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Spots Global Cancer Trial Database for Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy

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Trial Identification

Brief Title: Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy

Official Title: The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized and Single Arm Clinical Trial

Study ID: NCT03730922

Study Description

Brief Summary: In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication. In this trial the safety of the delayed-immediate reconstruction method is tested, where a skin sparing mastectomy and reconstruction with silicone implant is performed at primary surgery to save the native skin for the final delayed reconstruction.

Detailed Description: An increasing proportion of breast cancer patients treated by mastectomy wish for a breast reconstruction. If post-mastectomy radiation therapy is recommended, the reconstruction is often delayed until 6 - 12 months after completion of chemotherapy and radiation therapy due to risk of complication that might delay adjuvant treatment. At this time the native skin over the removed breast cannot be used in the reconstruction, resulting in a suboptimal aesthetic outcome. In the delayed-immediate reconstruction method, a skin sparing mastectomy and reconstruction with implant is performed at primary surgery, to save the native skin under radiation therapy, thereby improving the chance for a good aesthetic outcome at the final delayed reconstruction. In this trial breast cancer patients treated by mastectomy and loco-regional radiation therapy is randomized to either delayed reconstruction or delayed-immediate reconstruction. The complication rate as well as morbidity, aesthetic outcome and psychological well-being after delayed-immediate reconstruction will be compared with delayed reconstruction

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Ålborg Universitetshospital, Aalborg, , Denmark

Gentofte Hospital/Herlev Hospital, Copenhagen, , Denmark

Esbjerg Sygehus, Esbjerg, , Denmark

Sjællands Universitetshospital, Roskilde, , Denmark

Vejle Sygehus, Vejle, , Denmark

Viborg Sygehus, Viborg, , Denmark

Åbenrå Sygehus, Åbenrå, , Denmark

Århus Universitets Hospital, Århus, , Denmark

Contact Details

Name: Birgitte V Offersen, Professor

Affiliation: DBCG

Role: STUDY_DIRECTOR

Name: Tove F Tvedskov, DMSc

Affiliation: DBCG

Role: PRINCIPAL_INVESTIGATOR

Name: Tine Damsgaard, Professor

Affiliation: DBCG

Role: STUDY_DIRECTOR

Name: Peer Christiansen, Professor

Affiliation: DBCG

Role: STUDY_DIRECTOR

Name: Majbrit Jensen, MSc

Affiliation: DBCG

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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