Clinical trial · Interventional
Laser InGaAlP (660Nm) to Prevent Radiodermatitis in Breast Cancer Patients Submitted to Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast neoplasm is the second most common type in the world. Radiation therapy is a key component in the treatment of breast cancer. Acute skin reaction is one of the most common side effects of radiation therapy. Several studies were performed for prophylaxis of this adverse event, however, until this moment there is no consensus for clinical practice . Second meta-analysis , the ideal candidate for the radiodermatitis prevention would be an agent capable of repairing damage to DNA or agents that promote cell proliferation . The low power laser promotes tissue repair ( reduces inflammatory phase and induces collagen synthesis ) . Its use in the treatment of adverse events of cancer treatment is well established in two situations : in the prophylaxis and treatment of mucositis and in the treatment of lymphedema . The purpose of this study is to use the low power laser in patients with breast cancer undergoing radiotherapy treatment to evaluate the effects of Laser InGaAIP 660Nm in preventing radiodermatitis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Radiotherapy; Adverse Effect, Dermatitis or Eczema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser therapy | Device | — | UNRESOLVED |
| Placebo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- In the control group, 26 patients will be submitted to a laser, but the laser will be disabled without affecting its apparent function , five days a week before radiotherapy . Both arm will use institutional skin care protocol.
- interventionNames
- Device: Placebo
- type
- EXPERIMENTAL
- label
- Laser therapy
- description
- In the intervention group, 26 patients will be submitted a laser therapy .The low level laser therapy used in this trial will be Photon Lase III (DMC, approved by ANVISA for medicinal purposes). This InGaAIP laser emits a pulsed 660 nanometer beam with an average output of 80 milliwatts and the average energy density delivered to the breast will be 3 J/cm2. It will be administrated five days a week before radiotherapy. Both arm will use institutional skin care protocol.
- interventionNames
- Device: Laser therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age at least 18 years, female gender only. 2. Patients with histological diagnosis of breast cancer (invasive ductal carcinoma, invasive lobular and other types), stages I-III 3. Patients who underwent breast-conserving surgery or mastectomy without breast reconstruction 4. Patients undergoing to adjuvant radiotherapy with conventional dose according to Barretos Cancer's Hospital protocol 5. Patients in the radiotherapy planning , presenting : * In the central court : " Hot Spot " ( ICRU ) ≤ 107 % * At full volume : " Hot Spot " ( ICRU ) ≤ 110 % Exclusion Criteria: * Patients undergoing mastectomy with immediate breast reconstruction * Patients without histological diagnosis of breast cancer * Patients with indication for radiotherapy without conventional dose * Patient with indication for treatment in supraclavicular fossa * Patients suffering from collagen * Patients who do not meet the criteria for planning radiotherapy
References
Publications (1)
- DERIVEDCosta MM, Silva SB, Quinto AL, Pasquinelli PF, de Queiroz dos Santos V, de Cassia Santos G, Veiga DF. Phototherapy 660 nm for the prevention of radiodermatitis in breast cancer patients receiving radiation therapy: study protocol for a randomized controlled trial. Trials. 2014 Aug 20;15:330. doi: 10.1186/1745-6215-15-330. PMID 25141962