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Table 1 Study Characteristics of Clinical Trials focused on management of Cancer Cachexia (2005–2016)

From: Pharmacological management of cachexia in adult cancer patients: a systematic review of clinical trials

Author, year, Study design Number of patients Cancer type Definition of cachexia Intervention Study duration Outcome measures Results1 (Weight) (Anorexia-Cachexia Score) (LBM) Results 2 (Appetite) Results 3 (Functioning) Results 4 (QOL-indicators) Survival Attrition/Completion Rate (%)
Group 1: Appetite Stimulants
 Strasser (2006) [22] RCT 243 Multiple ≥5% loss of body weight Arm1: CE Arm2: THC Arm3: PL 6 weeks Appetite (VAS) QOL (EORTC QLQ-C30) Body Weight No differences on body weight or or Anorexia-Cachexia EORTC QLQ-C30 scores (p = NA) No differences in appetite (VAS) scores between 3 groups (p = 0.46 and 0.95 respectively) No significant differences on physical, role, emotional, cognitive, and social functioning No differences in QOL indicators (p = 0.80 and 0.43 respectively) N/A 68
 Del Fabbro (2013) [24] RCT 48 Lung/GI ≥5% loss of body weight Arm1: Melatonin Arm2: Placebo 28 days Appetite change (ESAS) Body weight FACIT-F, Functional Assessment for Chronic Illness Therapy–Fatigue NS (p = 0.17) NS (p = 0.8) No significant difference on FACIT Scale (p = 0.65) No differences in scores on depression, wellbeing, pain and insomnia N/A 66
 Garcia (2015) [25] RCT 82 Multiple (mostly colon and lung) ≥5% loss of body weight Arm1: Anamorelin (50 mg) Arm2: Placebo 12 weeks LBM Handgrip strength ASAS score Improvement in both lean body mass (p = 0.0006) and appendicular body mass (p = 0.006) in anamorelin as compared to placebo. No differences in fat mass. Non-significant improvement (p = 0.36) Handgrip Strength improved in A group as compared to P group (p = 0.014) ASAS score improved in Anamorelin as compared to Placebo Group (p = 0.03) N/A 56
 Takayama (2016) [26] RCT 181 NSCLC ≥5% loss of body weight Arm1: Anamorelin (50 mg) Arm2: Anamorelin (100 mg) Arm3: Placebo 12 weeks LBM Handgrip strength QOL-ACD Improved weight in anamorelin 50 and 100 mg (p = 0.02 and 0.0002) respectively as compared to placebo. Improvement in lean body mass (LBM) in both groups (P=NS) Significant improvement in QOL-ACD appetite score for Anamorelin 100 mg as compared to placebo (p = 0.03) No differences in handgrip strength across all groups. (p = NS) Significant improvement in QOL-ACD total score in Anamorelin 100 mg as compared to placebo (p = 0.01) NS (=0.08, for 100 mg, =0.70 for 50 mg) 96
 Temel (2016) [27] RCT ROMANA1: 484 ROMANA2: 495 NSCLC ≥5% loss of body weight or BMI < 20Kg/m2 Arm1: Anamorelin (100 mg) Arm2: Placebo 3 months LBM Handgrip strength Anorexia-cachexia score ROMANA1 Arm1: + 0.99 kg Arm2: -0.47 kg P = < 0.0001 ROMANA2 Arm1:+ 0.65 kg Arm2:-0.98 kg P = < 0.0001 N/A ROMANA1 Arm1:-1.10 kg Arm2:=1.58 kg P = 0.15 ROMANA2 Arm1:-1.49 kg Arm2:-0.95 kg P = 0.65 ROMANA1 Arm1:4.12 Arm2:1.92 P = 0.0004 ROMANA2 Arm1:3.48 Arm2:1.34 P = 0.0016 NS (p = 0.47) 85
 Katakami (2018) [29] RCT 172 NSCLC ≥5% loss of body weight Arm 1: Anamorelin (100 mg) Arm 2: Placebo 3 months LBM (DEXA) Body weight Appetite Handgrip Strengh (Dynamometer) QOL (QOL-ACD) Arm 1: + 1.06 kg Arm 2: −0.50 kg P < 0.0001 Arm 1: + 0.7 Arm 2: + 0.3 P = 0.0005 NS (p = 0.08) Significant improvement in QOL in Arm 1 vs Arm 2(p = 0.02) NS (p = 0.37) 68
 Turcott (2018) [23] RCT 47 NSCLC Based on AC/S of the Functional Assessment of Anorexia Cachexia Therapy (FAACT) tool Arm 1: Nalibone (0.5 mg) Arm 2: Placebo 2 weeks Anorexia (FAACT) Appetite (VAS) QOL (EORTC-QOL-C30) No difference (p = 0.72) No difference (p = 0.21) N/A NS NA 70
Group 2: Cytokine Modulators
