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Trial Title:
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
NCT ID:
NCT06085716
Condition:
Metastatic Cancers
Fatigue
Conditions: Official terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Fatigue
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Psychoeducational Intervention
Description:
Participants in the PI group will complete the educational sessions only.
Arm group label:
Psychoeducational Intervention
Intervention type:
Drug
Intervention name:
Open Label Placebo
Description:
This group will only take placebo capsules every day.
Arm group label:
Open Label Placebo
Intervention type:
Behavioral
Intervention name:
Psychoeducational Intervention+Placebo
Description:
This group will take the placebo capsules every day, as well as completing the
educational sessions.
Arm group label:
Psychoeducational Intervention+Placebo
Summary:
To find out if combining psychoeducational interventions (such as education, counseling,
and self-managed therapies) with an open-label placebo can help to improve your quality
of life better than either the psychoeducational interventions or the placebo alone.
Detailed description:
Primary Objectives:
1. To determine if the combination therapy of PI with OLP (combination therapy group)
is superior to PI alone group in the treatment of cancer-related fatigue (CRF) as
measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
scale.
We hypothesize that the combination of OLP+PI in these patients will result in a greater
reduction of CRF compared to PI alone.
Secondary Objectives:
1. To determine if Combination Therapy group is superior to PI Only group for the
treatment of CRF at 3 months and 6 months after treatment. We hypothesize that the
combination of OLP+PI in these patients will result in a greater reduction of CRF
after 3 months and 6 months after treatment
3. To determine the effects of combination therapy on fatigue-related quality-of-life,
mood, sleep-wake activity, cognitive measures, and inflammation. We will assess
measures including quality of life (Functional Assessment of Cancer Therapy -
General, FACT- G), multidimensional fatigue (Multidimensional Fatigue Symptom
Inventory, MFSI-SF), sleep disturbance (PROMIS-sleep), anxiety (Hospital Anxiety and
Depression Scale - HADS), depressed mood (HADS), cognitive function (Symbol digit
modality test, SDMT), sleep/wake time activity (actigraphy), and inflammation
(C-reactive protein levels).
We hypothesize that combination therapy will result in improvements in CRF-related
quality of life, mood, sleep-wake activity, and cognitive measures.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Be advanced cancer patients (incurable metastatic), having fatigue with severity of
4/10, on a 0-10 scale (Edmonton Symptom Assessment Scale) for at least 2 weeks.
2. Have no clinical evidence of cognitive failure as evidenced by treating clinician
assessment at screening (Memorial Delirium Assessment Scale of less than 13/30).
3. Be aged 18 years or older.
4. Be willing to engage in follow-up in person or by telephone or virtual calls with
research staff.
5. Have a hemoglobin level of ≥10 g/dL within 2 weeks of enrollment.
6. Be able to understand the description of the study and sign a written informed
consent.
7. Have a ECOG performance status score of 0 to 2; and
8. Be seen at an outpatient clinic at MD Anderson Cancer Center's (MDA) main campus or
its Houston Area Locations (HALs)
Exclusion Criteria:
1. Have a major contraindication to placebo (e.g., allergy or hypersensitivity to study
medications or their constituents), or conditions making adherence difficult as
determined by the attending physician.
2. Be unable to complete the baseline assessment forms or to understand the
recommendations for participation in the study.
3. Be pregnant or become pregnant while on study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Centerr
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sriram Yennu, MD
Phone:
713-792-3938
Email:
syennu@mdanderson.org
Investigator:
Last name:
Sriram Yennu, MD
Email:
Principal Investigator
Start date:
February 16, 2024
Completion date:
August 31, 2029
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06085716
http://www.mdanderson.org
