- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00383500
Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The current investigation is designed to prospectively evaluate the potential for simple, effective lymphedema prophylaxis in breast cancer survivors who show early evidence of high-risk status. There is growing evidence that the mechanisms of lymphatic repair after injury are mediated through lymphatic flow. Accordingly, this study assess if physical measures designed to prophylactically augment lymphatic flow after surgical interventions for breast cancer (eg, Flexitouch and manual lymphatic massage) will reduce the incidence of lymphatic stagnation, assessed as incidence of lymphedema, when compared to patients who receive conventional "watch and wait" interventions (observation).
The specific aims of the study are
- to prospectively assess the presence of newly developing lymphedema in each study subgroup through serial assessment of segmental interstitial fluid content by multiple frequency bioimpedance
- to evaluate the preventive interventions in a prospective, randomized fashion, contrasting the responses of equivalent numbers of patients randomized to 2 experimental arms and the control arm of the study
- to correlate the bioimpedance findings with concurrently derived, serial assessments of limb volume
Recent advances in the medical understanding of the biological processes of lymphatic development and repair suggest that these mechanisms may be able to be manipulated to enhance the regenerative responses in the lymphatic vasculature following injury. Breast cancer-associated lymphedema is a model of such an acquired form of lymphatic vasculature insufficiency. Clinically, this poses a substantial clinical problem. It is estimated at 1woman in 4 who survives a breast cancer intervention will develop lymphedema, often progressively. The appearance of lymphedema has documented adverse effects on physical and psychologically well-being. New insights into lymphatic repair suggest that such mechanisms can be employed in a prophylactic fashion to forestall or eliminate the development of lymphedema. This proposal investigates this hypothesis in a prospective fashion, using a randomized trial design in 80 patients enrolled at the time of breast cancer surgery. If the investigation documents a beneficial effect of preventive measures, it could have a profound impact on subsequent breast cancer care. These measures are simple and cost-effective and, could help to eliminate the impact of a substantial detractor to the improved longevity and health that breast cancer survivors otherwise may expect to enjoy.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Stanford, California, Förenta staterna, 94305
- Stanford University School of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Unilateral breast cancer
- Scheduled to undergo breast surgery and axillary lymph node dissection, with or without breast conserving techniques.
- Referred to the surgeons of the Stanford University Breast Cancer Program
- Capacity to provide informed consent.
- All experimental protocols will be reviewed and approved by the Stanford Institutional Review Board for the Protection of Human Subjects.
Exclusion Criteria:
- Other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
- Recurrent breast cancer or other forms of pre-existing lymphedema.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Flexitouch device
Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
|
A standard of care intermittent pneumatic compression device (aka, lymphedema pump)
Andra namn:
|
Experimentell: Manual Lymphatic Drainage (MLD)
Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment
|
Manual lymphatic drainage therapy to provide lymphatic massage, using a Class 1 compression garment supporting the arm during heavy exercise or where the risk of trauma maybe increased (ie, flight, elevation, etc).
Andra namn:
|
Inget ingripande: Observational Control (no intervention)
Control group, no intervention.
No Flexitouch or manual massage therapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy
Tidsram: 36 months
|
Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups
|
36 months
|
Incidence of Lymphedema (Newly-developing)
Tidsram: 3 years of semi-annual follow-up
|
Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues.
|
3 years of semi-annual follow-up
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB-01671
- 95970 (Annan identifierare: Stanford University Alternate IRB Approval Number)
- BRSNSTU0007 (Annan identifierare: OnCore Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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