Bensadoun RJ et al. - Photobiomodulation and Radiation-Induced Mucositis in Head and Neck Cancers: A Phase III Randomized Trial

In 30 patients who underwent radiation therapy for head and neck cancer, the use of a helium-neon laser prior to each radiation therapy session reduced the incidence of severe mucositis and severe pain. This Phase III trial, published in 1999, is the first rigorous randomized trial conducted in the field of photobiomodulation.

What this publication measured

Oral mucositis is one of the most feared complications of radiation therapy for head and neck cancers. Between September 1994 and March 1998, a French team based in Nice randomized 30 patients in a multicenter, double-blind, phase III trial. The device tested was a low-energy helium-neon laser with a wavelength of 632.8 nm and a power of 60 mW, which was reduced to 25 mW for one patient treated in Reims. Participants had carcinoma of the oropharynx, hypopharynx, or oral cavity and received radiotherapy alone at a total dose of 65 Gy, administered at 2 Gy per fraction and 5 fractions per week, without prior surgery or concomitant chemotherapy. The tumor had to be located outside the nine laser application points. Treatment—either active laser or placebo light—began on the first day of radiation therapy, prior to each session. A blinded physician assessed mucositis weekly using the WHO scale and evaluated pain on a segmented visual analog scale. Photobiomodulation was used here as supportive care to mitigate an adverse effect of the treatment, not as a cancer treatment.

Key Findings

The authors rated the protocol's feasibility and compliance as excellent.

• Mucite de grade 3 : 35,2 % sans laser contre 7,6 % avec laser (p < 0,01)
• Douleur sévère de grade 3 : 23,8 % sans laser contre 1,9 % avec laser (p < 0,05)
• Significant pain relief throughout the treatment period, from weeks 2 through 7
• Randomized sample size: 30 patients, recruited from September 1994 to March 1998

The authors conclude that this laser is capable of reducing the severity and duration of oral mucositis associated with radiation therapy. The abstract does not report any confidence intervals.

How photobiomodulation works for this indication

The authors describe laser irradiation as the local application of a monochromatic light source with high photon density. The most widely recognized effect at the time was the promotion of epithelial healing of the treated surfaces, as confirmed by numerous in vitro studies. The text notes that the mechanism of action at the molecular and enzymatic levels was still under investigation at that time. The trial demonstrates a clinical effect; it does not demonstrate the mechanism that produces it.

Limits You Should Know

The first point concerns the sample size: 30 randomized patients is a small number, and the reported percentages are based on repeated weekly assessments. The second point is the age of the publication. This trial is twenty-seven years old. The devices, available wavelengths, power levels, and dosimetry parameters have evolved significantly since then, as have the radiation therapy techniques themselves. The figures obtained with a 60 mW helium-neon laser in 1999 cannot be automatically applied to current protocols and equipment. Finally, the trial excluded patients receiving concomitant chemotherapy, a situation that is common today.

What This Means in Practice

The significance of this publication is primarily historical. It provided the first randomized, double-blind demonstration of the clinical benefit of photobiomodulation. It paved the way for research that, about fifteen years later, led to the inclusion of photobiomodulation in international guidelines for supportive care in oncology. From a practical standpoint, it serves as a reminder that the indication pertains to the prevention of an adverse treatment effect, and that this decision rests with the oncology team caring for the patient.

Frequently Asked Questions

Does photobiomodulation prevent mucositis during ENT radiation therapy?

In this trial, she did not eliminate it, but the proportion of grade 3 mucositis decreased from 35.2% to 7.6%. This represents a reduction in severity observed in 30 patients, not a guarantee of prevention.

Why is this 1999 essay still cited?

Because it is the first rigorous randomized, double-blind trial conducted in the field of photobiomodulation. However, its technical parameters are now outdated.

Who decides whether to use photobiomodulation during cancer treatment?

The oncology team treating the patient. Photobiomodulation is considered supportive care in this context, and its use should be discussed with the physicians responsible for the patient’s treatment.

Reference

Bensadoun RJ, Franquin JC, Ciais G, et al. Low-energy He/Ne laser for the prevention of radiation-induced mucositis. A multicenter phase III randomized study in patients with head and neck cancer. Supportive Care in Cancer, 1999. PMID 10423050. View the study on PubMed

This summary is provided for informational purposes only and does not constitute medical advice. Photobiomodulation is not a substitute for prescribed treatment. Consult a healthcare professional.