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

Any patient who is going through radiation to their chest wall following mastectomy using a rotational delivery technique and 6 MV, and uses Superflab bolus for some but not all fractions of radiotherapy

During a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes.

Brass Mesh Bolus

Hannah Dahn, MD

The hypothesis is that the daily use of brass mesh bolus achieves a comparable dose to every-other-day use of Superflab bolus (current standard of care) in chest wall post-mastectomy patients treated with rotational 6 MV photon delivery.

Intervention: During a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes.

Comparator: Superflab and no bolus applied as per the treating physician's practice, typically on alternate days. The intervention and comparator tools are to be utilized on each participant.

Primary outcome

1. To determine the skin dose under brass mesh bolus and compare it with the skin dose under Superflab bolus (current standard of care).
2. To determine the number of fractions for which brass mesh bolus should be used to achieve an acceptable skin dose.

This is a single-site study designed to generate data quantifying the skin dose under brass mesh bolus.

Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy

A Clinical Trial to Assess Skin Dose in Post-mastectomy Adjuvant Radiation Therapy of Breast Cancer Patients Using a Brass Mesh Bolus

During days one, two, and three of radiation therapy, patients on this study utilize no-bolus, 5-mm thick Superflab bolus, and brass mesh bolus, respectively. Each day, nine in-vivo dosimeters (OSLDs) will be placed on patient skin to sample the skin dose in cGy. As a result, for each patient on this study, skin dose enhancement of brass mesh compared with no-bolus can be related to that of Superflab bolus. At the end of the study, the average and range of skin dose enhancement under brass mesh bolus for a sample size of twenty patients will be reported.

Hannah Dahn

Nova Scotia Cancer Centre

Medical Physicist

Head and Neck Neoplasms

Upon tube feeding initiation determined by the HNC multidisciplinary team, the patients will be randomized into three different groups, each consisting of 20 patients each: Bolus (Group 1), Gravity (Group 2), and Pump (Group 3). The randomization process within these three groups will based on 1) age and 2) estimated caloric need. For example, if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either Bolus, Gravity or Pump group. Another example is that if we have two 45-year-old patients whose estimated needs are 2400kcals/day, then one patient will randomly be assigned to the Bolus group, and the other one will be randomly assigned to the Gravity group. The third patient that will fit that category will be assigned to the Pump group.

The patients will be randomized into 3 different groups: Bolus, Gravity, and Pump. The randomization process will be based on age and estimated caloric needs (i.e if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either of the groups).

Each patient from each group will be receiving tube feeding education to their by RD. For consistency reasons, the same type of tube feeding formula (1.5 kcal/ml, no fiber) will be used. Patients' weight, tube feeding tolerance, and amount of estimated calories and protein met will be monitored weekly.

Bolus

Gravity

Pump

Andreea Nguyen, MS in Nutrition

The purpose of this study is to assess the optimal tube feeding method (bolus, gravity or pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck undergoing chemoradiation therapy.

It is a great challenge to maintain the nutritional status of the head and neck cancer (HNC) patients through treatment advances such as combined chemoradiation therapy or CRT. For all these reasons, HNC patients undergoing treatment, frequently require alternate methods of nutrition support such as as enteral tube feeding via a gastrostomy tube.Upon gastric tube feeding initiation, the registered dietitian (RD) must consider the three different methods: bolus (using a syringe), gravity (using gravity feeding bags), and pump (using a tube feeding pump).

Typically, patients are started on bolus (OPTION A), changed to gravity (OPTION B) if bolus feeds are not tolerated, and ultimately changed to pump (OPTION C) if gravity feeds are not tolerated. The concern is that in this process of starting with OPTION A, and moving to OPTION B or further to OPTION C, the patient may experience unintentional weight loss and dehydration related to tube feeding intolerance and/or tube feeding inadequacy. Consequently, this places the patient at risk of, but not limited to, hospital admission for dehydration and/or malnutrition, and treatment interruption. Therefore, exploring the idea of an optimal feeding method and starting patients on it from the beginning, may improve patient outcomes in terms of nutritional status.

Optimal Tube Feeding Method in Head and Neck Cancer Patients

The Optimal Tube Feeding Method in Head and Neck Cancer Patients: A Comparison Between Bolus, Gravity, and Tube Feeding Pump.

Baylor Research Institute

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Recurrence

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Bortezomib

Proteasome Inhibitors

bortezomib

Janssen Pharmaceutical K.K. Clinical Trial

The purpose of this study is to assess the safety/tolerability and determine the Japanese recommended dose (RD) of bortezomib administered as a once-daily intravenous bolus twice weekly for 2 consecutive weeks(Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 to 21) in Japanese patients with relapsed or refractory multiple myeloma.

In Japan, there is no clear treatment guidance for patients with multiple myeloma that repeatedly relapsed and became refractory. At present, various therapies including other multi-drug combination chemotherapy, hematopoietic stem cell transplantation, corticosteroid massive therapy, interferon therapy, thalidomide therapy, radiation therapy and other experimental therapies are conducted exploratory as salvage therapies to find the one to which the patient shows response. Considering that the antitumor activity of JNJ-26866138 against relapsed or refractory MM is clear and and the tolerability is acceptable based on results of the overseas clinical studies, the development of JNJ-26866138 in Japan is quite meaningful. This is a non-randomized, open-label, multicenter dose-escalation study which consisting of the two parts: the Phase I part is intended to intravenously administer JNJ-26866138 twice daily for 2 weeks (Days 1, 4, 8, and 11) to establish the Japanese RD based on the incidence of dose limiting toxicities (DLTs), while the Phase II part is intended to evaluate the efficacy and safety of JNJ-26866138 in patients repeatedly treated at the Japanese RD.

Based on the body surface area calculated before treatment in each cycle, the dose is calculated for each patient according to the dose level specified by the Patient Enrollment Center (0.7mg/m2, 1.0 mg/m2 or 1.3 mg/m2). JNJ-26866138 is intravenously administered once daily, twice weekly for 2 weeks (Days 1, 4, 8, and 11), followed by a 10-day rest period (Days 12 to 21). This is considered one cycle (21 days), and treatment is repeated up to 6 cycles in patients expected to show a response.

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
Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy	NCT05483712	Breast Cancer	Brass Mesh Bolu...	-	Nova Scotia Cancer Centre
Optimal Tube Feeding Method in Head and Neck Cancer Patients	NCT01536782	Head and Neck C...	Bolus Gravity Pump	18 Years -	Baylor Research Institute
A Japan Phase I/II Study of Bortezomib in Relapsed or Refractory Multiple Myeloma Patients	NCT00752518	Refractory Multiple Myelom... Relapse	bortezomib	20 Years - 75 Years	Janssen Pharmaceutical K.K.

Spots Global Cancer Trial Database for bolus

Every month we try and update this database with for bolus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bolus

Every month we try and update this database with for bolus cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bolus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.