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临床试验/NCT05663723
NCT05663723已完成不适用

Photobiomodulation for Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer

Erica Alves Nogueira Fabro2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2023年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
186
试验地点
2
主要终点
Peripheral neuropathy

研究概览

简要总结

Double-blind Superiority Randomized Controlled Clinical Trial. Objective of the study: To evaluate the effectiveness of photobiomodulation using the LED board in the prevention of peripheral neuropathy in the lower limbs in women with breast cancer undergoing chemotherapy at the Cancer Hospital III of the National Cancer Institute (HCIII/INCA).

详细描述

Materials and methods

This is a single-blind superiority randomized controlled clinical trial. Women aged over 18 years, with breast cancer in stages I to IIIC and who have an indication for curative treatment with neoadjuvant or adjuvant chemotherapy at HCIII/INCA will be eligible. Patients with a previous diagnosis of another primary cancer will be excluded; patients undergoing surgery and/or chemotherapy at another institution; patients who previously had altered sensitivity in the feet; patients who are unable to answer the questionnaires and patients unable to receive photobiomodulation due to acute infections in the lower limbs. After recruitment, the women will be allocated into three groups: two Intervention groups (use of the IV and V LED board; and IV, V and Violet) and a Control group (use of the LED board without light emission). Peripheral neuropathy, pain, global muscle strength, body balance, sensitivity, health-related quality of life and related independent variables will be evaluated, such as the characteristics of the patient, the tumor and the oncological treatment performed. Data analysis: Statistical analysis will be conducted following intention-to-treat principles. Data normality will be tested using the Kolmogorov Smirnov test, considering as normal distribution those with p > 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Only outcome assessors and patients will be blinded to group allocation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged over 18 years, with breast cancer in stages I to IIIC and who have an indication for curative treatment with neoadjuvant or adjuvant chemotherapy in HCIII/INCA.

排除标准

  • Patients with a previous diagnosis of another primary cancer
  • Patients undergoing surgery and/or chemotherapy at another Institution
  • Patients who previously had altered sensitivity in the feet
  • Patients who are unable to respond to questionnaires
  • Patients unable to receive photobiomodulation due to acute lower limb infections

结局指标

主要结局

Peripheral neuropathy

时间窗: Until the conclusion of the study, on average 14 months

Chemotherapy Induced Peripheral Neuropathy Assessment Tool (FANPIQ), which is validated and translated from the Chemotherapy Induced Peripheral Neuropathy Assessment Tool - (CIPNAT).

次要结局

  • Lower limb sensitivity(until the conclusion of the study, on average 14 months)
  • Satisfaction with the use of photobiomodulation(Until the conclusion of the study, on average 14 months)
  • Overall Muscle Strength(Until the conclusion of the study, on average 14 months)
  • Lower limb pain(Until the conclusion of the study, on average 14 months)
  • Body Balance(Until the conclusion of the study, on average 14 months)
  • Health-related quality of life(Until the conclusion of the study, on average 14 months)
  • Assessment of Adherence to Treatment(Until the conclusion of the study, on average 14 months)
  • Impact of Peripheral Neuropathy on Activities of Daily Living(Until the conclusion of the study, on average 14 months)

研究者

发起方
Erica Alves Nogueira Fabro
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Erica Alves Nogueira Fabro

Technical manager

Instituto Nacional de Cancer, Brazil

研究点 (2)

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