The program comprises the practice of resistance exercises for the main muscular groups, with free weights and with their own body weight against the action of gravity, the proposal consists of 3 weekly sessions, for 8 consecutive weeks.

Acromegaly

Muscle Dysfunction

Physical Activity

Exercise

Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit.

Physical activity

Centro universitário augusto motta

Rehabilitation Program in Patients With Acromegaly

Impact of a Physical Rehabilitation Program on the Quality of Life of Patients With Acromegaly: a Non-randomized Clinical Trial.

Peripheral muscle strength and fatigue strength will be evaluated using an EMG -810 surface electromyograph and a DIN_TRO traction dynamometer. For the strength test, the muscle evaluated will be the femoral quadriceps, the patient will be instructed to perform the knee extension, with the highest possible isometric force. Your positioning will be seated with your hands crossed over the chest, with the upright trunk adjusted by the backrest in order to allow the angle of 90 ° for hip flexion. For analysis of fatigue strength, surface electromyography of the medial vastus muscle (VM) of the dominant lower limb will be used through the 8-channel surface electromyograph from the gross signal. The endurance test consists of a contraction sustained for 60 seconds using 50% of the highest MIVM obtained in the strength test.

For the execution of the TC6M, the patient will be previously oriented to use sneakers and comfortable clothing. Later it will be positioned in a corridor of 30 meters, demarcated every 3 meters and oriented to walk as fast as possible, but without running, for a total period of 6 minutes. Peripheral saturation of O2 (SpO2), heart rate (HR), modified Borg scale, blood pressure (BP) during the test will be checked. There will be two tests with a 30 minute interval between them. The distance selected will be the patient's best performance. This is based on reducing the learning effect. Subsequently, the data found will be associated with the forecast of Britto et al. (2013) according to age, height and body weight of each individual.

The Acromegaly Quality of Life Questionnaire (AcroQol) is a specific, simple and valid instrument for assessing quality of life in people suffering from acromegaly aged 18-70 years. It can be used in two different fields: in clinical trials of new drugs as well as in the follow-up of patients in clinical practice. This is particularly useful in evaluating the effects of intervention or treatment. The questionnaire is one-dimensional and contains 22 items divided into two scales: one that evaluates physical aspects (eight items) and another that evaluates the psychological aspects (14 items). The latter is also divided into two sub-scales: one evaluates physical appearance and another evaluates the impact of the disease on the patient's personal relationships (seven items each). The score is given from 1 to 5 where, the lower the score, the worse the quality of life.

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale was developed for individuals with chronic diseases to evaluate health-related quality of life, treating fatigue as a multidimensional concept. This scale has been applied in different groups of patients with different types of dysfunctions. FACIT-F is a specific scale of evaluation of fatigue that has good representation of the individual's frame, considered as an instrument of easy application, and its use authorized by the author of the same. It will be answered by the researcher himself, with 13 questions ranging from 0 to 4, where the higher the score, the less fatigue. Your score goes from 0 to 52.

The Lower Extremity Functional Scale (LEFS) is a self-administered questionnaire for orthopedic assessment of lower limb integrity. It was developed according to the concepts of functionality and disability of the World Health Organization (WHO). This scale comprises 20 questions and each has a score that varies between the minimum of zero (extremely difficult) and the maximum of four points (without difficulty). The sum of all items can generate a maximum total of 80 points. Such a level of punctuation suggests a normal functional state, that is, the higher the value obtained, the higher the level of functionality of the individual. The LEFS scale is easy to apply and can be used at different levels of functionality and disability related to the lower limbs. It is usually used in initial evaluations, during treatment and thereafter, in order to establish new therapeutic goals for patients.

Body weight and height of patients will be measured using a Filizola® mechanical scale with a maximum capacity of 150 kilograms and a sensitivity of 100 grams and a stadiometer. Body mass index (BMI) will be calculated by dividing body mass by height squared.

Evaluates the perception of the degree of effort, performed during the exercise. Currently, it is used in the modified form described with a score varying with scores between 0 where the level of perception of dyspnea (fatigue) or muscle fatigue is "none" until 10 where the level of perception of dyspnea (fatigue) or muscle fatigue is " maximum".

Data available in scientific environment.

Centro Universitário Augusto Motta

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

After a physical therapy evaluation, the patient underwent a booklet-guided physical exercise program that lasted two months (3 times per week with a duration of 60 minutes per session). Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit. The patient was evaluated at 3 different timepoints (baseline, after 8 weeks of training, and after a 4-week washout period with no treatment); thus, he served as his own control. The physiotherapist contacted the patient by phone weekly to follow the progression of the treatment. Throughout the application of the protocol, the patient regularly maintained his follow-up visits with the multidisciplinary team. Moreover, there was no change in pharmacological treatment throughout this period.

