FatigueOLPINCT02522988

The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors

A study of Fatigue, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Fatigue
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 1 siteUnited States
Study dates: Jun 2015to 1 Aug 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Stage 1 cancer;
Uncontrolled diabetes;
Uncontrolled COPD;
Uncontrolled ischemic heart disease;
Uncontrolled liver/kidney diseases;
Uncontrolled autoimmune diseases;
Uncontrolled psychiatric or cognitive diseases.

Trial locations and contacts

1 site in 1 country.

United States1 site

UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294

Other trials in United States

About this study

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.

Read the detailed description

The investigators will conduct a pilot randomized-controlled, crossover trial to evaluate the feasibility, acceptability and effect of the open-label administration of placebo pills on CRF and associated psychosocial factors (e.g., emotional health, social health, quality of life, etc.) for cancer survivors (CSs) who have completed all cancer treatments yet continue to experience CRF. Additionally, in an exploratory manner, the investigators will collect DNA saliva specimens that will be analyzed for potential biomarkers that may predict placebo responses. To do this, investigators will use a 7-week, single site, two-parallel arm, randomized controlled crossover pilot study to determine the feasibility, acceptability and effects of an Open Label Placebo Intervention (OLPI) on CSs who completed cancer treatments at least 6 months prior to enrollment in the study and report a fatigue score of 4 or greater on a 0-10 scale. Investigators will enroll 80 eligible CS participants who will be randomized into two groups of 40 (Group1 and Group2 ). In this crossover study, participants in Group1, will receive an OLP (placebo pill) for 21-days (Period 1)and Group2 (Observational Controls) will not. After a 1-week washout period, Group2 will receive the OLP for 21-days (Period 2) and Group1 (Observational Controls) will not.

Conditions: Fatigue
Being tested: Open-label placebo intervention
Keywords: cancer-related fatigue
Medical subject headings: Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Open-label placebo interventionBehavioural
Also called OLPI
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).

Study groups in NCT02522988
Study group	Role	What they receive
Group 1a	Experimental	During the first 3-week period of the study, Group 1 will serve as the experimental arm and will receive the open-label placebo intervention. Group 1 participants will take 2 placebos in the morning and 2 placebos in the evening for 21 days. Receives: Behavioral: Open-label placebo intervention
Group 2a	No intervention	During the first 3-week period of the study, Group 2 will serve as the comparator arm.
Group 1b	No intervention	During the last 3-week period of the study, Group 1 will serve as the comparator arm.
Group 2b	Experimental	During the last 3-week period of the study, Group 2 will serve as the experimental arm and will receive the open-label placebo intervention.Group 2 participants will take 2 placebos in the morning and 2 placebos in the evening for 21 days. Receives: Behavioral: Open-label placebo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Enrollment Rate
Unit of measure: number of enrollees / number of eligible participants as a measure of feasibility.
Measured: End of Study (7 weeks)
Accrual Rate as a Measure of Feasibility
Unit of measure: number of accrued participants / recruitment goal (80); odds ration of expected time-to-first participant/ actual time-to-first patient enrollment.
Measured: End of Study (7 weeks)
Adherence Rate as a Measure of Feasibility
Unit of measure: number of placebos taken / number prescribed (84)
Measured: End of Study (7 weeks)
Eligibility as a measure of Feasibility
Unit of measure: number eligible for enrollment / number screened
Measured: End of Study (7 weeks)
Retention as a measure of Acceptability
Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled
Measured: End of Study (7 weeks)

Secondary outcomes (4)

Measure of fatigue manifestation
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)
Measured: Baseline, 3 weeks, 4 weeks and 7 weeks
Measurement of impact of fatigue on quality of life
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)
Measured: Baseline, 3 weeks, 4 weeks and 7 weeks
Measurement of the impact of fatigue on physical function
Unit of measure: units on a scale using the FACT-Fatigue instrument; scale for impact is 0 = not at all; 10 = very much.
Measured: Baseline, 3 weeks, 4 weeks and 7 weeks
Measurement of fatigue severity
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)
Measured: Baseline, 3 weeks, 4 weeks and 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 20151 Aug 2021

First posted14 Aug 2015 (estimated)
Study startJun 2015
Primary completion1 May 2016
Study completion1 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for FatigueStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02522988
Sponsor's protocol ID: X150506002
Acronym: OLPI
Status last verified: Sep 2021
First submitted: 5 Aug 2015
Last updated: 24 Sep 2021
Results posted: No
Data monitoring committee: No

