Could a laser beam stop chemo mouth sores?
NCT ID NCT01772706
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This trial investigates whether a low-level diode laser can prevent or reduce severe mouth sores (mucositis) caused by radiation and chemotherapy in people with advanced head and neck cancer. Participants receive either real laser therapy or a non-functional placebo laser during their cancer treatment. The study measures how many patients develop painful mouth sores that affect eating, aiming to find a simple way to ease a common side effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-level diode laser therapy
- What this could lead to
- If effective, this laser treatment could become a standard way to prevent painful mouth sores during cancer therapy, improving patients' quality of life.
- What could go wrong
- This is a mid-stage trial with 97 participants, so results may not apply to all patients. The laser may not reduce severe mucositis more than a placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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97 people
The number who actually took part.
- Started
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Oct 2008
- Finished
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Mar 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 18 and 75 years 2. Patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage III-IV, histologically confirmed 3. PS \> or = 2 4. Estimated life expectancy greater than 3 months in the absence of treatment 5. Concomitant chemotherapy with one of the following choices not prohibited: * Cetuximab alone * 5-FU combined to Carboplatin or Cisplatin * Cisplatin alone Being defined as follows: serum creatinine \< 150 µmol/l and creatinine clearance superior or equal to 55ml/min (calculated with the Cockcroft method) in case of serum creatinine \> 120 µmol/l 6. Appropriate hematological, renal and hepatic function parameters, within 15 days prior to randomization, with the following results: * Hemoglobin\> 8g/dL * Neutrophils\> 1500 x 109 / L * Platelets\> 100 x 109 / l * Total bilirubin \<1.5 times the upper limit of normal * ALT / AST and alkaline phosphatase \<2.5 times the upper limit of normal. 7. For women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required. Exclusion Criteria: 1. Presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix 2. Neoadjuvant chemotherapy 3. Metastatic disease 4. Previous treatment with ENT radiotherapy 5. Severe hypersensitivity known to platinum based agent 6. Any uncontrolled pathology (respiratory, cardiac, hepatic or renal) 7. Pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Guillaume le Conquérant
Le Havre, 76600, France
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Centre Jean Godinot
Reims, 51100, France
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Centre hospitalier universitaire La Milétrie
Poitiers, 86021, France
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Clinique Armoricaine de Radiologie
Saint-Brieuc, 22015, France
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Hôpital La Pitié Salpêtrière
Paris, 75013, France
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Institut de Cancerologie de l'Ouest Paul Papin
Angers, 49933, France
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Other studies related to the condition(s) this trial covers.
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- Aloe vera mouthwash tested against chemotherapy mouth sores
- Can planned IV fluids tame the brutal side effects of head and neck cancer treatment?