There is a lack of robust evidence to assess the strength of other treatment options
Objectives Sarcopenia , defined as an age-associated loss of skeletal muscle function and muscle mass , occurs in approximately 6 - 22 % of older adults .
This paper presents evidence -based clinical practice guidelines for screening , diagnosis and management of sarcopenia from the task force of the International Conference on Sarcopenia and Frailty Research ( ICSFR ) .
Effects of enobosarm on muscle wasting and physical function in patients with cancer: a double-blind, randomised controlled phase 2 trial.
BACKGROUND Cancer-induced muscle wasting begins early in the course of a patient 's malignant disease , result ing in declining physical function and other detrimental clinical consequences . This r and omised , double-blind , placebo-controlled phase 2 trial assessed the efficacy and safety of enobosarm , a selective and rogen receptor modulator , in patients with cancer . METHODS We enrolled male ( > 45 years ) and female ( postmenopausal ) patients with cancer who were not obese and who had at least 2 % weight loss in the previous 6 months . Participants were r and omly assigned ( 1:1:1 ratio , by computer generated list , block size three , stratified by cancer type ) to receive once-daily oral enobosarm 1 mg , 3 mg , or placebo for up to 113 days at US and Argentinian oncology clinics . The sponsor , study personnel , and participants were masked to assignment . The primary endpoint was change in total lean body mass from baseline , assessed by dual-energy x-ray absorptiometry . Efficacy analyses were done only in patients who had a baseline and an on-treatment assessment in the protocol -specified window of within 10 days before baseline or first study drug , and within 10 days of day 113 or end of study ( evaluable efficacy population ) . Adverse events and other safety measurements were assessed in the intention-to-treat ( safety ) population . This trial is registered with Clinical Trials.gov , number NCT00467844 . FINDINGS Enrolment started on July 3 , 2007 , and the last patient completed the trial on Aug 1 , 2008 . 159 patients were analysed for safety ( placebo , n=52 ; enobosarm 1 mg , n=53 ; enobosarm 3 mg , n=54 ) . The evaluable efficacy population included 100 participants ( placebo , n=34 ; enobosarm 1 mg , n=32 ; enobosarm 3 mg , n=34 ) . Compared with baseline , significant increases in total lean body mass by day 113 or end of study were noted in both enobosarm groups ( enobosarm 1 mg median 1·5 kg , range -2·1 to 12·6 , p=0·0012 ; enodosarm 3 mg 1·0 kg , -4·8 to 11·5 , p=0·046 ) . Change in total lean body mass within the placebo group ( median 0·02 kg , range -5·8 to 6·7 ) was not significant ( p=0·88 ) . The most common serious adverse events were malignant neoplasm progression ( eight of 52 [ 15 % ] with placebo vs five of 53 [ 9 % ] with enobosarm 1 mg vs seven of 54 [ 13 % ] with enobosarm 3 mg ) , pneumonia ( two [ 4 % ] vs two [ 4 % ] vs three [ 6 % ] ) , and febrile neutropenia ( three [ 6%vs one [ 2 % ] vs none ) . None of these events were deemed related to study drug . INTERPRETATION Cancer cachexia is an unmet medical need and our data suggest that use of enobosarm might lead to improvements in lean body mass , without the toxic effects associated with and rogens and progestational agents . FUNDING GTx
There is a lack of robust evidence to assess the strength of other treatment options
Objectives Sarcopenia , defined as an age-associated loss of skeletal muscle function and muscle mass , occurs in approximately 6 - 22 % of older adults .
This paper presents evidence -based clinical practice guidelines for screening , diagnosis and management of sarcopenia from the task force of the International Conference on Sarcopenia and Frailty Research ( ICSFR ) .