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Идёт набор NCT06297265

Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery

Без фазы С лечением Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Localized Breast Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lymphedema Management, Questionnaire Administration, Adjuvant breast radiation therapy.
Кому может быть актуально
Состояния в реестре: Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Localized Breast Carcinoma. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Feasibility and Effects of Manual Lymphatic Drainage (MLD) Breast Massage in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy

Обзор

This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer.

Подробное описание

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.

SECONDARY OBJECTIVES:

I. Evaluate the tolerability of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.

II. Preliminarily assess the effect on acute and chronic breast edema, pain, functional status, quality of life, body image and radiation induced fibrosis (RIF).

OUTLINE:

Patients undergo MLD breast massage over 30-60 minutes twice a week (BIW) for the duration of standard of care (SOC) radiation therapy and for 1 month thereafter.

After completion of SOC radiation therapy, patients are followed up at 2-4 weeks and 3, 6, and 12 months.

Вмешательства

  • Другое Lymphedema Management
    Undergo MLD breast massage
  • Другое Questionnaire Administration
    Ancillary studies
  • Лучевая терапия Adjuvant breast radiation therapy
    Using standard 3D conformal or intensity modulated techniques, patients will receive standard fractionation or moderate hypofractionation radiation therapy. The radiation treatment will last for 3 to 6 weeks, with the length of treatment depending on patient's specific clinical situation.

Первичные конечные точки

  • Rate of compliance of MLD breast massage sessions [Срок оценки: Up to 1 month after completion of radiation]
Вторичные конечные точки (5)
  • Assess the effect of MLD breast massage breast edema [Срок оценки: Up to 1 year]
  • Assess the effect of MLD breast massage on pain [Срок оценки: Up to 1 year]
  • Assess the effect of MLD breast massage on functional status [Срок оценки: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)]
  • Assess the effect of MLD breast massage on quality of life [Срок оценки: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)]
  • Assess the effect of MLD breast massage on body image [Срок оценки: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)]

Критерии участия

Критерии включения

  • Female with native breasts and localized breast cancer who are status post-lumpectomy surgery, will receive whole breast radiation therapy with/without nodal irradiation, with standard fractionation or moderate hypofractionation
  • Age >= 18 years
  • Ability to understand and the willingness to sign a written informed consent in English or Spanish

Критерии исключения

  • Underlying diagnosis of chronic inflammatory illness or collagen vascular disorder, e.g. scleroderma, lupus, rheumatoid arthritis, fibromyalgia as these conditions may significantly affect the likelihood and magnitude of radiation related toxicity
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Inability to provide written informed consent in English or Spanish
  • Patients receiving ultra-hypofractionation, and/or partial breast or chest wall radiation therapy are excluded

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • USC / Norris Comprehensive Cancer Center — Los Angeles

Идентификаторы

NCT: NCT06297265 · 1B-23-2 · NCI-2023-10828 · 1B-23-2 · P30CA014089

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