CompletedNot Applicable

Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema

France93 participantsStarted 2015-09

Plain-language summary

This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients suffering from a lymphoedema consequence of a breast cancer of grades 2 or 3 (ISL) * Patients suffering from Lymphoedema for 6 months or more * Patients with a difference between arms \>10% * Patients who had ever had an axillary node dissection * Patients hospitalized for intensive standard treatment. Exclusion Criteria: * Primary lymphoedema * Venous insufficiency of the upper members * severe arterial obstruction * obliterating arteritis of the upper limbs * Bilateral lymphoedema * Breast cancer recurrence * Another cancer in treatment * Decompensated heart failure * Pacemaker * acute infection * Deep venous thrombosis * Skin atrophy of the upper member * Bullous dermatosis * Acute dermatitis with epidermitis or dermatitis-hypodermitis * Infected wound * Inflammatory scar or consequence of a recent surgery (\<1 month) * Presence of osteosynthesis equipment under the skin with an external part in the upper member to treat * Hyperalgesia of the shoulder * Pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)

Timeframe: 6 months

Trial details

NCT IDNCT02506530

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

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