Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Fatigue Clinical Trial

Official title:

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085716
• Other study ID #: 2023-0466
• Secondary ID: NCI-2023-08682
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 16, 2024
• Est. completion date: August 31, 2029

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Sriram Yennu, MD
• Phone: (713) 792-3938
• Email: syennu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 31, 2029
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Metastatic Cancers
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

Behavioral:
• Psychoeducational Intervention
Participants in the PI group will complete the educational sessions only.

Drug:
• Open Label Placebo
This group will only take placebo capsules every day.

Behavioral:
• Psychoeducational Intervention+Placebo
This group will take the placebo capsules every day, as well as completing the educational sessions.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Centerr	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0		through study completion; an average of 1 year

External Links

•   M D Anderson Cancer Center