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Report for Clinical Trial NCT02522988

Developed by Shray Alag, 2020.
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 Labels: 2

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:
HP:0012378: Fatigue
Genes 404
IYD ATP7A TLR3 TET2 PAX8 ERCC4 COL1A1 TNFSF15 MLX SCNN1A TCF4 GPR101 TAZ OPTN TWNK RRM2B MC2R TSR2 MYH7 IL12A TRNL1 TBX19 SDHC BCL10 PTPN3 PPARGC1A MST1 MALT1 SLC2A10 AIP IL12A-AS1 CDH23 ERAP1 RPS20 SQSTM1 CFI FOXP1 UNC93B1 RPL15 SCN2A ND1 HBA1 COL1A2 MEN1 NAB2 RPS10 HFE COX2 GCH1 UBQLN2 KRAS PALB2 SEMA4A FUS PAX8 ACADM DYSF PDE11A IGH LHX3 TG MATR3 SLC3A1 NR3C1 HELLPAR TRNQ SLC25A26 VHL PROP1 RPL35 CD46 MLH1 TSHR MEFV CHRND FIG4 ABL1 SDHD IL12A KIF23 HLA-DRB1 TRNS1 RPL26 CHMP2B FGFR1 STAT3 POLG2 TSC1 ALB AGK TET2 TNPO3 SLC25A4 ATXN2 MET GLA HBA2 ARMC5 SLC25A11 BIRC3 IRF2BP2 RPS19 RPL35A GCK HLA-DPA1 PDE8B STAT4 PIGA COL5A2 PRRT2 NNT BCOR ALAS2 PIEZO1 BRCA2 ATP13A2 VPS13A WAS SDHD NFKB2 SOX3 TGFBR2 RPS24 HMGCL SLC4A1 SH2B3 VCP COX1 TET2 GATA2 ZBTB16 NUMA1 DCTN1 TXNRD2 ND5 TAF15 CPT2 ND4 KCNN4 BCL6 TSHB XPA RPS27 RPS26 PTPN22 KIT STAT5B PON1 ERCC5 ALB FOXA2 XPC RPS28 AP2S1 MPL ELANE CCR1 PROP1 PRPH RPS7 RUNX1 ABCC2 HNF1A KIT TICAM1 SLC18A3 HLA-DRB1 POMGNT1 NABP1 TREM2 ATP13A2 HNF4A WIPF1 PHKG2 CDKN2A SCNN1B PFN1 FGF23 ND6 CTLA4 PRTN3 RARA TSHR SCNN1G C9ORF72 RPL27 CPT1A CCND1 HLA-B NLRC4 BRCA1 SOD1 GLT8D1 TRNF ANG GLE1 EPAS1 NEK1 PIGT SLC26A4 NLRP3 SLC18A2 RPL11 ATRX HAVCR2 KLRC4 NPM1 GLI2 TK2 LRRC8A PRKAR1A RPS29 MRAP NLRP3 FIP1L1 USP8 KIF1B TWNK PML SCN8A SERPINA6 VHL TBL1XR1 CD79B LBR JAK2 SMAD3 MDH2 ARMC5 MMADHC RPL18 TARDBP DNM1L PODXL SOX2 MMACHC JAK2 ARNT2 SLC40A1 BCL2 STAT6 CAV3 POU2AF1 CD79A UNC13A TBK1 SDHC BCR ERCC3 RPL5 PDGFRA BLNK TCF3 TPO CFAP410 IGH HLA-B HLA-DPB1 VAPB INSR DLST ERCC2 C1QBP DBH CCNF RPS17 TMEM127 STAR IL12RB1 IRF5 C4A PROKR2 BMPR1A UBAC2 CALR PTPN22 NKX2-5 TSC2 RPL31 IL23R PLEC PMS1 CPT2 NKX2-1 ERBB4 COQ2 FOXE1 BTK MSH6 EPOR STEAP3 PIK3CA KCNQ3 PIK3R1 KCNE1 SLC12A3 POLG RET VHL KCNQ2 SDHB DDB2 SYNJ1 TLR4 KCNQ1 PROP1 CDH23 RPS15A EPCAM SDHB KRAS SDHAF2 HESX1 SLC5A5 TRAF3 DUOX2 IL10 ATM GNAS IGH TNXB PREPL SDHA PMS2 GBA SMAD4 ADA2 AIP MORC2 POU1F1 HLA-B CDC73 DUOXA2 TRNW COX3 LHX4 MYD88 TFR2 COL5A1 BTNL2 NEFH TRNH OPA1 FH IKZF1 PHKA2 DAO NLRC4 GPR35 SLC11A1 PON3 CCDC78 DNAJC6 HESX1 TRNS2 NR3C1 SMAD3 PNPLA8 TP53 PGM1 CDH23 CHCHD10 PRKACA HESX1 FAN1 CDC73 IL12B MAX POU1F1 FAS MEN1 HNRNPA1 PSTPIP1 PALLD TBK1 CTNNB1 NAGS CCND1 EPHA4 OTX2 SDHB OTX2 MSH2 PON2 JAK2 MMEL1 RET SDHA PRKAR1A GATA1 SOX3 IGHM MLH3 CFH FTL IGLL1 ANXA11 SPIB LHX4 TET2 MPL DMD SLC26A4 TRNK
Protein Mutations 3
T25W V158M V18M
SNP 0