Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Lymphedema

Pain

Shoulder Pain

Breast Neoplasms

Breast Cancer Lymphedema

Lymphatic Diseases

Arthralgia

Joint Diseases

Neurologic Manifestations

Postoperative Complications

the patients will receive Ga-As Laser and traditional therapy three times a week for three months

the patients will receive Microcurrent Electrical Stimulation and traditional therapy three times a week for three months

the patients will receive traditional therapy three times a week for three months

Patient sits on a chair with back support and the two GA-AS laser ( 5 milli Watts \& 904 nm) probe will be applied one on the shoulder tip for 5 minutes and the other application another 5 minutes will be on the center of deltoid muscle. The main power of the laser switch will be turned on. The duration of the treatment will be 10 minutes.

Ga-As Laser

The patient sits on a chair with back support and the two electrodes from Microcurrent 850 unit device will be applied one on the shoulder tip and the other electrode on the center of the deltoid muscle. A wet cloth was placed between the electrode and the patient's skin. An adhesive tape was used to hold the electrode over the treated areas. The main power switch will be turned on. The treatment duration will be for 10 minutes.

Microcurrent Electrical Stimulation

the patients will receive traditional physical therapy in the form of manual lymphatic drainage , compression bandage, exercise to increase lymphatic drainage, skin care. and ROM exercises to improve shoulder mobility

traditional therapy

the aim of this study is to investigate the effect of GA-AS laser versus microcurrent on post-mastectomy shoulder pain and lymphedema.

Breast cancer is extremely rare before the age of 25. It reaches a high incidence in the decade from 40 to 50 and continuous to increase in the frequency into old age. Mastectomy is the traditional approach to remove the entire breast once the diagnosis was confirmed. The most common cancers are lung cancer in men and breast cancer in women, however despite the large numbers of people affected by cancer there is very little literature on the role of physiotherapists in cancer care. After mastectomy and the accompanying excision or radiation of adjacent axillary lymph nodes a patient is at risk of developing upper extremity lymphedema, shoulder pain and loss of shoulder motion.low-level laser light waves penetrate deeply into the skin, they optimize the immune responses of our blood. This has both anti-inflammatory and immunosuppressive effects. It is a scientific fact that light transmitted to the blood in this way has positive effects throughout the whole body, supplying vital oxygen and energy to every cell .Electrical stimulation is based on the fact that human body has an endogenous bioelectric system that enhances healing of bone fracture, soft tissue lesions and decreasing post-operative pain. The external current may serve to mimic the failed natural bioelectric currents, so that post-operative pain can be inhibited. It was reported that microcurrent electrical neuromuscular stimulation (MENS) is better in enhancing cellular physiology processes than other current of higher amplitude, microcurrent is effective in the management of open wounds, inflammation and pain. sixty patients will be randomly allocated to three groups; first one will receive laser+ traditional therapy, second one will receive microcurrent + traditional therapy and third one will receive traditional therapy three times a week for three months.

Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation

pain intensity will be measured by visual analogue scale

lymphedema volume will be measured by measuring the circumference of each segment of the limb between two consecutive circumferences as a truncated zone. The volume of the segment was calculated as V=h(C12 +C1C2+C22 )/12π, where V is the volume of the segment, C1 and C2 are the circumferences at the ends of the segment, and h is the distance between them (segment length)

Cairo University

principle investigator

Lymphaticovenous Micro-Anastomosis

Mauricio Moreno, MD

This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous micro-anastomosis in the distal arm will result in the reduction of volume and improvement in quality of life of patients with post-mastectomy lymphedema

A lymphatic diversion with lymphaticovenous microanastomosis will be performed.

A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema

Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.

University of Arkansas

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Count of Participants

Early termination leading to small numbers of subjects. Outcome measures not computed because data would not be statistically relevant.

Beth Scanlan

Early termination leading to small numbers of subjects.Outcome measures not computed because data would not be statistically relevant.

Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery

Overall Study

Breast Diseases

Skin Diseases

35Gy/ 15#/3weeks to chest wall and 40Gy/15#/3 weeks to supraclavicular fossa

Hypofractionated radiotherapy

Survival of breast cancer patients has improved with multimodality treatment. Hypofractionated radiotherapy (RT) is rapidly emerging as one of the options for breast cancer patients after breast conservation surgery (BCS) but data on postmastectomy radiation therapy (PMRT) with hypofractionation is lacking and there is always concern for the late effects of RT especially with regional nodal irradiation (RNI). The potential survival benefits of locoregional radiation needs to be balanced with late-term effects. There is a dearth of data on RNI with hypofractionation. Therefore, reporting late-term effects of radiation in these patients is of utmost importance, especially with hypofractionation. Very few patients were given PMRT or RNI in the START trials, so definitive conclusions about the safety of shorter fractionation RNI cannot be drawn from these studies.1-3 There are also studies from Canada and the US with similar dose fractionations in the PMRT setting with limited number of patients but without RNI.4,5 There is a world-wide need for data on PMRT and especially with RNI for patients with breast cancer with its late-term consequences. Because of this, many radiation oncology societies are hesitant in recommending hypofractionated RNI. It is also an area for potential research in breast cancer radiotherapy. We have published our clinical outcomes with 3 weeks of adjuvant local and RNI with hypofractionation in the past.6-10 In this study, we will report late-term effects of PMRT and RNI with this schedule in patients with stage II and III breast cancer from a single institute from India which is practicing hypofractionation since 1976.

