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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 12/27/2010

Regular Sunscreen Use May Reduce Invasive Melanoma Risk

Adapted from the NCI Cancer Bulletin 1.

Regular sunscreen use may reduce the risk of developing melanoma 2, according to results 3 of a randomized controlled trial that were reported December 6, 2010, in the Journal of Clinical Oncology. The trial is the first prospective, randomized study to investigate the link between sunscreen use and melanoma, the most deadly type of skin cancer.

Researchers led by Adèle Green, Ph.D., of the Queensland Institute of Medical Research examined the incidence of melanoma among 1,621 white adults in a township in Queensland, Australia. They divided the study participants, age 20 to 69, into two groups. From 1992 to 1996, the participants in one group were given an unlimited supply of a broad-spectrum sunscreen with a sun protection factor (SPF) of 16 and were asked to apply it every morning to their head, neck, arms, and hands, and reapply it after heavy sweating, bathing, or long sun exposure. The control group continued using sunscreen of any SPF at their usual discretionary frequency, which for some included no use.

Dr. Green and her colleagues followed the study participants for 10 additional years and tracked all cases of primary melanoma newly diagnosed between 1993 and 2006. They found 11 new cases of melanoma in the daily sunscreen group compared with 22 cases in the discretionary sunscreen group, a 50 percent reduction. Invasive melanoma was reduced by 73 percent in the daily sunscreen group compared with the control group (3 versus 11 cases).

The authors noted that their results are of borderline statistical significance and suggested that their findings for invasive melanoma in particular “should be interpreted cautiously.” Nevertheless, they concluded, “among adults age 25 to 75 years, regular application of SPF 15+ sunscreen in a 5-year period appeared to reduce the incidence of new primary melanomas for up to 10 years.”

In an accompanying editorial 4, Phyllis Gimotty, Ph.D., and Karen Glanz, Ph.D., of the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania School of Medicine wrote: “To our knowledge, the trial’s findings are the first to provide strong evidence for a reduction in the incidence of invasive melanoma after regular application of broad-spectrum sunscreen in adults…. It is unlikely that another trial of comparable scope and rigor will be conducted in the foreseeable future.”

Furthermore, they wrote, although “the question of its efficacy with respect to melanoma prevention should no longer deter scientists or clinicians from recommending sunscreen use,” effective skin cancer prevention should also include avoiding exposure to ultraviolet rays, using clothing to shield skin from the sun, and performing regular skin self examinations.

“This study provides important evidence regarding the role of sunscreen use as part of a range of sun-protective behaviors that effectively reduce risk of melanoma,” commented Margaret Tucker, M.D., of NCI’s Division of Cancer Epidemiology and Genetics 5

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Glossary Terms

control group (kun-TROLE groop)
In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works.
invasive cancer (in-VAY-siv KAN-ser)
Cancer that has spread beyond the layer of tissue in which it developed and is growing into surrounding, healthy tissues. Also called infiltrating cancer.
randomized clinical trial (RAN-duh-mized KLIH-nih-kul TRY-ul)
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
statistically significant (stuh-TIS-tih-kuh-lee sig-NIH-fih-kunt)
Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.
sun protection factor (... proh-TEK-shun FAK-ter)
A scale for rating the level of sunburn protection in sunscreen products. The higher the sun protection factor, the more sunburn protection it gives. Sunscreens with a value of 2 through 11 give minimal protection against sunburns. Sunscreens with a value of 12 through 29 give moderate protection. Sun protection factors of 30 or higher give high protection against sunburn. Also called SPF.

Table of Links

1http://www.cancer.gov/ncicancerbulletin
2http://www.cancer.gov/cancertopics/types/melanoma
3http://www.ncbi.nlm.nih.gov/pubmed/21135266
4http://www.ncbi.nlm.nih.gov/pubmed/21135278
5http://dceg.cancer.gov
6http://www.cancer.gov/clinicaltrials/search