SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02522988

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors

The purpose of this randomized-controlled, crossover pilot trial is to evaluate the feasibility, acceptability and effects of a non-deceptive (open-label) administration of placebo pills for treating cancer related fatigue (CRF). If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses.

NCT02522988 Fatigue
MeSH: Fatigue
HPO: Fatigue

1 Interventions

Name: Open-label placebo intervention

Description: An open-label placebo intervention is an administered placebo that is fully disclosed to participants. It is delivered with a script that tells participants they are receiving placebos; placebos have been found to have effects that are comparable to some clinical treatments; placebos work because of conditioning, expectancies, interactions with care team and biochemical factors (i.e., dopamine, endorphins). Participants are given placebos to take for a 3-week period and will not receive placebos for a 4-week period (including a one-week washout period).

Type: Behavioral

Group 1a Group 2b


Primary Outcomes

Description: Unit of measure: number of enrollees / number of eligible participants as a measure of feasibility.

Measure: Enrollment Rate

Time: End of Study (7 weeks)

Description: Unit of measure: number of accrued participants / recruitment goal (80); odds ration of expected time-to-first participant/ actual time-to-first patient enrollment.

Measure: Accrual Rate as a Measure of Feasibility

Time: End of Study (7 weeks)

Description: Unit of measure: number of placebos taken / number prescribed (84)

Measure: Adherence Rate as a Measure of Feasibility

Time: End of Study (7 weeks)

Description: Unit of measure: number eligible for enrollment / number screened

Measure: Eligibility as a measure of Feasibility

Time: End of Study (7 weeks)

Description: Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled

Measure: Retention as a measure of Acceptability

Time: End of Study (7 weeks)

Secondary Outcomes

Description: Units of measure: units on a scale using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) instrument. 30-questions measure the global, somatic, affective, behavioral and cognitive manifestations of fatigue. Scale for items = 0 (not at all) - 4 (extremely)

Measure: Measure of fatigue manifestation

Time: Baseline, 3 weeks, 4 weeks and 7 weeks

Description: Unit of measure: units on a scale using the Medical Outcomes Study 36-Item Short Form (MOS-36) instrument. The 36-item instrument measures the impact of fatigue on vitality, physical functioning, emotional functioning, social functioning and mental health. Scale for items = 1 (limited a lot) - 3 (Not limited at all)

Measure: Measurement of impact of fatigue on quality of life

Time: Baseline, 3 weeks, 4 weeks and 7 weeks

Description: Unit of measure: units on a scale using the FACT-Fatigue instrument; scale for impact is 0 = not at all; 10 = very much.

Measure: Measurement of the impact of fatigue on physical function

Time: Baseline, 3 weeks, 4 weeks and 7 weeks

Description: Units of measure: units on a scale using the Fatigue Symptom Inventory (FSI) instrument. Scale = 0 (no fatigue / no interference) to 10 (extreme fatigue / interference)

Measure: Measurement of fatigue severity

Time: Baseline, 3 weeks, 4 weeks and 7 weeks

Other Outcomes

Description: Investigators will collect and store saliva samples so, should significant OLPI effects be obtained, we can evaluate whether a potential biomarker (COMT Val158Met variant) associates with placebo responsiveness.

Measure: Test for the presence of a COMT Val158Met/Val or Val/Val variant gene

Time: Baseline

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There are 2 SNPs

SNPs


1 V158M

Test for the presence of a COMT Val158Met/Val or Val/Val variant gene. --- Val158Met ---

Investigators will collect and store saliva samples so, should significant OLPI effects be obtained, we can evaluate whether a potential biomarker (COMT Val158Met variant) associates with placebo responsiveness.. Inclusion Criteria: - Clinical diagnosis of Stage II - IV cancer; - Completed primary treatment 6months to 10 years; - Report ≥4 (moderate fatigue) on a 0-10 fatigue severity rating scale; - Agree not to change any medications or treatments during the study; - Willingness to make 4 clinical site visits over the course of the 49-day study. --- Val158Met ---


