NCT06085716

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Cancers
• Fatigue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-16
• Primary completion: 2027-08-31
• Completion: 2029-08-31
• First posted: 2023-10-17
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study