Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Radiodermatitis

Breast Diseases

Skin Diseases

Dermatitis

Radiation Injuries

No Bolus

Alternate Bolus

Continuous Bolus

Lucas G Sapienza, MD, PhD

The aim of this study is to evaluate the impact of adding bolus in adjuvant radiotherapy after mastectomy, in relation to the time of treatment interruption and acute effects. This study evaluates whether there is an increase in treatment time with the addition of the bolus, which can overshadow the benefit of increased dose to the skin and subcutaneous tissue. The patients will continue to be followed for oncologic outcomes, focusing on chest wall local control.

Rational:

* The use of high-energy photons (6 MeV) creates a characteristic skin-sparing effect, which can generate a region of low-dose subcutaneous tissue.
* The subcutaneous tissue is a possible area of clinical failure in the chest wall after mastectomy for breast cancer.
* To optimize treatment, it is used a bio-equivalent material to increase the surface dose.
* This dose increase may be accompanied by greater skin reaction, making it necessary to temporarily discontinue treatment to recover radiodermatitis.
* The total treatment time is a determinant of tumor control in the treatment of cancer with radiation.

Description:

* This study aims to evaluate whether different intensities of application of the bolus correlate with greater likelihood of treatment discontinuation.
* This will be a single blind randomised controlled trial. The target population comprises patients with indication of post mastectomy radiation (PMRT).
* The patients will be divided into two groups: one with higher risk of recurrence in subcutaneous, which will be randomized to use 0.5cm bolus every other day or on consecutive days, and one lower risk group, which will be randomized to use bolus 0.5cm on alternate days or do not use bolus. The group with high risk is defined as patients with clinical or pathological tumor invasion of skin. The others will be considered standard risk.
* Randomization will be made so that each group has the same proportion of patients with high body mass index (\> / = 30 kg/m2), as this may be a factor in worsening radiodermatitis.
* The patients will be followed during treatment and will be evaluated weekly for the radiodermatitis, interruption time of treatment for recovery from the acute effects and expenditures for local care. The evaluation will be done blindly (without knowledge of the utilization of bolus) by trained nurses in the management of radiodermatitis. After treatment, patients will continue to be followed for oncologic outcomes, focusing on chest wall local control.

Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer

Randomized Clinical Trial of the Impact of the Use of Bolus in the Treatment of Post Mastectomy Radiotherapy for Breast Cancer

local control in the chest wall assessed by physical examination and complementary exams.

Metastasis-Free Interval (following departmental post-treatment surveillance visits routine).

Overall Survival (following departmental post-treatment surveillance visits routine).

Radiation Therapy Oncology Group (RTOG) grading system Common Terminology Criteria for Adverse Events (CTCAE) - v4.0

Treatment Interruption time due to radiodermatitis

AC Camargo Cancer Center

Medical Doctor

Primary Surgery: Skin sparing mastectomy (nipple sparing if appropriate) and axillary surgery according to guidelines or protocol. Reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix.

Delayed reconstruction: Final reconstruction with any reconstructive procedure - being it autologous or implant-based (one- or two-stage, +/- acellular dermal matrix (ADM)) - is performed 6-12 months after completion of chemotherapy and PMRT. Any contralateral procedure is allowed when doing the delayed surgery, but not in relation to the initial cancer surgery.

Primary surgery: Total mastectomy and axillary surgery according to guidelines or protocol.

Delayed reconstruction: 6-12 months after completion of PMRT: final recon-struction with any reconstructive procedure - being it autologous or implant-based (one-or two-stage, +/- ADM). Any contralateral procedure is allowed at any time point after PMRT has been delivered This arm has been closed nov 2023

Skin sparing mastectomy and reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix. Final reconstruction with any reconstructive procedure 6-12 months after completion of chemotherapy and RT.

Delayed-immediate reconstruction

Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT

Delayed reconstruction

Tove F Tvedskov, DMSc

Peer M Christiansen, Professor

Tove Tvedskov

Rikke Bredgaard

Lisbeth Hölmich

Lone Bak Hansen

Tine Damsgaard, Professor

Birgitte V Offersen, Professor

Peer Christiansen, Professor

Majbrit Jensen, MSc

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.

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

The study started as a randomized trial but was november 2023 changed for a prospective single arm tieal

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

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

Number of patients with complication deeming surgical intervention necessary (excluding percutaneous drainage and antibiotic treatment for inflammation in cases without need for open drainage):

* Infection
* Hematoma
* Loss of implant/expander
* Necrosis
* Seroma

Number of patients with complication (Infection with need for antibiotics and/or necrosis) without intervention necessary

Degree of Depression measured by Becks Depression Inventory, BDII using a scale from 1 to 4, 4 being the worst

Fear of cancer recurrence measured by Concerns About Recurrence Questionnaire-3 (CARQ-3 ) on a scale from 1 to 10, 10 worst (fear all the time)

Patient satisfaction and QoL measures by the BREAST-Q-instruments on a scale from 1 to 5, 5 being worst

Time from primary surgery to start of adjuvant therapy

Patient reported morbidity measured by a questionnaire. The prevalence of pain will be assessed on a 0-10 numerical rating scale (NRS) and reported as: 'light pain' NRS 1-3; 'moderate pain' NRS 4-6; and 'severe pain' NRS 7-10. Sensory disturbances will be assessed by a dichotomous 'yes/no' question,. Lymphoedema will be assessed on a 0-10 numerical rating scale, 10 being worst. Body image will be assessed on a 0-7 numerical rating scale, 7 being best.

Difference in arm circumference between arms 15 cm/10 cm proximal/distal to the olecranon bilaterally. Any difference ≥10% defines lymhoedema.

Differences between arms in range of motion of the shoulder measured at abduction/flexion with the patient sitting in front of a poster with a circle with degrees 0-180˚.Any difference ≥10 degrees defines defines restricted motion

Degree of capsular Contracture using Baker grading

Aesthetic outcome scored bt the physician using breast Photo, on a scale from 0 to 3, 3 being worst

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer	NCT01925651	Breast Cancer Radiodermatitis	No Bolus Alternate Bolus Continuous Bolu...	18 Years -	AC Camargo Cancer Center
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy	NCT03730922	Breast Neoplasm... Complication of... Breast Implant;...	Delayed-immedia... Delayed reconst...	18 Years -	Danish Breast Cancer Cooperative Group
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy	NCT03730922	Breast Neoplasm... Complication of... Breast Implant;...	Delayed-immedia... Delayed reconst...	18 Years -	Danish Breast Cancer Cooperative Group

Spots Global Cancer Trial Database for post mastectomy radiotherapy