLQ) Head & Neck (H&N)35.
III. To assess the adverse event profile of NAC as measured by the Common Terminology
Criteria for Adverse Events (CTCAE) every week during radiation.
IV. To determine patient adherence to N-acetylcysteine mucoadherent rinse using patient
reported surveys.
V. To determine the long-term benefits of N-acetylcysteine as measured by the GRIX
questionnaire at 45 days and 90 days post treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then
spit 5 times per day, beginning within 3 days of the initiation of radiotherapy to 14 days
following completion of radiotherapy.
ARM II: Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then
spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days
following completion of radiotherapy.
After completion of study treatment, patients are followed up at 45 and 90 days.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02252926 -
Local Anesthetic Treatment of Oral Pain in Patients With Mucositis
|
Phase 2 | |
| Completed |
NCT01155609 -
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
|
N/A | |
| Completed |
NCT00357942 -
Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy
|
Phase 4 | |
| Completed |
NCT00360685 -
Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX
|
N/A | |
| Completed |
NCT04586491 -
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
|
N/A | |
| Withdrawn |
NCT02589860 -
Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
|
||
| Not yet recruiting |
NCT02506231 -
The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome
|
Phase 2/Phase 3 | |
| Completed |
NCT02605382 -
Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis
|
Phase 2 | |
| Completed |
NCT02639377 -
Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis
|
Phase 2 | |
| Terminated |
NCT02575313 -
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00956254 -
Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis
|
Phase 3 | |
| Completed |
NCT00584597 -
A Trial of Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis
|
Phase 1 | |
| Enrolling by invitation |
NCT05590117 -
Protective Effect of Pentoxifylline Against Chemotherapy Induced Toxicities in Patients With Colorectal Cancer
|
Early Phase 1 | |
| Completed |
NCT05635929 -
Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.
|
N/A | |
| Completed |
NCT05181943 -
Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis
|
N/A | |
| Completed |
NCT03713567 -
Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis
|
N/A | |
| Completed |
NCT02671812 -
Outcome After Dental Implant Treatment
|
||
| Terminated |
NCT02273752 -
Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer
|
Phase 2 | |
| Recruiting |
NCT01707641 -
Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer
|
Phase 4 | |
| Completed |
NCT01015183 -
Prevention Chemotherapy Induced Mucositis by Zinc Sulfate
|
Phase 2/Phase 3 |