 Jatoi (2007) [32] RCT 63 Multiple (mostly lung and GI, exclude brain tumors) 1.Weight loss (> 2.27 kg in 2 months) 2. Caloric intake< 20 cal/Kg of bw/day Arm1: Etanercept 25 mg subcutaneous twice wkly Arm2: placebo 24 weeks 1. > 10% non-fluid weight gain from baseline 2. Appetite Arm1: (0%) Arm2: (0%) (p = 0.35) Appetite: (p = 0.87) N/A NS (p = NA) NS (p = 0.82) 95
 Jatoi (2010) [33] RCT 61 NSCLC Age ≥ 65 years If < 65 years ECOG PS of 2 Weekly docetaxel+ Arm1: Infliximab 5 mg/kg IV on day 1 and weeks 1, 3, 5 Arm2: placebo 8 weeks Non-fluid weight gain≥10% of baseline weight Arm1 (0%) Arm2 (0%) NS (p = 0.17) N/A N/A NS (p = NA) NS (p = 0.88) 65
 Gordon (2005) [34] RCT 50 Inoperable Pancreatic cancer > 10% weight loss over 6 months Arm1: Thalidomide Arm2: Placebo 24 weeks 1. Weight change(4wks) 2. Muscle mass 3. grip strength 4.QOL 5. Survival Arm1:(+ 0.37Kg) Arm2:(−2.2Kg) (p = 0.005) N/A Grip strength Arm1:-0.88 Arm2:-1.00 (p = 0.9) QOL: No difference (p = NA NS (p = 0.45) 66
 Yennurajalingam (2012) [35] RCT 31 Multiple (Mostly GI, GU) ≥5% loss of body weight Arm1: Thalidomide Arm2: Placebo 2 weeks Symptom assessment Functional assessment NS (p = NA) NS (p = NA) N/A NS (p = NA) N/A 60
 Mehrzad (2016) [36] RCT 70 Multiple ≥5% loss of body weight Arm1: Pentoxifylline Arm2: Placebo 2 months Body weight QOL Arm1: Decreased Arm2: Decreased (p = 0.80) N/A N/A Arm1: Decreased Arm2: Decreased (P = 0.037) N/A 91
Group 3: Anabolic Agents
 Lundholm (2007) [37] RCT 138 GI 1. Weight loss (2–3% of referral weight) 2.Albumin< 36 g/L Arm1:Insulin (0.11+/−0.05 units/kg/d) + BSC Arm2:BAS (no placebo) Variable 1. Body composition 2. Physical activity 3. QOL NS (p = NA) NS (p = NA) NS (p = NA) NS (p = NA) Significant Arm1: 181 days Arm2:128 days P < 0.03 NA
 Dobs (2013) [38] RCT 159 Multiple (Mostly lung, colorectal) ≥2% loss of body weight Arm1: Enobosarm 1 mg Arm2: Enobsoarm 3 mg Arm3: Placebo 113 days LBM Physical activity (Stair climb time) QOL (FAACT) Arm1: Increased (p = 0.0012) Arm2: Increased (p = 0.046) Arm3: No change (p = 0.88) N/A Arm1:Improved(p = 0.0019) Arm2: Improved(p = 0.0065) Arm3: No change (p = 0.11) Arm1: (P = 0.007) Arm2: (p = 0.14) Arm3: (p-0.41) NS 63
Group 4: Combination Agents
 Wen (2012) [41] RCT 102 Multiple (Mostly lung, gastric) ≥5% loss of body weight Arm1:MA + thalidomide Arm2: MA 8 weeks Body weight Fatigue QOL Grip strength NS (=p = 0.05) NS (p = 0.12) NS (p = 0.05) Sig (p < 0.01) N/A 91
 Kanat (2013) [42] RCT 62 Multiple ≥5% loss of body weight Arm1:MA + Meloxicam Arm2:MA + Meloxicam+EPA Arm3: Meloxicam+EPA 3 months LBM BMI QOL NS (p = 0.61) N/A N/A NS (p = NA) N/A TBD
 Mantovani (2010) [43] RCT 332 Multiple (Mostly lung, breast, colon) Weight loss > 5% Arm1: MPA or MA Arm2: EPA supplement Arm3: L-Carnitine Arm4: Thalidomide Arm5: combination 4 months 1.LBM (DEXA) Grip strength QOL (EQ-5D) Arm3:(−0.7 kg) Arm4:(−0.8 kg) Arm5: (2.1 kg) (P .007) Significant improvement in arm 5.(p = 0.0037) NS (p = NA) NS (p = NA) NS (p = NA) 100
 Madeddu (2012) [44] RCT 60 Multiple (Mostly head & neck, lung) ≥5% loss of body weight Arm1: L-Carnitine + Celecoxib Arm2: L-Carnitine + Celecoxib + MA 4 months LBM Physical activity NS(p = 0.33) NS (=0.25) NS(p = 0.08) NS (p = 0.51) NS (p = NA) 93
 Kouchaki (2018) [45] RCT 60 GI > = 5% loss of body weight, 2 years of life expectancy Arm 1: Celecoxib+MA Arm 2: MA 2 months Body Weight (> = 5%) Appetite (VAS) Grip strength QOL (EORCT QOL-C30) NS (0.83) NS (p = 0.05) NS (p = 0.36) NS (p = 0.25) NS (p = NA) 37
  1. CE Cannabis extract, THC Tetrahydrocannabinol, PL Placebo, VAS Visual analog scale, MPA Medroxyprogesterone acetate, MA Megesterol acetate, RCT Randomized controlled trial, QOL Quality of life, NS Not significant, N/A Not available, ESAS Edmonton symptom assessment scale, FAACT Quality of life by the functional assessment of anorexia/cachexia therapy (FAACT) questionnaire, LBM Lean body mass, ASAS Anderson symptom assessment scale, NSCLC Non-small cell lung cancer, BAS Best available support, QOL-ACD Quality of life-anti cancer drugs