In a 3 + 3 cohort design, three patients are initially enrolled into a given dose cohort. If there is no DLT observed in any of the first three subjects, the trial proceeds with enrolling additional subjects into the next higher dose cohort. If one subject develops a DLT at a specific dose, an additional three subjects are enrolled into that same dose cohort. Development of DLTs in >1 of 6 subjects in a specific dose cohort will determine the MTD and no further dose escalation is done.
Dose Level/TTI-101 (mg/kg/day) administered in divided doses every 12 hours 1/3.2 2/6.4 3/12.8 4/25.6 5/To be determined and approved through the amended protocol
At the end of the dose escalation phase of the study, the investigators will determine the characteristics of the patients who will be enrolled at the expansion phase of the study.

Breast Cancer

Head and Neck Squamous Cell Carcinoma

Non Small Cell Lung Cancer

Hepatocellular Cancer

Colorectal Cancer

Gastric Adenocarcinoma

Melanoma

Advanced Cancer

Patients in the first cohort are treated at dose level 1. Each cohort of a dose level will include at least 3 patients, who will be evaluated for at least one cycle (28-days). The next dose level will be determined after careful review of the tolerability and pharmacokinetics of the previous cohort. If the current dose is the lowest dose and the rule indicates dose de-escalation, we will treat the new patients at the lowest dose unless the number of DLTs reaches the elimination boundary, at which point we will terminate the trial for safety. If the current dose is the highest dose and the rule indicates dose escalation, we will treat the new patients at the highest dose.

TTI-101

The University of Texas MD Anderson Cancer Center

Oral STAT3 Inhibitor, TTI-101, in Patients With Advanced Cancers

Phase I Study of TTI-101, an Oral Inhibitor of Signal Transducer and Activator of Transcription (STAT) 3, in Patients With Advanced Cancers

To determine the maximum tolerated dose (MTD), dose-limiting toxicities, and tolerability of TTI-101 administered orally to patients with advanced breast cancer and other solid tumors. Dose-limiting toxicity is defined as a Grade 3 or above adverse event (using CTCAE v5.0) within the first treatment cycle (28-days).

Cmax(obs) will be determined by direct inspection of the plasma drug concentration versus time data point values.

Tmax(obs) will also be determined by direct inspection of the plasma drug concentration versus time data point values.

AUC(0-t) (where t = the time point for the last sample on the pharmacokinetic profile in which quantifiable drug was detected) will be estimated using linear or linear/log trapezoidal calculation.

Levels of pY-STAT3 measured using Luminex bead-based assays, without and with cytokine stimulation both before and after receiving TTI-101 will be measured. Changes in pY-STAT1 and pY-STAT3 over time will be assessed.

Levels of pY-STAT3 will be scored by percentage of positive cells and intensity of staining. Analyses will be at only two time points: before and after 28-day cycle.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).

Non-CR/Non-PD: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.

Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).

The best overall response is the best response recorded from the start of the study treatment until the end of treatment, taking into account any requirement for confirmation. The patient's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions.

Assess the association between STAT3 inhibition, fibrosis (if applicable), antitumor activity and survival outcomes after receiving TTI-101. Tissue and blood immune monitoring will be based on 2 biopsies. Association between biomarkers including pY-STAT3, PD1, and PD-L1 proteins expression by IHC, gene expression profiling, and antitumor efficacy and survival outcome of TTI-101 based on RECIST 1.1.

Tvardi Therapeutics, Incorporated

M.D. Anderson Cancer Center

All participants will be asked to take Lapatinib daily for a total of six months during the research study.

All participants will be asked to take Lapatinib daily for a total of six months during the research study.
Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.

Lapatinib

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Prolactin

Tumor volume will be assessed on MRI at 6 months on therapy and compared to baseline MRI.

All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.
Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.

Change in Tumor Volume

50% reduction in prolactin level measured monthly on 6 months therapy compared to baseline level.

Number of Participants With 50% Reduction in Prolactin Levels

Percent prolactin change from start of lapatinib to end of study participant participation

% Change in Prolactin From Baseline to Study End

Mean percent positive expression of EGFR and ErbB2 will be tested on pathologic tumor specimens from subjects treated with lapatinib

ErbB Receptor Expression

Overall Study

Odelia Cooper

Pituitary Adenomas

Prolactinomas

All participants will be asked to take Lapatinib daily for six months during the research study.

adenoma/tyrosine

Rehabilitation Program in Patients With Acromegaly

Oral STAT3 Inhibitor, TTI-101, in Patients With Advanced Cancers

Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy

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