2 V18M

If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses. --- Val18Met ---



HPO Nodes


HPO:
Fatigue
Genes 327
VAPB SOX2 IL10 SOX3 CFH CDKN2A HFE TPO TET2 MYD88 TSR2 IL12A EPOR IL12B IL12RB1 RPL26 RPL27 MYH7 ERBB4 CHCHD10 ERCC2 RPL35A ERCC3 ERCC4 ZBTB16 ABL1 ERCC5 PRTN3 ATP7A SPIB ATRX HLA-B PDGFRA ERAP1 HLA-DPA1 HLA-DPB1 HLA-DRB1 SLC26A4 MAX MATR3 KIF1B RPS7 INSR RPS10 MC2R GATA1 GATA2 BLNK RPS15A GBA CDH23 DAO RPS17 PTPN22 IRF5 RPS19 IKZF1 RPS20 TSC1 TSC2 CCND1 GCH1 HMGCL CD46 BCL2 TSHB DBH GCK RPS24 TSHR SLC25A26 RPS26 RPS27 RPS28 RPS29 BCL6 GPR101 MDH2 PFN1 DYSF COQ2 HNF4A BCR DNAJC6 DCTN1 ADA2 HNRNPA1 DDB2 KLRC4 MMADHC MEFV STAR NAGS HESX1 NLRC4 PGM1 STAT4 CHRND STAT5B HELLPAR MEN1 JAK2 SLC2A10 NEFH MET PPARGC1A MALT1 NEK1 PTPN3 BMPR1A AP2S1 GLA PIGA BRCA1 BRCA2 SYNJ1 PROKR2 SDHAF2 ATXN2 FIG4 PAX8 PIK3CA GLE1 SQSTM1 PIK3R1 GLI2 SCN2A BTK NFKB2 ARNT2 CCDC78 SCN8A VPS13A SCNN1A SCNN1B C1QBP MLH1 SCNN1G KCNQ2 FIP1L1 KCNQ3 CCR1 C4A BCL10 ALAS2 FGFR1 ALB CDC73 GNAS SEMA4A PLEC ABCC2 DMD FH KIT TNFSF15 CFAP410 IL23R SDHA TAZ SDHB SDHC VCP SDHD PML PDE11A COL1A1 DUOXA2 FOXE1 MPL PMS1 VHL KRAS NPM1 COL5A1 COL5A2 TCF4 HNF1A TCF3 PMS2 KIF23 UBQLN2 RARA ANG LHX4 WAS WIPF1 MLX SLC25A4 SH2B3 CALR GPR35 PODXL RRM2B POLG ANXA11 NUMA1 IYD PON1 PON2 PON3 POMGNT1 POU1F1 BIRC3 DUOX2 POU2AF1 DNM1L TWNK XPA MSH2 XPC LHX3 AIP LBR CAV3 PSTPIP1 TXNRD2 RET NABP1 NR3C1 RUNX1 PRRT2 CPT1A CPT2 CFI FAS TMEM127 TBL1XR1 ATP13A2 PREPL SLC40A1 OPA1 PALB2 NLRP3 MMACHC SLC3A1 CHMP2B TFR2 FAN1 TG SLC5A5 CCNF HAVCR2 MST1 TBX19 TGFBR2 FGF23 TARDBP MSH6 USP8 PIGT OPTN MLH3 OTX2 MMEL1 SLC11A1 SLC12A3 COX1 COX2 COX3 IGH NKX2-1 IL12A-AS1 SLC18A2 SLC18A3 TK2 PDE8B IGHM BTNL2 TBK1 MRAP ND1 ARMC5 ND4 TLR4 ND5 ND6 PRKACA TREM2 PRKAR1A AGK LRRC8A ELANE STEAP3 NKX2-5 CD79A CD79B UBAC2 FOXP1 TRNF PNPLA8 FTL TRNH TAF15 CTLA4 TRNK IGLL1 TRNL1 ATM RPL35 FUS CTNNB1 TRNQ TRNS1 HBA1 TRNS2 C9ORF72 HBA2 POLG2 TRNW EPCAM NNT TNXB RPL5 PALLD TNPO3 UNC13A TP53 RPL11 SOD1 SMAD3 SMAD4 PROP1 RPL15 EPHA4 RPL18 PRPH