The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients

NCT06125353 | Completed

• 2 other identifiers: 01052022D231052019
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present 3-month randomized, placebo-controlled trial was to evaluate whether adherence to Mediterranean Diet (MD) together with melatonin oral treatment or plaebo, would ameliorate Cancer Related Fatigue in Breast Cancer patients receiving chemotherapy treatment.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Cancer Related Fatigue

  Whether melatonin can ameliorate cancer related fatigue in breast cancer patients. Cancer related fatigue was evaluated by the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire. It is a 40-item scale that assesses self-reported fatigue in terms of daily activities and function. It has five subscale domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Fatigue. For each question there are five answers (Not at all, A little bit, Somewhat, Quite a bit, Very much). Scoring ranges between 0 and 160. The higher the score, the better the participant's well-being.

  three months

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Participants in the Intervention group consumed one melatonin tablet per day, containing 1mg of melatonin, for a total of three months.

Dietary Supplement: Melatonin

placebo group

NO INTERVENTION

Participants in this group were instructed to consume one placebo tablet (with water) every day for a total of three months. Melatonin and placebo tablets were of similar physical and sensory properties.

Interventions

Melatonin DIETARY_SUPPLEMENT

Patients of the Intervention group (melatonin group) received a personalized dietary plan based on the Mediterranean Diet, together with a booklet of lifestyle guidelines (nutritional and physical activity), all generated by a Clinical Decision Support System (CDSS). Moreover, participants in the Intervention group consumed one melatonin tablet per day, containing 1 mg of melatonin, together with water for a total of three months.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult women (≥ 18 years of age) with BC diagnosis who underwent chemotherapy at the time of invitation,
• women receiving pharmacological treatment that did not interact with melatonin,
• women receiving standard pharmacological treatment for at least last two months prior to study initiation,
• patients with good performance status, as indicated by scoring "0 or 1" of the Eastern Cooperative Oncology Performance Status (ECOG PS) questionnaire \[26\],
• patients not needing a transfusion, as indicated by hemoglobin ≥ 9 g/dL,
• patients having the ability to understand and give a written statement of consent.
• Patients were excluded from the study when:
• fatigue was attributed to conditions other than cancer e.g., uncontrolled hypothyroidism, hypercalcemia, congestive heart failure, chronic obstructive pulmonary disease,
• using pharmacological agents for CRF or sleeping disorders prior to the study,
• pharmacological treatment that was modified during the study or that could interact with melatonin,
• diagnosed with gastrointestinal diseases that could affect absorption of nutrients such as inflammatory bowel diseases infections.
• diagnosed with psychiatric disorders such as depression, psychosis, bipolar disorder, and receiving equivalent medication.
• excessive alcohol consumption.
• a lifestyle that can affect sleep patterns (e.g., night shifts).
• patients with a poor clinical state as indicated by laboratory markers: creatinine clearance \< 30 mL/min; aspartate aminotransferase (AST) \> 3 x upper limit of normal (ULN); alanine aminotransferase (ALT) \> 3 x ULN; bilirubin \> 1 x ULN.

Sponsors & Collaborators

• Harokopio University: lead

Study Sites (1)

Iaso Hospital

Athens, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Maria Skouroliakou, Dr

  Harokopio University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: November 9, 2023
• Study Start: January 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

GR (1)