Harnessing the Effect of an Open-Label Placebo on Fatigue... | NCT02452710

Studies
Harnessing the Effect of an Open-Label Placebo on Fatigue in Cancer Survivors

NCT02452710

Sponsor

Dana-Farber Cancer Institute

Status

Terminated

Last Update Posted

Dec 12, 2018Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Fatigue in Cancer Survivors

Interventions

Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study funding was completed.

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Feb 1, 2017Actual

Completion Date

Feb 1, 2017Actual

First Submitted Date

May 19, 2015

First Submission Date that Met QC Criteria

May 22, 2015

First Posted Date

May 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2018

Last Update Posted Date

Dec 12, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christopher Recklitis, Ph.D, Principal Investigator, Dana-Farber Cancer InstitutePrincipal Investigator

Lead Sponsor

Dana-Farber Cancer InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This research study is evaluating the usefulness of a placebo (a tablet with no active ingredients) on fatigue in cancer survivors.

Detailed Description

Fatigue can be a problem for some people after cancer treatment. In clinical trials, placebos (tablets with no active ingredients) have been shown to improve symptoms of some medical conditions including fatigue. This study is being done to test the usefulness of taking placebos for improving cancer-related fatigue. In this study, the investigators are testing whether symptoms of fatigue will improve when people know they are taking a tablet with no active ingredients.

This is a randomized study, which means the participant will be put into one of two groups. Because no one knows which of the study options is best, the participant will be 'randomized' into one of the two study groups. Randomization means that the participant will be put into a group by chance. It is like flipping a coin. Neither the participant nor the research doctor will choose what group he or she will be in. The participant will have an equal chance of being placed in each of the groups.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open-Label Placebo	Experimental	- Placebo Tablets-Twice a day for 3-4 weeks	Other: Placebo
NT-Control	No Intervention	- No Placebo Tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	Open-label placebo	Open-Label Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Fatigue on the Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) scale	13-item self-report measure of fatigue	Change from baseline to Day 8, and from baseline to Day 22

Secondary Outcomes

Measure	Description	Time Frame
Change in Mood on the Profile of Mood Scale- Short Form (POMS-SF)	35-items self-report mood scale	Change from baseline to Day 22
Health Related Quality of Life on the Short Form-12 (SF-12) quality of life scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cancer survivor, with no evidence of active disease
≥18 years of age
≥6 months and <10 years post active treatment
Reports being bothered by fatigue in the past month and has a score of <43 on FACIT-F.
Able to read and write in English

Exclusion Criteria:

Being evaluated or likely to be evaluated for a medical cause of fatigue (e.g., anemia, hypothyroidism) during the study. (per provider report)
Have indications of sleep apnea as assessed by Epworth Sleepiness scale score ≥10.
Are receiving, or are likely to receive another intervention for the treatment of fatigue during the study period. (per provider report)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Recklitis, PhD, MPH	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana Farber Cancer Institute		Boston	Massachusetts	02115	United States