Neoplasms

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Behaviors and Mental Disorders

Head and Neck Neoplasms

Deglutition Disorders

Quality of Life

Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months

Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy

Early swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting 2 weeks before radiotherapy

Expiratory/Inspiratory training: the training load is the maximum inspiratory/expiratory load defined according to patient tolerance. This load will be equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations (x 5 sessions), three times a day.

All sessions will be conducted under the supervision of an expert physiotherapist/swallowing therapist. The total duration of the training program is 6 months.

Early rehabilitation

Late swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting after completing radiotherapy

Late rehabilitation

Head and neck cancer has a negative impact in swallowing function and quality of life. Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies suggest that interventions should be initiated prior to RT sessions. This study aims to evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. The study pretends to establish a preventive rehabilitative program with the target of reducing RT side effects and improve patients' quality of life.

Head and neck cancer has a negative impact in swallowing function and quality of life. Although current diagnostic and therapeutic protocols try to preserve swallowing and speaking, acute or late dysphagia as well as a poor quality of life are frequent in these patients.

Some studies have reported an improvement in swallowing function after an exercise based intervention following radiation therapy (RT), regardless the need of concomitant chemotherapy (RT-QT). Other studies focus the interest in the use of prophylactic exercises to prevent or minimize post-swallowing dysfunction.

Patients receiving RT or RT-QT refer worsening of their quality of life, especially during the first days after treatment. One study suggests that rehabilitation prior to cancer treatment could potentially improve quality of life. However, this observation should be contrasted with a randomized study.

Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy

Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial

8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and \>6, aspiration

Security signs (tone of voice, coughing during or after eating, or desaturation of more than 3% compared to baseline pulse oximetry) assessed with the Volume Viscosity Swallow Test

Lingual Force: maximum isometric tongue pressure of three peak isometric tongue pressure scores assessed with the IOPI system.

Asociación Española contra el Cáncer

Parc de Salut Mar

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Breast cancer patients who underwent reconstructive surgery in samsung medical center from Jan 2017 to August 2017. Following early rehabilitation protocol, patients were educated to undergo a self-exercise program after short-term immobilization of 2 weeks.

Breast cancer patients who underwent reconstructive surgery in samsung medical center from May 2016 to Dec 2016. Following conventional protocol, patients were asked to immobilize their shoulder for more than 4 weeks and then undergo self-exercise program.

Ji Hye Hwang, MD, PhD

The purpose of the study is to find best post-operative rehabilitation protocol after total mastectomy and immediate reconstruction with tissue expander insertion. This study compared outcomes of two post-operative rehabilitation protocols ; "conventional protocol", which immobilized shoulder and upper arm motion for a month and "early rehabilitation protocol" with short-term immobilization period and early mobilization.

To prevent surgical site complications, surgeons use so-called "conventional protocol", which immobilizes shoulder and upper arm motion for a month after total mastectmoy and immediate reconstruction with tissue expander insertion. To improve shoulder mobility and QOL of patients, the investigators introduced a new and early rehabilitation protocol with short-term immobilization in Jan 2017.

The investigators retrospectively reviewed total 115 breast cancer patients who underwent reconstructive surgery from May 2016 to Aug 2017. Patients who did their reconstruction before Jan 2017 followed conventional protocol and immobilized their shoulder for more than 4 weeks. Patients who did their reconstruction after Jan 2017 were educated to undergo a self-exercise program after short-term immobilization of 2 weeks. The investigators reviewed shoulder mobility, pain, QOL and complications at postoperative 1 month and 2 month in both group of patients.

Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients

Early Rehabilitation After Total Mastectomy and Immediate Reconstruction With Tissue Expander Insertion in Breast Cancer Patients

Shoulder ROM was measured in flexion, abduction, external rotation and internal rotation in the affected upper limb at post-operative 1 month and 2month. Measurements were conducted by a physiatrist using a goniometer with patients in seated position.

A plastic surgeon reviewed the surgical site for hematoma, seroma, surgical site infection, implant rupture, extrusion of the implant, asymmetry/displacement of the implant and any other complications at post-operative 1 month and 2month.

The DASH questionnaire was used to assess shoulder function at postoperative 1 month and 2 month. Scores were transformed to a 0 to 100 scale.

The SF36 was used to assess QOL at postoperative 1 month and 2 month. The SF36 contains 8 sections measuring 8 domains of QOL: physical functioning (PF), role limitations because of physical health problems (RP), bodily pain (BP), general health perception (GH), vitality (VT), social functioning (SF), role limitations because of emotional problems (RE), and mental health (MH). The 8 sections are summarized into a two-component summary: the physical component summary (PCS; PF, RP, BP, GH and VT) and mental component summary (MCS; MH, RE, SF, VT and GH).

Self reported pain intensitiy at postoperative 1 month and 2 month. It scored 0-10 (0 = no pain; 10= pain as bad as can be)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy	NCT02900911	Cancer of Head ...	Early rehabilit... Late rehabilita...	18 Years -	Parc de Salut Mar
Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients	NCT03541161	Breast Cancer		-	Samsung Medical Center
Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients	NCT03541161	Breast Cancer		-	Samsung Medical Center

Spots Global Cancer Trial Database for early rehabilitation