Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Breast Neoplasms

Lymphedema

Neoplasm Metastasis

Breast Cancer Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Postoperative Complications

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Pirfenidone

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

BCRL patients will receive LYT-100 BID for 6 months

LYT-100 BCRL

BCRL patients will receive Placebo BID for 6 months

Placebo BCRL

This is a trial of up to 6-months duration for safety, tolerability, clinical efficacy assessments, PK and biomarkers analysis in breast carcinoma patients with secondary lymphoedema

This trial will utilize a randomised, double-blinded, placebo controlled design that will assess the safety, tolerability, and secondarily clinical efficacy of LYT-100 over a period of up to 6-months of dosing in breast carcinoma patients with secondary lymphoedema following sentinel lymph node biopsy and/or axillary node dissection, with or without radiation.

Consists of 1 cohort with 2 arms: active treatment or placebo patients

LYT-100 in Patients With BCRL

A Phase 2a Double-Blind, Placebo-Controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of Deupirfenidone (LYT-100) in Patients With Breast Cancer-Related Upper Limb Secondary Lymphoedema

Evaluate the safety and tolerability of LYT-100 as measured by TEAEs

Novotech (Australia) Pty Limited

PureTech

Systemic Assessment methods were used to routinely evaluate if any adverse events have occurred. Examples of these methods include: regular investigator assessments through physical exams and laboratory testing.

LYT-100 BID for 6 months

LYT-100 BCRL: BCRL patients will receive LYT-100 BID for 6 months

Placebo BID for 6 months

Placebo BCRL: BCRL patients will receive Placebo BID for 6 months

Placebo in Patients With BCRL

LYT-100 BID for 6 months

LYT-100 BCRL: BCRL patients will receive LYT-100 500mg BID x3 days followed by LYT-100 750mg BID for 6 months

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Australia

Region of Enrollment

Director of Clinical Trials

Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

LYT-100 BID for 6 months

LYT-100 BCRL: BCRL patients will receive LYT-100 500 mg BIDX3 days followed by LYT-100 750 mg BID for 6 months

Overall Study

Control group will have standard of care, consisting of verbal and written information on lymphoedema prevention and standard access to breast care nurse.

Decongestive lymphatic therapy (DLT). DLT group will involve manual lymphatic drainage with a trained manual lymphatic drainage therapist.

Decongestive lymphatic therapy (DLT)

Standard Care

Axillary lymph nodes are the main site of metastasis in breast cancer. If positive axillary lymph nodes are present, an axillary lymph node dissection (ALND) is usually performed. This procedure improves disease-free survival but comes with the risk of lymphoedema as a result of disrupted lymphatic channels. Breast cancer-related lymphoedema (BCRL) is associated with considerable morbidity, which is why proven measures to reduce its incidence would improve patient outcomes. We aimed to investigate whether a regime of manual lymphatic drainage and exercise, supervised by a manual lymphatic drainage therapist compared to standard care would reduce the incidence of breast cancer-related lymphoedema in patients undergoing ALND.

Eligible patients were those in whom a primary operable breast cancer is diagnosed and in whom surgery is planned to include ALND. Patients with recurrent carcinoma, previous axillary surgery/radiotherapy or any previous arm/axillary pathology leading to arm volume changes will be excluded. Eligible participants will be identified at the breast multidisciplinary meeting and will be informed of the study and given a written information sheet. Patients who choose to participate will be asked to fill in a written consent form. Patients allocated to the decongestive lymphatic therapy group will undergo intervention for a total period of 3 months. This will consist of 2 visits to a qualified practitioner in Dr Vodder manual lymphatic drainage therapist, one at the start of the 3-month period and again 6 weeks later. Patients in both groups will also be instructed to perform self-MLD on a daily basis and will be taught a series of exercises to be performed on a daily basis. Compression hosiery will be fitted to be worn during the exercises.

Manual Lymphatic Drainage Versus Standard Treatment for the Prevention of Breast Cancer-related Lymphoedema in Patients Who Undergo Axillary Node Clearance

Does a Regime of Manual Lymphatic Drainage Reduce the Incidence of Breast Cancer-related Lymphoedema Following Axillary Node Clearance: a Randomised Controlled Trial

The primary outcome was the absolute difference in arm volumes between the affected and the contralateral arms.

The patient's acceptability of physiotherapy exercises will be sought via questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
LYT-100 in Patients With BCRL	NCT04243837	Breast Cancer R... Lymphoedema	LYT-100 BCRL Placebo BCRL	18 Years - 80 Years	PureTech
Manual Lymphatic Drainage Versus Standard Treatment for the Prevention of Breast Cancer-related Lymphoedema in Patients Who Undergo Axillary Node Clearance	NCT04582565	Breast Cancer R...	Decongestive ly... Standard Care	- 120 Years	Norfolk and Norwich University Hospitals NHS Foundation Trust

Spots Global Cancer Trial Database for breast cancer related lymphoedema