NCT02452710

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

1.5 years

First QC Date

May 19, 2015

Last Update Submit

December 10, 2018

Conditions

Fatigue in Cancer Survivors

Keywords

Fatigue in Cancer Survivors

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Change in Mood on the Profile of Mood Scale- Short Form (POMS-SF)

    Change from baseline to Day 22

  • Health Related Quality of Life on the Short Form-12 (SF-12) quality of life scale

    Change from baseline to Day 22

  • Subjective Sense of Change on fatigue, readiness for exercise and quality of life

    Change from baseline to Day 8, and change from Baseline to Day 22

Study Arms (2)

Open-Label Placebo

EXPERIMENTAL

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

Other: Placebo

NT-Control

NO INTERVENTION

\- No Placebo Tablets

Interventions

PlaceboOTHER

Open-label placebo

Open-Label Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Christopher Recklitis, PhD, MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 25, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations

US(1)