Publications

Kelley JM, Kaptchuk TJ, Cusin C, Lipkin S, Fava M. Open-label placebo for major depressive disorder: a pilot randomized controlled trial. Psychother Psychosom. 2012;81(5):312-4. doi: 10.1159/000337053. Epub 2012 Aug 1. No abstract available.
PubMed 22854752
Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175.
PubMed 24401940
Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.
PubMed 21203519
Hoenemeyer TW, Baidwan NK, Hall K, Kaptchuk TJ, Fontaine KR, Mehta TS. An Exploratory Analysis of the Association Between Catechol-O-Methyltransferase and Response to a Randomized Open-Label Placebo Treatment for Cancer-Related Fatigue. Front Psychiatry. 2021 Jun 29;12:684556. doi: 10.3389/fpsyt.2021.684556. eCollection 2021.
PubMed 34267689

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult

All Fatigue trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors
ClinicalTrials.gov ID: NCT02522988
Acronym / sponsor ID: OLPI / X150506002
Conditions: Fatigue
Keywords: cancer-related fatigue
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: Jun 2015 (actual)
Primary completion: 1 May 2016 (actual)
Study completion: 1 Aug 2021 (actual)
First posted: 14 Aug 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Group 1a	Experimental	Behavioral: Open-label placebo interventionDuring the first 3-week period of the study, Group 1 will serve as the experimental arm and will receive the open-label placebo intervention. Group 1 participants will take 2 placebos in the morning and 2 placebos in the evening for 21 days.
Group 2a	No intervention	–During the first 3-week period of the study, Group 2 will serve as the comparator arm.
Group 1b	No intervention	–During the last 3-week period of the study, Group 1 will serve as the comparator arm.
Group 2b	Experimental	Behavioral: Open-label placebo interventionDuring the last 3-week period of the study, Group 2 will serve as the experimental arm and will receive the open-label placebo intervention.Group 2 participants will take 2 placebos in the morning and 2 placebos in the evening for 21 days.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

Stage 1 cancer;
Uncontrolled diabetes;
Uncontrolled COPD;
Uncontrolled ischemic heart disease;
Uncontrolled liver/kidney diseases;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Open-label placebo interventionAlso: OLPIAn 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).	Behavioural	Group 1a, Group 2b

Primary outcome

Enrollment Rate
Time frame: End of Study (7 weeks)
Unit of measure: number of enrollees / number of eligible participants as a measure of feasibility.
Accrual Rate as a Measure of Feasibility
Time frame: End of Study (7 weeks)
Unit of measure: number of accrued participants / recruitment goal (80); odds ration of expected time-to-first participant/ actual time-to-first patient enrollment.
Adherence Rate as a Measure of Feasibility
Time frame: End of Study (7 weeks)
Unit of measure: number of placebos taken / number prescribed (84)
Eligibility as a measure of Feasibility
Time frame: End of Study (7 weeks)
Unit of measure: number eligible for enrollment / number screened
Retention as a measure of Acceptability
Time frame: End of Study (7 weeks)
Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled

4 secondary outcomes

Measure of fatigue manifestation
Time frame: Baseline, 3 weeks, 4 weeks and 7 weeks
Measurement of impact of fatigue on quality of life
Time frame: Baseline, 3 weeks, 4 weeks and 7 weeks
Measurement of the impact of fatigue on physical function
Time frame: Baseline, 3 weeks, 4 weeks and 7 weeks
Measurement of fatigue severity
Time frame: Baseline, 3 weeks, 4 weeks and 7 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
Background: PubMed 22854752Kelley JM, Kaptchuk TJ, Cusin C, Lipkin S, Fava M. Open-label placebo for major depressive disorder: a pilot randomized controlled trial. Psychother Psychosom. 2012;81(5):312-4. doi: 10.1159/000337053. Epub 2012 Aug 1. No abstract available.
Background: PubMed 24401940Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175.
Results publication: PubMed 21203519Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.
Derived from this study: PubMed 34267689Hoenemeyer TW, Baidwan NK, Hall K, Kaptchuk TJ, Fontaine KR, Mehta TS. An Exploratory Analysis of the Association Between Catechol-O-Methyltransferase and Response to a Randomized Open-Label Placebo Treatment for Cancer-Related Fatigue. Front Psychiatry. 2021 Jun 29;12:684556. doi: 10.3389/fpsyt.2021.684556. eCollection 2021.
Open Label Placebo EffectsLink provided by the sponsor.

Related trials for Fatigue

Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Fatigue, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment Rate (time frame: End of Study (7 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02522988, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.