Breast Cancer

The investigational medical product of this study is a biomedical repair mask, FR-MASK, acting like moisturizing lotion applied on breasts.
The FR-Mask is applied to users' radiation-irritated breast skin for 15 to 20 minutes every 3 days.

FR-Mask

China Medical University Hospital

A Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy

A Single-arm, Open Label, Single Center Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy

Breast Cancer Treatment Outcome: Scale 1 = no difference between treated and untreated breast and area; 2 = slight difference between treated and untreated breast and area; 3 = moderate difference between treated and untreated breast and area; 4 = large difference between treated and untreated breast and area

Ying-Chun Lin

Attending Physician, Division of Radiation Oncology, Principal Investigator

Nivolumab

Doxorubicin; weekly low dose doxorubicin 15mg iv

Doxorubicin

NKI-AVL

Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO

Pre-operative Phase II Trial for Breast Cancer With Nivolumab in Combination With Novel IO (BELLINI Trial)

measuring the tumor-associated CD8 and expression of genes induced by IFNy after pre-operative immunotherapy

Adverse events in all regimens will be graded according to NCI Common Toxicity Criteria version 5.0.

The percentage of patients having a complete response, partial response or stable disease per cohort assessed by MRI

The percentage of patients having a complete response or residual cancer burden per cohort

The Netherlands Cancer Institute

Bristol-Myers Squibb

Separate cohorts will be opened in this trial. LumB and TNBC tumors will be divided in separate cohorts.More cohorts, e.g. combining nivolumab and novel IO, can open after the start of this trial.

Group 1: Subjects receiving 20 g/day of Tualang honey. The honey used was from a single batch honey supplied by Federal Agricultural Marketing Authorities (FAMA), Malaysia, evaporated by FAMA to achieve a water content of about 20%, submitted to Sterile Gamma company at Shah Alam, Selangor for sterilization at 25 kGy and packed in 20 g sachet in collaboration with School of Pharmaceutical Sciences laboratory.

Group 2: Subjects receiving hormonal replacement therapy (Femoston®), also known as Femo conti 1/5 (contain 1 mg Estradiol valerate and 5 mg Dydrogesterone) supplied by Solvay Pharma Malaysia.

Postmenopausal Syndrome

This was a randomized, prospective, clinical study to evaluate the effect of Tualang honey in comparison with HRT. Subjects will be confined to healthy postmenopausal women who were naturally menopause for more than one year. The study period was four months. A total of 79 patients were recruited.
Group 1: Subjects receiving 20 g/day of Tualang honey. The honey used was from a single batch honey supplied by Federal Agricultural Marketing Authorities (FAMA), Malaysia, evaporated by FAMA to achieve a water content of about 20%, submitted to Sterile Gamma company at Shah Alam, Selangor for sterilization at 25 kGy and packed in 20 g sachet in collaboration with School of Pharmaceutical Sciences laboratory.
Group 2: Subjects receiving hormonal replacement therapy (Femoston®), also known as Femo conti 1/5 (contain 1 mg Estradiol valerate and 5 mg Dydrogesterone) supplied by Solvay Pharma Malaysia.

Tualang honey

Clinical Trial Unit, Hospital USM

The Effects of Tualang Honey on Postmenopausal Women

The Effect of Tualang Honey and Hormonal Replacement Therapy (HRT) on Safety Profiles Among Postmenopausal Women

To evaluate the safety profile of honey in term of haematological and biochemical profile

To assess the changes in cardiovascular parameters
blood pressure
waist circumference
total cholesterol
high density lipoprotein
low density lipoprotein
fasting glucose

follicular stimulating hormone (FSH)
luteinizing hormone (LH)
testosterone
estradiol

To assess the effects on bone density through bone densitometry (DEXA)

Associate Professor Dr Nik Hazlina Nik Hussain

Universiti Sains Malaysia

four, 250mg tablets daily 5-14 days prior to surgery

tonic/breast neoplasms

A Study to Evaluate the Safety and Clinical Outcome of Using FR-Mask in Breast Cancer Patients With Radiation-irritated Skin After Radiotherapy

Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO

The Effects of Tualang Honey on Postmenopausal Women

A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer

Stress, Diurnal Cortisol, and Breast Cancer Survival

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