Between January 1990 to December 2007, women with breast cancer who were given radical treatment with mastectomy, systemic therapy and RT at least 10 years ago were included. Eligible patients were recruited from the radiotherapy department record and these were on regular follow-up in the breast clinic. The study was approved by the departmental ethics committee. Clinical, pathological and treatment characteristics were taken from the patient file. Inclusion criteria were: female patients age ≥18 years of age, with invasive carcinoma of the breast, post mastectomy, complete microscopic excision of primary tumour and stage II or III disease treated with locoregional RT. Exclusion criteria were: breast conserving surgery, stage I or IV disease, past history of malignancy except (i) basal cell skin cancer or CIN cervix uteri or(ii) non-breast malignancy if treated with curative intent and at least 5 years disease-free or contralateral breast cancer, including ductal carcinoma in situ (DCIS), irrespective of date of diagnosis. Patients with bilateral breast cancer were also excluded.

Patients were treated in supine position on a breast board with ipsilateral arm abducted to 900. All patients were planned using 2-D fluoroscopic conventional simulator with two tangential fields to the chest wall and a single incident field to the axilla and supraclavicular fossa. Lateral border of supraclavicular fossa was up to deltoid insertion.

Radiotherapy dose delivered was 35Gy/15fractions /3 weeks to the chest wall. Dose was prescribed at mid separation. Bolus was used in all patients on alternate days, that is for 50% of treatment. In patients with positive margins bolus was used daily and a scar boost of 10Gy/4fractions was given. None of the patients had breast reconstruction. Supraclavicular fossa(SCF), axillary chain and internal mammary nodal irradiation (IMNI)6 was done with a single incident field. No posterior axillary field was used. The dose delivered was 40Gy/15fractions/3weeks. All patients were treated on linac or cobalt-60 machine.

A biologically effective dose(BED) of 35Gy/15fractions/3weeks is 75.1Gy in terms of 2Gy per fraction for late effects, 55.1Gy for tumour control, 45Gy for erythema and 42.3Gy for desquamation in case of local radiotherapy. The BED for RNI with this schedule is 90Gy, 65Gy, 52.5Gy and 49Gy for late effects, tumour control, erythema and desquamation, respectively.

Patients were seen by the radiation oncologists with special focus on chest wall fibrosis, telangiectasia, shoulder function, lymphedema, arm pain and sensory symptoms. Late fibrosis was defined grade 1 as barely palpable firmness, grade 2 as definite increased firmness and grade 3 as marked firmness of the chest wall. Telangiectasia was defined grade 1 as \<1cm2, grade 2 as 1 cm2-4 cm2 and grade 3 as \>4 cm2 area of chest wall. Lymphedema was graded by measuring arm circumference 10cm above and below the medial epicondyle of humerus . For lymphedema and shoulder function, the treated side was compared with the untreated opposite side as a reference. Lymphedema was classified as none, mild, moderate and marked if there was no difference, 0.5-2cm, 2.1-3cm and \>3cm difference, respectively in the circumference of the affected and normal arm. If the patient had symptoms of pain in the arm, paresthesia, numbness, weakness, or other sensory symptoms then injury to the brachial plexus was suspected and reported as brachial plexopathy. A four point scale(none, a little, quite a bit, very much ) was used to assess all late effects according to the RTOG LENT SOMA scale. Late lung toxicity was defined grade 1 as asymptomatic or mild symptoms of dry cough, slight radiographic changes; grade 2 as moderate symptomatic fibrosis or pneumonitis (severe cough), low grade fever, patchy radiographic changes; grade 3 as severe symptomatic fibrosis or pneumonitis, dense radiographic changes and grade 4 as severe respiratory insufficiencies, oxygen required of assisted ventilation. Late cardiac toxicity was defined grade 1 as minimal enlargement of cardiosilhoutte (ECS), grade 2 as ECS without pulmonary congestion, grade 3 as ECS pulmonary congestion and grade 4 as ECS with frank pulmonary oedema. All late effects assessment scores were dichotomised as none/mild versus moderate/marked effects.

Late-term Effects of Hypofractionated Chest Wall and Regional Nodal Irradiation in Patients With Breast Cancer

Dept. of Radiation Oncology, PGIMER, Chandigarh

Late fibrosis was defined grade 1 as barely palpable firmness, grade 2 as definite increased firmness and grade 3 as marked firmness of the chest wall.

