Staph Nasal Decolonization to Improve Function and Feeding

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Palma

About this trial

Radiation therapy is a type of treatment that involves using radiation beams targeted at a cancer to destroy the cancer cells or slow their growth. This type of treatment has helped many cancer patients for decades and is intended to kill cancer cells directly. Patients with head and neck cancer are commonly treated with radiation, sometimes after surgery and sometimes the radiation is delivered with chemotherapy at the same time. Radiation treatments have side effects, and the treating oncologist works with each patient to determine the best treatment and manage the side effects.

It has been shown that one of these side effects of radiation is irritation or "sunburn" of the lining of the mouth and throat (radiation mucositis), which can cause difficult or painful swallowing, and pain/discomfort in the mouth/throat. These side effects can lead to dehydration, and weight loss, and sometimes can lead to hospital admissions and treatment delays. This is usually treated by the prescription of pain relievers, dietician support and, if necessary, nutrition via a tube (G-tube).

Because of these symptoms involving the mouth and throat, researchers are looking to study the effect of a common ointment antibiotic used to reduce an infection known as Staphylococcus Aureus. The infection is commonly located in the front of the nose, and during treatment this infection can travel from the nose to the throat and worsen the radiation mucositis and the pain it causes. The study will measure if a course of ointment antibiotic in the nose (twice per day, 5 days on, 5 days off, repeated) can reduce your pain during treatment by reducing severe mucositis related to Staphylococcal infection. This study compares the effects of the study treatment with a "placebo," which looks the same but does not contain any active medicine. Neither you nor your doctor will know which one you are receiving until the study ends. The antibiotic used in the study arm is being used "off-label" for intranasal application (it is normally used to treat skin infections). Possible side effects include local skin irritation or allergic reactions, and in rare cases, a severe allergic response (anaphylaxis).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed mucosal squamous cell carcinoma of the head and neck, planned to receive a dose equivalent to 60 Gy in 30 fractions or higher, with or without concurrent systemic treatment. This can include hypofractionated regimens of 55 Gy in 20 fractions. Primary sites considered: oral cavity, oropharynx, larynx (excluding T1-T2N0 glottic cancers), hypopharynx. The radiotherapy treatment planned can be definitive or adjuvant.

Age ≥18 years.

ECOG performance status 0-2

Informed consent provided.

Disqualifiers

Mupirocin allergy

Skin or salivary gland malignancy

Early stage glottic cancers (T1-2N0)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mupirocin Ointment [Treatment]

    Drug

    1 fingertip unit of topical mupirocin ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment

  • Placebo

    Drug

    1 fingertip unit of topical petrolatum ointment (placebo) applied BID to both nares in cyclical week on/off fashion throughout radiation treatment

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Mupirocin topical ointmentExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient reported pain (Numeric rating scale (NRS) 0-10, validated 11-point tool for assessing pain intensity, ranging from 0 (no pain) to 10 (worst imaginable pain))

Severity of pain in mouth or throat, measured on a 0-10 pain scale. Assessed weekly during treatment, using worst noted pain across treatment duration for analysis

Time frame
Measured weekly for duration of radiation treatment (Maximum 7 weeks)

Secondary outcomes

1

Oral mucositis grade (Radiation Therapy Oncology Group scale 1-4 (Grade 1 (erythema/mild pain) to Grade 4 (severe necrosis/deep ulcerations requiring support))

The RTOG (Radiation Therapy Oncology Group) mucositis grading scale evaluates radiation-induced oral mucositis severity in four stages. It ranges from Grade 1 (erythema/mild pain) to Grade 4 (severe necrosis/deep ulcerations requiring support). This will be measured weekly by physician/nurse specialist

Time frame
Weekly for duration of radiation (Max 7 weeks)
2

Quality of life score

The MDASI-HN (M. D. Anderson Symptom Inventory-Head and Neck) is a 28-item, patient-reported tool measuring symptom severity (0-10 scale) and daily life interference for head and neck cancer patients. It covers 13 core symptoms, 9 head/neck-specific items (e.g., dry mouth, swallowing), and 6 interference items . 0-10 Scale: Each item is rated from 0 ("not present") to 10 ("as bad as you can imagine"). The maximum total score for the 28 items is 280, with a specific focus on 9 Head \& Neck items (maximum 90).The score will be measured at treatment start and in final week of treatment

Time frame
Measured at treatment start and in final week of treatment (Max 7 weeks)
3

Treatment interruptions

Any treatment interruptions measured at weekly assessment

Time frame
Any treatment interruptions measured at weekly assessment (Max 7 weeks)
4

Feeding tube insertion

Any feeding tube insertion measured at weekly assessment

Time frame
Any feeding tube insertion measured at weekly assessment (Max 7 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Palma

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: