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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 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 389
MPL RPL18 BIRC3 OPA1 JAK2 POU2AF1 TET2 ATRX POU1F1 SLC40A1 SQSTM1 PAX8 SCNN1B KIT SLC25A11 PON2 COQ2 PROKR2 PIGA IRF2BP2 OPTN HMGCL MMACHC HBA1 PODXL ERCC4 SLC2A10 PREPL RPL15 SCNN1G FOXA2 ADA2 RPS7 FUS SYNJ1 IL12B SLC11A1 DYSF MEN1 CDH23 BRCA2 HLA-B TRNF DMD PNPLA8 TBL1XR1 FIP1L1 LHX3 BCOR HLA-DPB1 ATP13A2 BCR TNXB DUOX2 IL10 COL5A1 GCK AIP BMPR1A IL12A-AS1 SPIB NABP1 MC2R CALR PHKG2 TSC1 MST1 FH RPL31 CCND1 TMEM127 ARMC5 RUNX1 DNAJC6 NUMA1 AIP RPS26 SDHA ELANE RPS27 IL12RB1 TCF3 ND5 MMEL1 VCP SMAD3 CDKN2A SOX2 MET VHL RPL11 BLNK IGH TXNRD2 TWNK FOXP1 HFE TRNH PMS2 SERPINA6 CD79B PROP1 FGFR1 IYD KCNQ2 NNT TSHR SLC26A4 TRNL1 STAT6 NKX2-1 POLG CPT1A ANG KRAS FGF23 CCDC78 VHL TSHR DBH POU1F1 VPS13A KRAS HNRNPA1 MSH2 CFAP410 PFN1 NLRP3 GATA2 ATM JAK2 TAZ C9ORF72 DUOXA2 TRNS1 SDHD CHCHD10 GATA1 NPM1 RPS20 USP8 MPL HAVCR2 COL1A1 TPO TREM2 PTPN22 FTL SCN2A KIT PRKAR1A COX1 HESX1 STAR RPL5 MRAP FOXE1 TRNW COX3 DAO GPR101 LHX4 RPL35 TSC2 IL12A KLRC4 KIF1B TGFBR2 BTK HLA-B NKX2-5 COX2 PDGFRA PAX8 RET RRM2B SMAD4 RPS19 ALB BTNL2 NLRC4 SDHA ERBB4 GLA PON3 GLE1 ZBTB16 NEK1 CDC73 ERCC3 PRTN3 TBX19 SLC5A5 STAT5B COL5A2 RPL35A OTX2 BCL10 CCR1 HNF1A PRPH TFR2 UBQLN2 OTX2 PALLD ND4 ERCC2 KCNQ3 MYH7 GNAS WIPF1 SLC26A4 HLA-B CPT2 FAN1 TWNK TRNQ GLT8D1 PROP1 HESX1 PML CTNNB1 SOD1 C1QBP TET2 RARA NR3C1 PDE11A CDH23 AP2S1 HELLPAR TNFSF15 ABCC2 TRNK CFH MDH2 RPL26 CHRND NLRC4 GPR35 HLA-DPA1 TET2 AGK SLC25A26 MYD88 INSR CAV3 SCNN1A SLC18A2 ATXN2 NR3C1 RPS10 BCL2 MATR3 GBA CFI NEFH PIGT ABL1 PRKACA SLC25A4 CD46 LBR CCNF MAX ANXA11 DNM1L IGHM FIG4 TARDBP VAPB TP53 IL12A IL23R MLH3 ND6 STEAP3 ARNT2 ATP13A2 TG ACADM DLST UNC13A PMS1 SDHB STAT3 TNPO3 RPS15A NAGS PTPN22 TK2 ATP7A MLH1 SDHAF2 POLG2 SDHC PON1 RPS29 ERAP1 SDHB MSH6 EPHA4 LHX4 GLI2 SLC18A3 DCTN1 IGH LRRC8A CHMP2B HESX1 TRNS2 BCL6 SDHC PRKAR1A HBA2 IGLL1 PIK3CA PSTPIP1 SCN8A TSHB CTLA4 CD79A PPARGC1A BRCA1 FAS RPL27 ARMC5 ALB SLC12A3 TAF15 WAS PGM1 HLA-DRB1 TLR4 PROP1 STAT4 ERCC5 IKZF1 RPS24 KCNQ1 SOX3 SH2B3 PLEC CCND1 TET2 CDC73 ND1 HNF4A TBK1 NAB2 PIK3R1 IGH PDE8B ALAS2 HLA-DRB1 MEN1 CDH23 EPCAM NLRP3 TCF4 PTPN3 SLC3A1 MMADHC SEMA4A XPA UBAC2 PRRT2 GCH1 C4A DDB2 TSR2 MALT1 PALB2 PHKA2 MEFV SOX3 RPS17 IRF5 POMGNT1 XPC CPT2 RPS28 EPOR KIF23 KCNE1 JAK2 SMAD3 NFKB2 MLX