Telangiectasia was defined grade 1 as \<1cm2, grade 2 as 1 cm2-4 cm2 and grade 3 as \>4 cm2 area of chest wall

Lymphedema was graded by measuring arm circumference 10cm above and below the medial epicondyle of humerus . For lymphedema and shoulder function, the treated side was compared with the untreated opposite side as a reference. Lymphedema was classified as none, mild, moderate and marked if there was no difference, 0.5-2cm, 2.1-3cm and \>3cm difference, respectively in the circumference of the affected and normal arm.

Late lung toxicity was defined grade 1 as asymptomatic or mild symptoms of dry cough,slight radiographic changes; grade 2 as moderate symptomatic fibrosis or pneumonitis (severe cough), low grade fever, patchy radiographic changes; grade 3 as severe symptomatic fibrosis or pneumonitis, dense radiographic changes and grade 4 as severe respiratory insufficiencies, oxygen required of assisted ventilation.

Late cardiac toxicity was defined grade 1 as minimal enlargement of cardiosilhoutte (ECS), grade 2 as ECS without pulmonary congestion, grade 3 as ECS pulmonary congestion and grade 4 as ECS with frank pulmonary oedema. All late effects assessment scores were dichotomised as none/mild versus moderate/marked effects.

Post Graduate Institute of Medical Education and Research, Chandigarh

Additional Professor

This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.

IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.

Multi-Beam Intensity-Modulated Radiation Therapy

MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.

BreastQ questionnaire-

Simon Powell, MD

This study is being performed to understand the safety of a new radiation treatment called "Multi-Beam Intensity Modulated Radiation Therapy" ( IMRT). Currently, the standard way of giving radiation is with "simplified" IMRT, which uses only 2 beams of radiation. "Multi-beam" IMRT works by using 6-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the breast, chest wall, and the lymph nodes. At the same time, multi-beam IMRT may allow the dose to the heart, lungs, and nearby tissue to be lowered, especially when the internal mammary lymph nodes need to be targeted by radiation.

Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer

Pilot Study of Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer Patients Requiring Treatment of the Internal Mammary Lymph Nodes

The purpose of this pilot study is to assess the feasibility of utilizing multi-beam IMRT in the adjuvant treatment of the breast and regional lymph nodes of women with node-positive breast cancer requiring coverage of the internal mammary lymph nodes. A feasibility rate of at least 90% is required, ie, treatment can be successfully planned and delivered for at least 90% of the patients.

Toxicity evaluated by utilizing the CTCAE version 3.0 grading system.

The radiation oncologist will score late subcutaneous fibrosis at 5-7 months following CoT, utilizing the CTCAE version 3.0 grading system.

Participants FEV1 (forced expiratory volume in 1 second) measured at baseline

Severity of radiation pneumonitis (RP) measured by FEV1 Z (forced expiratory volume in 1 second) and FVC Z (forced vital capacity) for participants at baseline

Participant Pulmonary Function Test/PFTs and mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy

Mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy. The questionnaire focuses on the presence of dyspnea, severity of dyspnea, presence of cough, and general health and generates a "CAP score." Low values indicate more severe symptoms. Means will be taken of total scores, from 1-100.

Severity of radiation pneumonitis (RP) measured by FEV1 Z (forced expiratory volume in 1 second) and FVC Z (forced vital capacity) for participants 6 months from baseline.

Mean Community-Acquired Pneumonia/CAP scores will be taken at 6 months post radiation therapy. The questionnaire focuses on the presence of dyspnea, severity of dyspnea, presence of cough, and general health and generates a "CAP score." Low values indicate more severe symptoms. Means will be taken of total scores, from 1-100.

Median follow-up period of the enrolled cohort

Memorial Sloan Kettering Cancer Center

This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.

Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.

BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.

Radiation Therapy Via Multi-beam IMRT

Age, Continuous

Ethnicity (NIH/OMB)

United States

Region of Enrollment

1 participant is male. A deviation to treat him per protocol was submitted and approved because using multi-beam radiation as part of the study was the best way to treat the study participant's breast cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation	NCT05870241	Post Mastectomy...	Ga-As Laser Microcurrent El... traditional the...	40 Years - 55 Years	Cairo University
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema	NCT02020837	Lymphedema Post Mastectomy	Lymphaticovenou...	18 Years - 70 Years	University of Arkansas
Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation	NCT05870241	Post Mastectomy...	Ga-As Laser Microcurrent El... traditional the...	40 Years - 55 Years	Cairo University
Late-term Effects of Hypofractionated Chest Wall and Regional Nodal Irradiation in Patients With Breast Cancer	NCT04175821	Late Effects of...	Hypofractionate...	18 Years - 75 Years	PGIMER
Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer	NCT01127373	Breast Cancer	Multi-Beam Inte... BreastQ questio...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for post mastectomy