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

NCT ID: NCT02452710

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Fatigue in Cancer Survivors

Keywords

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Fatigue in Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Open-Label Placebo

\- Placebo Tablets-Twice a day for 3-4 weeks

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Open-label placebo

NT-Control

\- No Placebo Tablets

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Placebo

Open-label placebo

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Christopher Recklitis, Ph.D

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Recklitis, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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14-583

Identifier Type: -

Identifier Source: org_study_id