Argenta, P.A., Ballman, K.V., Geller, M.A., Carson, L.F., Ghebre, R., Mullany, S.A., . . . Erickson, B.K. (2017). The effect of photobiomodulation on chemotherapy-induced peripheral neuropathy: A randomized, sham-controlled clinical trial. Gynecologic Oncology, 144, 159–166.

Investigate whether photobiomodulation (PBM) reduced peripheral neuropathy symptoms in patients with CIPN and determine if the addition of physical therapy to PBM would improve results.

Treatments of PBM, administered three times per week for six weeks, 30 minutes per visit, with treatments administered via handheld wand at a distance of 1 cm from the skin for 1-12 minutes over any of the up to 36 specified areas on the body. The sham group were exposed to a laser which generates a sense of warmth. The PBM+PT group received PBM plus physiotherapy of manual soft tissue mobilization at each treatment visit for 15 minutes along with instructions for home stretches to be performed twice daily.

• N = 70   
• AGE: No mean age noted in the study; largest percentage of participants were aged 61-70 years (45.7%)
• FEMALES (%): 100
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Sample is primarily patients with breast or gynecologic cancer treated with chemotherapy not within the last 30 days
• OTHER KEY SAMPLE CHARACTERISTICS: Primarily Caucasian

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: University of Minnesota

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care

Prospective, double-blind, randomized, sham-controlled

Data collected via modified total neuropathy score (mTNS) to measure change in overall score from baseline, 4, 8, and 16 weeks.

PBM group had statistically significant improvement in mTNS score (-6.8 points; -52.6%) from pretreatment to eight weeks after initiation of treatment (p < 0.001). Sham group had no evidence of improvement in mTNS score. Thirty-eight of the sham group patients crossed over to the PBM+PT group. This group experienced a significant improvement (-6.9 points; -50.9%) in mTNS score (p < 0.001) from baseline. The difference in mean mTNS reductions between PBM and PBM+PT was 0.1 (p = 0.85), indicating the addition of PT to PBM did not improve neuropathy symptoms more than PBM alone. Both the PBM and PBM+PT group experienced modest regression in mTNS scores by week 16. Only one complication was observed with one patient experiencing a second-degree burn in the sham control group. There were no complications noted in patients receiving PBM.

PBM was shown to be an effective intervention for CIPN, with 90% of patients experiencing significant improvement in mTNS scores. This is a positive result in the sample population. There was a high compliance rate and low dropout rate in this study, contributing to the validity of the findings. Long-term benefits beyond 16 weeks are not known.

• Small sample (< 100)
• Risk of bias (sample characteristics): all females, primarily breast/gynecologic cancers, primarily Caucasian
• Other limitations/explanation: Impact of other concurrent treatments for CIPN were not considered; optimization of treatment algorithm. Treatment must be administered by a certified laser technician, which may not be available in all settings.

Need for further research on this intervention and awareness of nonpharmacologic interventions which may impact neuropathy symptoms.