Fatigue
Conditions
Keywords
cancer-related fatigue
Brief summary
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.
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.
Interventions
BEHAVIORALOpen-label placebo intervention
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).
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Stage 1 cancer; * Uncontrolled diabetes; * Uncontrolled COPD; * Uncontrolled ischemic heart disease; * Uncontrolled liver/kidney diseases; * Uncontrolled autoimmune diseases; * Uncontrolled psychiatric or cognitive diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention as a measure of Acceptability | End of Study (7 weeks) | Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled |
| Enrollment Rate | 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 | 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 | End of Study (7 weeks) | Unit of measure: number of placebos taken / number prescribed (84) |
| Eligibility as a measure of Feasibility | End of Study (7 weeks) | Unit of measure: number eligible for enrollment / number screened |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of fatigue manifestation | Baseline, 3 weeks, 4 weeks and 7 weeks | 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) |
| Measurement of impact of fatigue on quality of life | Baseline, 3 weeks, 4 weeks and 7 weeks | 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) |
| Measurement of the impact of fatigue on physical function | Baseline, 3 weeks, 4 weeks and 7 weeks | Unit of measure: units on a scale using the FACT-Fatigue instrument; scale for impact is 0 = not at all; 10 = very much. |
| Measurement of fatigue severity | Baseline, 3 weeks, 4 weeks and 7 weeks | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Test for the presence of a COMT Val158Met/Val or Val/Val variant gene | Baseline | Investigators will collect and store saliva samples so, should significant OLPI effects be obtained, we can evaluate whether a potential biomarker (COMT Val158Met variant) associates with placebo responsiveness. |
Countries
United States
Outcome results
None listed