Overview of NCI Overview of NCI Supported Fatigue Supported Fatigue

Trials Trials

Ann O’Mara, PhD, RN, Ann O’Mara, PhD, RN, FAAN FAAN

Objectives Objectives

1.1. Review NCI supported fatigue clinical Review NCI supported fatigue clinical trials funded throughtrials funded through

a)a) NCI Clinical Trials Program - CCOPNCI Clinical Trials Program - CCOP

b)b) Investigator-initiated projectsInvestigator-initiated projects

2.2. Highlight selected fatigue measures and Highlight selected fatigue measures and sample sizes sample sizes

Key Questions Key Questions

1.1. What are the trade-offs (lengthy vs. brief What are the trade-offs (lengthy vs. brief measures, complex vs. simple measures, complex vs. simple interventions) in conducting multi-site interventions) in conducting multi-site clinical trials?clinical trials?

2.2. Can multi-site trials target multiple Can multi-site trials target multiple components of fatigue? components of fatigue?

Community Clinical Oncology ProgramCommunity Clinical Oncology Program

What is a CCOP?What is a CCOP?

A Group of Community Hospitals and A Group of Community Hospitals and Physicians, each with a unique structurePhysicians, each with a unique structure

Funded by a Peer Reviewed Cooperative Funded by a Peer Reviewed Cooperative AgreementAgreement

Participate In NCI-approved Cancer Participate In NCI-approved Cancer Treatment, and Cancer Prevention and Treatment, and Cancer Prevention and Control Clinical TrialsControl Clinical Trials

Currently, 49 CCOPs and 14 Minority-Currently, 49 CCOPs and 14 Minority-Based CCOPsBased CCOPs

Community Clinical Oncology ProgramCommunity Clinical Oncology Program

What is a CCOP Research Base?What is a CCOP Research Base? An NCI-designated Cancer Center or Cooperative An NCI-designated Cancer Center or Cooperative

GroupGroup Funded by a Peer- Reviewed Cooperative Funded by a Peer- Reviewed Cooperative

AgreementAgreement Develop and Conduct Cancer Prevention and Develop and Conduct Cancer Prevention and

Control Clinical TrialsControl Clinical Trials Supports Development of Cancer Prevention Supports Development of Cancer Prevention

ScienceScience Currently, 13 Research BasesCurrently, 13 Research Bases

CALGB

Univ. of Rochester

COG

SWOG

NCCTG

GOG NSABP

Wake Forest University

ECOG

MD Anderson

RTOG

H. Lee Moffitt Cancer Center

Fox Chase Cancer Center

Research Bases (14)

Minority-Based CCOPs (14)

CCOP sites located throughout the US (49)

Symptoms Under Study in Trials Since 1995

SymptomSymptom Number of StudiesNumber of Studies

FatigueFatigue 1212

PainPain 1212

Hot FlashesHot Flashes 1111

Anorexia & Weight LossAnorexia & Weight Loss 1010

Nausea & VomitingNausea & Vomiting 99

Cognitive FunctionCognitive Function 88

MucositisMucositis 77

Quality of LifeQuality of Life 77

DiarrheaDiarrhea 66

OsteoporosisOsteoporosis 66

InfectionInfection 55

Prevention of Weight LossPrevention of Weight Loss 55

NeuropathyNeuropathy 55

Skin ToxicitiesSkin Toxicities 22

Hand & Foot SyndromeHand & Foot Syndrome 11

Others (e.g., Ascities, Depression, HRT, Sexual Others (e.g., Ascities, Depression, HRT, Sexual Functioning, Stress & Distress, etc…)Functioning, Stress & Distress, etc…)

2828

Fatigue Trials Conducted in the Fatigue Trials Conducted in the CCOP Network (1995-2007)CCOP Network (1995-2007)

ClassificationClassification Agent (# Agent (# of trials)of trials)

Sample Sample SizeSize

Fatigue Fatigue MeasureMeasure

ErythropoeticsErythropoetics Epoetin Alfa Epoetin Alfa (4)(4)

128 - 344128 - 344 QOL-LASA #1; QOL-LASA #1; BFI; FACT-An; BFI; FACT-An; Uniscale; FACT-FUniscale; FACT-F

CAMCAM American American Ginseng (1)Ginseng (1)

Levo- Levo- carnitine (1)carnitine (1)

Coenzyme Coenzyme Q10 (1)Q10 (1)

280280

352352

202202

BFI - SummaryBFI - Summary

#2 BFI – “usual”#2 BFI – “usual”

POMS-FPOMS-F

Fatigue Trials Conducted in the Fatigue Trials Conducted in the CCOP Network (1995-2007)CCOP Network (1995-2007)

ClassificationClassification Agent (# Agent (# of Trials)of Trials)

Sample Sample SizeSize

Fatigue Fatigue MeasureMeasure

PsychostimulantsPsychostimulants Methylpheni-Methylpheni-date (2)date (2)

Modafinil (1)Modafinil (1)

140; 160140; 160

837837

#2 BFI-‘usual’; #2 BFI-‘usual’; FACIT-FFACIT-F

#3 BFI – ‘worst’#3 BFI – ‘worst’

AntidepressantsAntidepressants Paroxetene Paroxetene (1)(1)

908908 #3 BFI – ‘worst’#3 BFI – ‘worst’

ResultsResults

Of the 11 trials, 4 published resultsOf the 11 trials, 4 published results All statistically negativeAll statistically negative Ginseng trial showed trendsGinseng trial showed trends

93 Studies

Investigator-Initiated (R01, R21) Investigator-Initiated (R01, R21) Fatigue Trials (2000-2007)Fatigue Trials (2000-2007)

45 Clinical Trials (Phase I-II)

CBT (17) CAM (15) Yoga, Acupuncture, Polarity Tx, Massage

Exercise (10) Pharmacologic (3) Methylphenidate, Pemoline, Venlafaxine,

Investigator-Initiated (R01, R21) Fatigue Investigator-Initiated (R01, R21) Fatigue Trials (2000-2007) – Examples of Trials (2000-2007) – Examples of

Measures UsedMeasures Used

CBT (17) CAM

(15)

Exercise (9)

Pharmacologic (3)

Piper FSPiper FS General General Fatigue ScaleFatigue Scale

SF-36 SF-36 (Vitality)(Vitality)FACIT-FFACIT-F

Piper FSPiper FS POMS-FPOMS-F

BFI (Summary)BFI (Summary) FACT-FFACT-F

Challenges to Conducting Clinical Challenges to Conducting Clinical Trials in NetworksTrials in Networks

InterventionsInterventions

1.1. Consistency of administration (agent vs. Consistency of administration (agent vs. behavioral intervention)behavioral intervention)

2. Compliance/adherence2. Compliance/adherence

3. Burden of administration3. Burden of administration

Challenges …Challenges …

Data CollectionData Collection

1. Consistency / Quality Control1. Consistency / Quality Control

2. Burden of collection2. Burden of collection

3. Missing Data3. Missing Data