- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00282529
Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background: Lymphedema has varied definitions, all based on limb volume changes. None incorporates limb volume changes, symptoms, and functional deficits. We will determine the incidence of lymphedema in breast cancer patients and the impact of breast conserving therapy, radiation therapy, sentinel lymph node biopsy, and axillary node dissection. The impact of lymphedema can be evaluated in a number of ways; 1) The Lymphedema and Breast Cancer Questionnaire (LBCQ) identifies symptoms that are unique to patients with lymphedema and 2) The Disability of the Arm, Hand, and Shoulder (DASH) survey will be used to determine the functional impact of lymphedema.
Objective/Hypothesis: Our hypotheses are: 1) Local therapies for breast cancer result in different lymphedema rates depending on the combination of therapies used. 2) A simple screening tool that incorporates symptoms, limb volume measurements, and tumor staging and treatment modalities can predict those patients that will develop lymphedema. 3) Functional impairment of the arm is severe in patients with lymphedema. 4) Prevention of lymphedema in a high risk population is possible with education, a compression sleeve, and decongestive exercise.
Specific Aims: 1) Evaluate patients both pre-operatively and at specific time intervals post-operatively to establish the incidence of lymphedema in sentinel lymph node biopsy and axillary dissection groups. 2) Create a simple screening tool using arm measurements, symptoms identified by the LBCQ, and treatment and staging information to identify patients that should go on to further testing and treatment. 3) Utilize the DASH survey to measure the extent of disability from lymphedema and surgical treatment. 4) Conduct a randomized trial of lymphedema prevention in a high-risk breast cancer population.
Study Design: This proposal will be conducted in two phases. Phase 1 will accomplish Specific Aim 1, 2, and 3. Patients with newly diagnosed breast cancer awaiting definitive surgery, will be enrolled pre-operatively and undergo arm measurements and complete the LBCQ and the DASH surveys. These same study procedures will be completed at 1, 3, 6, 12, 18, and 24 months postoperative. Documentation collected during the study will include: demographic information; co-morbid conditions; operative and pathology reports; and use of adjuvant therapies such as chemotherapy, hormonal therapy, and radiation therapy. Incidence rates of lymphedema and the impact of extent of surgery and radiation therapy will be determined. We will also use this information to develop a simple screening tool to identify patients that will develop lymphedema prior to the development of significant limb volume changes. Specific Aim 4 is Phase 2 of the proposal. A high risk population (those that have an axillary node dissection and radiation therapy) will be randomized to standard education versus standard education, compression sleeve, and exercise. The effectiveness of prevention to reduce incidence and severity of lymphedema and the impact on symptoms and functional impairment will be determined. This work will move toward a new paradigm of lymphedema management with a simple screening tool to identify high risk patients before significant swelling occurs and investigate prevention strategies to decrease the incidence of lymphedema.
Cancer Relevance: Lymphedema is a feared complication of breast cancer treatment. Currently it is recognized and treated only after development of significant limb volume changes when it is symptomatic and difficult to treat. Documentation of the impact of local therapies on the development of lymphedema will allow clinicians to make more informed decisions regarding risk benefit ratios of each of our local therapies. Development of a screening tool will allow us to identify high risk populations. Ideally, the high risk population will be identified and an effective prevention strategy implemented. Phase one of this study will help to answer the questions regarding incidence and create a screening tool and phase two will allow the evaluation of a prevention strategy.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Maryland
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Baltimore,, Maryland, États-Unis, 21287
- Avon Breasts Center, Johns Hopkins Medical Institutions
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Age of 18 years or older, biopsy proven breast cancer with no known metastatic cancer, surgical management of breast cancer with node evaluation to be completed at Johns Hopkins Hospital, ability to speak and read English, willing and able to continue follow-up at Johns Hopkins Avon foundation Breast Center -
Exclusion Criteria: Known psychiatric illness, unwillingness to be followed for two years, functional arm deficits, prior radiation therapy to the breast or axilla, any prior diagnosis of cancer except basal cell cancer
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Bilateral arm measurements, Lymphedema and Breast Cancer Questionnaire, Disability of the Arm and Shoulder and Hand(DASH)Questionnaire
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Mesures de résultats secondaires
Mesure des résultats |
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Standard lymphedema risk reduction education, Lymphedema prevention
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Lisa Jacobs, M.D., Johns Hopkins Medical Institutions, Department of Surgery
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- J05101
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Essais cliniques sur Cancer du sein
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AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie