Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04059809 |
| Other study ID # |
2.777.676 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
September 26, 2018 |
| Est. completion date |
July 20, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
AC Camargo Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A prospective single blind controlled randomized trial to evaluate the superiority of
photobiomodulation (PBM) using LED-therapy in reducing the prevalence of radiodermatitis in
breast cancer compared to usual local care.
Description:
Breast cancer is the second most common cancer in the world, the most common among women in
Brazil and accounts for approximately 25% of new cases of cancer in women. One of the pillars
of treatment is the radiotherapy, being able to generate a toxic effect in the neoplastic
cells and also deleterious in healthy cells, with early and late side effects, being
radiodermatitis one of these affections. Moreover, radiodermatitis may cause discontinuation
of radiotherapy until the skin is able to receive the appropriate dose. Photobiomodulation
(PBM) is a non-invasive, a-thermal treatment modality based on the effect of light in
biological systems leading to the activation of epithelial healing through the modulation of
several metabolic processes through photochemical reactions. PBM use in an oncologic setting
has become an interesting object of study in recent years and even though there are different
possibilities for the use in breast cancer and physicians are not yet familiar with this
therapy. Several in vitro studies with different cell types ranging from keratinocytes,
endothelial cells and fibroblasts have been performed showing that PBM is capable of
enhancing cell migration, proliferation, local metabolism, inducing collagen synthesis and
secretion of growth factors, self-regulation of the production of proinflammatory cytokines
and cellular apoptosis, aiding in the recovery of the dermis and epidermis. The aim of this
study will be to evaluate the superiority of the use of photobiomodulation using LED-therapy
in relation to the development of radiodermatitis in breast cancer compared to usual local
care.
The study will included 110 women after informed consent will be randomly assigned into two
groups. There will be 11 groups of 10 envelopes each, where each group will contain a code
that allocates patients in group A (05 patients) and group B (05 patients). After the
allocation of the 10 patients, a new envelope group will be available until the total number
of patients scheduled for this study is reached (110, 55 in each group). Group A (GA) will be
the control group of usual care according to the orientation of the radiation therapy clinic
responsible for the radiotherapy treatment and with the use of the PBM device switched off.
Group B (GB) will be the intervention group, which in addition to the usual care oriented in
the radiotherapy clinic responsible for the radiotherapy treatment will use the attached PBM.
Both groups will use a pair of glasses that will block the visualization of the light emitted
by the PBM device, precisely so that they do not know in which research group it is located.
Treatment will be done twice weekly, Tuesday and Thursday. The Photobiomodulation will be
with the Cicatrillux (Cosmedical®) LED that contains 36 red light emitters in a 10x12 cm
neoprene plate with 650 nm LED wave length whose optical spot diameter is 5 mm and with an
average wave length of 2 ~ 5 mw for 10 minutes that will be placed over the area that will be
irradiated for 10 minutes; the LED board will be wrapped in a plastic film that will be
changed between each use. Both, the control group and the intervention group, will be
evaluated for radiodermatitis by the oncologist who accompanies them and by a nurse, and both
evaluators will not know in which group the person evaluated belongs. Concomitant to the
radiotherapy sessions, both groups will be evaluated by a clinical and sociodemographic
questionnaire, by the "Behavioral Risk Factor Surveillance System" (BRFSS), by the
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) by the Analog Visual Scale
for Pain, Radiodermatitis Assessment through the Radiation Therapy Oncology Group (RTOG),
application of the European Organization for Research and Treatment of Breast Cancer-Specific
Quality of Life Questionnaire questionnaire (EORTC QLQ-BR23) and the European Organization
for Research and Treatment of Cancer (EORTC QLQ-30), all questionnaires have already been
translated and validated into the Portuguese language. The classification of radiodermatitis
and pain assessment will be repeated 90 days after the start of radiotherapy. A descriptive
and comparative analysis of the intervention groups will be performed in relation to the
selected variables. The evaluation of the outcomes will be performed by intention to treat
and by adherence to the protocol, through relative risk, and 95% confidence interval. To
analyze the data will be used "Statistical Package for Social Sciences" (SPSS) v.23 Demo
(SPSS Inc., Chicago, Illinois, United States). The McNemar test will be used to compare pain
levels between groups. For inter-group assessments of the proportion of radiodermatitis, the
chi-square test will be used to compare the intervention and control of the group.
Secondary objectives will be to describe the socio-demographic and clinical characteristics
of the studied population; to evaluate the incidence of radiodermatitis in people with breast
cancer, immediately after and 90 days post-radiotherapy according to study intervention
group; to evaluate the adherence and satisfaction to treatment with PMB using LED-therapy in
people with breast cancer; to compare the occurrence of pain and its graduation according to
the intervention group, immediately after the radiotherapy and in the follow-up of 90 days in
people with breast cancer; to evaluate the quality of life of people submitted to
radiotherapy for breast cancer according to the intervention group and changes in
radiotherapy treatment.
The inclusion criteria are women older than 18 years with histological diagnosis of breast
cancer who underwent conservative surgery or mastectomy, without immediate breast
reconstruction, treated with conventional radiotherapy referred by the oncologist who
accompanies her regularly and who have availability of 20 minutes before the radiotherapy
session to CORSB Radiation Therapy and Megavoltage to apply the LED-therapy and accept to
participate in the research signing the Free and Informed Consent Term (TCLE). Patients who
have undergone mastectomy with immediate breast reconstruction and those who suffer from
collagen diseases will be excluded from this study.
The investigators hypothesized that photobiomodulation can stop the progression of
radiodermatitis or lead to a faster cure, in turn, would have beneficial effects on the
quality of life of these people. Then, it is expected that, at the end of radiotherapy
sessions, people treated with therapy would have less severe skin reactions and higher
quality of life when compared to people in the control group.
